Patellofemoral OsteoarthritisNCT04332900
Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis
A study testing Elastic hip strap and Insole in people with Patellofemoral Osteoarthritis, run by Universidade Federal de Sao Carlos.
Trial summary
This is a crossover study that will investigate the immediate effects of a proximal therapeutic approach (SERF strap) and a distal one (foot orthoses) on knee pain intensity, global change, symptoms, ease of performance and confidence after each task and lower limb kinematics (hip adduction and internal hip rotation… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Patellofemoral Osteoarthritis
- What is being tested?
- Elastic hip strap and Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present anterior or retro patellar pain aggravated by two or more activities that overload the patellofemoral joint, such as going up and down stairs, squatting, remaining in the sitting position for long periods, getting up from the sitting position, kneeling or during physical exercise;
- Reporting pain of at least 3 on an 11-point scale (0 for no pain and 10 for the worst possible pain) during the activities described above and on most days during the last month;
- Have evidence of osteophyte formation in the patellofemoral joint on radiographs in the profile and axial skyline views through the Kellgren-Lawrence (K-L) grade ≥ 2, with minimal impairment in the tibiofemoral joint (KL <2);
- Body mass index (BMI) <35 Kg / m². Participants with unilateral or bilateral symptoms will be included in the study.
Who cannot join
- Current use or in the last 12 months of foot orthoses;
- Previous history of fracture or recurrent subluxation of the patella;
- Arthroscopic surgery or knee infiltrations in the last 3 months;
- Osteoarthritis known in other weight-bearing joints, including the spine;
- History of surgery on the hip, knee, ankle and foot joints;
- History of ankle sprain in the last 12 months;
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- Osteotomy in the lower limbs;
- Current physical therapy in the lower limbs or in the last 6 weeks;
- Use of a cane or other walking aid;
- Any physical disability that is a contraindication for carrying out the evaluations and;
- Punctuation that suggests dementia according to the Mini-Mental State Examination, taking into account the education of the participants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Immediate Effects of a Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic During Functional Tasks in People With Patellofemoral Osteoarthritis: A Crossover Study
This is a crossover study that will investigate the immediate effects of a proximal therapeutic approach (SERF strap) and a distal one (foot orthoses) on knee pain intensity, global change, symptoms, ease of performance and confidence after each task and lower limb kinematics (hip adduction and internal hip rotation peak, rearfoor eversion peak) during functional taks (level-ground walking and stepping manoeuvres) in people with patellofemoral ostheoartritis
Read the detailed description
It will be enroled in this study 30 participants with patellofemoral ostheoartritis. The participants will be assessed during level walking at a self-selected speed and the stepping manoeuvre test under the three conditions that will be randomized: i) the control condition; ii) intervention proximal condition; and iii) intervention distal condition. The control condition refers to the condition in which no interventions will be administered. In both the intervention proximal condition and intervention distal condition, the respective therapeutic approach will be administered. For each functional task, three valid attempts will be collected. The primary outcome of this study is knee pain intensity and the secondary outcomes are both self-reported measures and kinematic variables measures. The self-reported measures are global change, symptoms, ease of performance and confidence, while the kinematic variables measures are hip adduction and internal hip rotation peak and rearfoor eversion peak
- Conditions
- Patellofemoral Osteoarthritis
- Being tested
- Elastic hip strap, Insole
- Keywords
- Knee osteoarthritis, Patellofemoral joint, Gait, Pain, Quality of life, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic hip strapDevice
Also called S.E.R.F. Strap; DonJoy Orthopedics, Inc, vista, CA
The SERF Strap consist of a thin, elastic material that is secured to the proximal aspect of the leg, wraps in a spiral fashion around the thigh, and is anchored around the pelvis. The line of action of the SERF Strap pulls the hip into abdcution and external rotation.
