Knee OsteoarthritisNCT04154059
Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis
A study testing Intervention Group in people with Knee Osteoarthritis, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jan 2020to 4 Aug 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
- KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
- Knee pain between 30 and 80 on the visual analogue scale;
- BMI < 35 kg/m2.
Who cannot join
- KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
- Lower limb strength training (3 times per week);
- Wear minimalist shoes for at least 6 hours a day and 5 days a week;
- Physical therapy in the previous 3 months;
- Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
- Previous history of surgery on knees, ankles and hips in the last 2 years;
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- Neurological disease;
- Inflammatory arthritis (eg. rheumatoid arthritis);
- Asymptomatic OA of one or both knees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Strengthening Program for Foot-ankle Muscles in Clinical Aspects and Gait Biomechanics of People With Knee Osteoarthritis: a Randomized Blinded Clinical Trial
The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.
Read the detailed description
A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up).
The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intervention Group
- Keywords
- Rehabilitation, Arthrosis, Therapeutic exercises, Feet
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Also called Foot and ankle kinesiotherapy
Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients will receive a physical therapy intervention three times per week, for 8 weeks. Receives: Other: Intervention Group |
| Control Group | No intervention | Patients will not receive any exercise treatment but they will keep their recommended clinical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
The WOMAC pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.
Measured: Baseline, 8 weeks and 16 weeks.
Secondary outcomes (11)
Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.
The stiffness subscale included in the WOMAC index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.
Measured: Baseline, 8 weeks and 16 weeks.
Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.
he physical function subscale included in the WOMAC index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.
Measured: Baseline, 8 weeks and 16 weeks.
Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks
The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme.
Measured: Baseline, 8 weeks and 16 weeks.
30-second Chair Stand Test
The maximum number of chair stand repetitions possible in a 30 second period.
Measured: Baseline, 8 weeks and 16 weeks.
9-step Stair Climb Test
The time (in seconds) it takes to ascend and descend a flight of stairs. Where possible, the 9-step stair test with 20cm (8 inch) step height and handrail is recommended.
Measured: Baseline, 8 weeks and 16 weeks.
40m (4x10m) Fast Paced Walk Test
A test of walking speed over short distances and changing direction during walking. A fast-paced walking test that is timed over 4 x 10m for a total 40 m (convert time to speed).
Measured: Baseline, 8 weeks and 16 weeks.
Foot strength
Hallux and lesser toes force measured by a pressure plate
Measured: Baseline, 8 weeks and 16 weeks.
Foot Kinematics during gait
Foot joints and plantar arch motion during gait.The kinematics outcomes will be evaluate by mean inverse dynamics approach. To this procedure, we will use the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform.
Measured: Baseline, 8 weeks and 16 weeks.
Knee joint moments during gait
Peak joint moment by inverse dynamic calculations. To this procedure, we will use the kinematics and kinetics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform.
Measured: Baseline, 8 weeks and 16 weeks.
Global Rating of Change Scale
GRCS assesses the clinical change perceived by the patient by comparing the onset of symptoms before and after treatment. "With respect to your knee injury, how do you describe your situation now compared to the start of treatment?" This numerical scale consists of 11 points (from -5 to +5: -5, extremely worse; 0, unchanged; +5, fully recovered). Higher scores indicate better recovery from the condition.
Measured: 8 weeks and 16 weeks.
Paracetamol intake
Paracetamol intake (500 mg), number of tablets per month.
Measured: Baseline, 8 weeks and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start27 Jan 2020
- Primary completion1 Mar 2020
- Study completion4 Aug 2023
Why it stopped: The recruitment of potential participants is suspended due to the covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Glauko André de Figueiredo Dantas, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154059
- Sponsor's protocol ID
- LabPlastUFSCar
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2019
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected during the trial will be compiled electronically. Data integrity and validity will be verified at the time of data entry (edit checks). The project manager and research assistant will regularly monitor the study datasets and make recommendations regarding necessary protocol modifications or termination of all or part of the study. Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication. In addition, the study protocol and clinical trial report (both with the planned statistical analysis) will be made available by the researchers who proposed the methodology. Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.
Publications
Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.
PubMed 32978204Dantas GAF, Sacco ICN, Ferrari AV, Matias AB, Watari R, Oliveira LVM, Marcon TR, Fatore JA, Pott-Junior H, Salvini TF. Effects of a foot-ankle muscle strengthening program on pain and function in individuals with knee osteoarthritis: a randomized controlled trial. Braz J Phys Ther. 2023 Jul-Aug;27(4):100531. doi: 10.1016/j.bjpt.2023.100531. Epub 2023 Aug 11.
PubMed 37603935
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Strengthening Program for Foot-ankle Muscles in Clinical Aspects and Gait Biomechanics of People With Knee Osteoarthritis: a Randomized Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04154059
- Acronym / sponsor ID
- LabPlastUFSCar
- Conditions
- Knee Osteoarthritis
- Keywords
- Rehabilitation, Arthrosis, Therapeutic exercises, Feet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment of potential participants is suspended due to the covid-19 pandemic.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 6 Nov 2019 (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.
The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.
Detailed description
A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up).
The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention GroupPatients will receive a physical therapy intervention three times per week, for 8 weeks. |
| Control Group | No intervention | –Patients will not receive any exercise treatment but they will keep their recommended clinical treatment. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
- KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
- Knee pain between 30 and 80 on the visual analogue scale;
- BMI < 35 kg/m2.
Key exclusion criteria (9 listed)
- KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
- Lower limb strength training (3 times per week);
- Wear minimalist shoes for at least 6 hours a day and 5 days a week;
- Physical therapy in the previous 3 months;
- Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
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 |
|---|---|---|
| Intervention GroupAlso: Foot and ankle kinesiotherapyPatients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot. | Other | Intervention Group |
Primary outcome
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
Time frame: Baseline, 8 weeks and 16 weeks.
The WOMAC pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.
11 secondary outcomes
Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.
Time frame: Baseline, 8 weeks and 16 weeks.
Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.
Time frame: Baseline, 8 weeks and 16 weeks.
Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks
Time frame: Baseline, 8 weeks and 16 weeks.
30-second Chair Stand Test
Time frame: Baseline, 8 weeks and 16 weeks.
9-step Stair Climb Test
Time frame: Baseline, 8 weeks and 16 weeks.
40m (4x10m) Fast Paced Walk Test
Time frame: Baseline, 8 weeks and 16 weeks.
Foot strength
Time frame: Baseline, 8 weeks and 16 weeks.
Foot Kinematics during gait
Time frame: Baseline, 8 weeks and 16 weeks.
Knee joint moments during gait
Time frame: Baseline, 8 weeks and 16 weeks.
Global Rating of Change Scale
Time frame: 8 weeks and 16 weeks.
Paracetamol intake
Time frame: Baseline, 8 weeks and 16 weeks.
Results and safety
The study was stopped early (reason given: The recruitment of potential participants is suspended due to the covid-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Results publication: PubMed 32978204Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.
- Results publication: PubMed 37603935Dantas GAF, Sacco ICN, Ferrari AV, Matias AB, Watari R, Oliveira LVM, Marcon TR, Fatore JA, Pott-Junior H, Salvini TF. Effects of a foot-ankle muscle strengthening program on pain and function in individuals with knee osteoarthritis: a randomized controlled trial. Braz J Phys Ther. 2023 Jul-Aug;27(4):100531. doi: 10.1016/j.bjpt.2023.100531. Epub 2023 Aug 11.
- Individual participant dataSharing planned: Yes. All data collected during the trial will be compiled electronically. Data integrity and validity will be verified at the time of data entry (edit checks). The project manager and research assistant will regularly monitor the study datasets and make recommendations regarding necessary protocol modifications or termination of all or part of the study. Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication. In addition, the study protocol and clinical trial report (both with the planned statistical analysis) will be made available by the researchers who proposed the methodology. Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Knee Osteoarthritis, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 9 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: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: The recruitment of potential participants is suspended due to the covid-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks. (time frame: Baseline, 8 weeks and 16 weeks.). 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 NCT04154059, which also lists 2 linked publications.
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 2 Apr 2025.