InsoleDevice
Also called Propulsão Produtos Biomecânicos, Minas Gerais, Brasil
Foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each that is made from a block of ethyl vinyl acetate with a thermo-moldable polymer (shore hardness of 45 A) and is manufactured through an automated computer numeric control machine (CNC routers).
| Study group | Role | What they receive |
|---|---|---|
| Control condition | No intervention | In this condition there will not be any application of therapeutic approach. |
| Intervention proximal condition | Experimental | The proximal therapeutic approach will be the SERF strap (S.E.R.F. strap; DonJoy Orthopedics, Inc., vista, CA). Receives: Device: Elastic hip strap |
| Intervention distal condition | Experimental | The distal therapeutic approach will be a pair of foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each (Propulsão Produtos Biomecânicos, Minas Gerais, Brazil). Receives: Device: Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Proximal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Distal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Intervention Distal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Control Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Control Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Pain intensity
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Measured: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Secondary outcomes (74)
A global rating of change change (GRC) questionnaire
The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.
Measured: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
A global rating of change change (GRC) questionnaire
The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.
Measured: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
A global rating of change change (GRC) questionnaire
The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.
Measured: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
A global rating of change change (GRC) questionnaire
The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.
Measured: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Acceptable state of the patient's symptoms
The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".
Measured: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Proximal Condition
Acceptable state of the patient's symptoms
The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".
Measured: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Distal Condition
Acceptable state of the patient's symptoms
The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".
Measured: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Acceptable state of the patient's symptoms
The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".
Measured: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Ease of performing a task
Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Measured: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Ease of performing a task
Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Measured: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Ease of performing a task
Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Measured: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Ease of performing a task
Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Measured: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Ease of performing a task
Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Measured: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Ease of performing a task
Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Measured: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Knee confidence
The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
Measured: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Knee confidence
The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
Measured: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Knee confidence
The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
Measured: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Knee confidence
The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
Measured: The knee confidence will assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Knee confidence
The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
Measured: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Knee confidence
The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
Measured: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the gait of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot of Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Measured: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Nov 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised cross-over desing
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Larissa Rodrigues Souto, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332900
- Sponsor's protocol ID
- 2020/01599-7
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
Souto LR, Serrao PRMDS, Pisani GK, Tessarin BM, da Silva HF, Machado EM, de Oliveira Sato T, Serrao FV. Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial. Trials. 2022 Sep 5;23(1):746. doi: 10.1186/s13063-022-06676-0.
PubMed 36064729
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immediate Effects of a Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic During Functional Tasks in People With Patellofemoral Osteoarthritis: A Crossover Study
- ClinicalTrials.gov ID
- NCT04332900
- Acronym / sponsor ID
- 2020/01599-7
- Conditions
- Patellofemoral Osteoarthritis
- Keywords
- Knee osteoarthritis, Patellofemoral joint, Gait, Pain, Quality of life, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a crossover study that will investigate the immediate effects of a proximal therapeutic approach (SERF strap) and a distal one (foot orthoses) on knee pain intensity, global change, symptoms, ease of performance and confidence after each task and lower limb kinematics (hip adduction and internal hip rotation peak, rearfoor eversion peak) during functional taks (level-ground walking and stepping manoeuvres) in people with patellofemoral ostheoartritis
Detailed description
It will be enroled in this study 30 participants with patellofemoral ostheoartritis. The participants will be assessed during level walking at a self-selected speed and the stepping manoeuvre test under the three conditions that will be randomized: i) the control condition; ii) intervention proximal condition; and iii) intervention distal condition. The control condition refers to the condition in which no interventions will be administered. In both the intervention proximal condition and intervention distal condition, the respective therapeutic approach will be administered. For each functional task, three valid attempts will be collected. The primary outcome of this study is knee pain intensity and the secondary outcomes are both self-reported measures and kinematic variables measures. The self-reported measures are global change, symptoms, ease of performance and confidence, while the kinematic variables measures are hip adduction and internal hip rotation peak and rearfoor eversion peak
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomised cross-over desing
| Arm | Type | Receives |
|---|---|---|
| Control condition | No intervention | –In this condition there will not be any application of therapeutic approach. |
| Intervention proximal condition | Experimental | Device: Elastic hip strapThe proximal therapeutic approach will be the SERF strap (S.E.R.F. strap; DonJoy Orthopedics, Inc., vista, CA). |
| Intervention distal condition | Experimental | Device: InsoleThe distal therapeutic approach will be a pair of foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each (Propulsão Produtos Biomecânicos, Minas Gerais, Brazil). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Present anterior or retro patellar pain aggravated by two or more activities that overload the patellofemoral joint, such as going up and down stairs, squatting, remaining in the sitting position for long periods, getting up from the sitting position, kneeling or during physical exercise;
- Reporting pain of at least 3 on an 11-point scale (0 for no pain and 10 for the worst possible pain) during the activities described above and on most days during the last month;
- Have evidence of osteophyte formation in the patellofemoral joint on radiographs in the profile and axial skyline views through the Kellgren-Lawrence (K-L) grade ≥ 2, with minimal impairment in the tibiofemoral joint (KL <2);
- Body mass index (BMI) <35 Kg / m². Participants with unilateral or bilateral symptoms will be included in the study.
Key exclusion criteria (11 listed)
- Current use or in the last 12 months of foot orthoses;
- Previous history of fracture or recurrent subluxation of the patella;
- Arthroscopic surgery or knee infiltrations in the last 3 months;
- Osteoarthritis known in other weight-bearing joints, including the spine;
- History of surgery on the hip, knee, ankle and foot joints;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic hip strapAlso: S.E.R.F. Strap; DonJoy Orthopedics, Inc, vista, CAThe SERF Strap consist of a thin, elastic material that is secured to the proximal aspect of the leg, wraps in a spiral fashion around the thigh, and is anchored around the pelvis. The line of action of the SERF Strap pulls the hip into abdcution and external rotation. | Device | Intervention proximal condition |
| InsoleAlso: Propulsão Produtos Biomecânicos, Minas Gerais, BrasilFoot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each that is made from a block of ethyl vinyl acetate with a thermo-moldable polymer (shore hardness of 45 A) and is manufactured through an automated computer numeric control machine (CNC routers). | Device | Intervention distal condition |
Primary outcome
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Proximal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Distal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Intervention Distal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Control Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Control Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
Pain intensity
Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable
74 secondary outcomes
A global rating of change change (GRC) questionnaire
Time frame: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
A global rating of change change (GRC) questionnaire
Time frame: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
A global rating of change change (GRC) questionnaire
Time frame: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
A global rating of change change (GRC) questionnaire
Time frame: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Acceptable state of the patient's symptoms
Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Proximal Condition
Acceptable state of the patient's symptoms
Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Distal Condition
Acceptable state of the patient's symptoms
Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Acceptable state of the patient's symptoms
Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Ease of performing a task
Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Ease of performing a task
Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Ease of performing a task
Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Ease of performing a task
Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Ease of performing a task
Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Ease of performing a task
Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Knee confidence
Time frame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Knee confidence
Time frame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Knee confidence
Time frame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Knee confidence
Time frame: The knee confidence will assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Knee confidence
Time frame: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Knee confidence
Time frame: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the gait of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction
Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation
Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion
Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion
Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Derived from this study: PubMed 36064729Souto LR, Serrao PRMDS, Pisani GK, Tessarin BM, da Silva HF, Machado EM, de Oliveira Sato T, Serrao FV. Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial. Trials. 2022 Sep 5;23(1):746. doi: 10.1186/s13063-022-06676-0.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic hip strap and Insole in people with Patellofemoral Osteoarthritis, run by Universidade Federal de Sao Carlos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Larissa R Souto, MSc (+55(18)988052128, larissasouto@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.