Lower Extremity ProblemPROM_RNCT06206018
Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care
A study testing PROM_R knee rehabilitation program in people with Lower Extremity Problem and Rehabilitation, run by University of Évora at 1 site in Portugal.
Trial summary
Different musculoskeletal conditions affect people all over the world and were considered by the WHO to be the leading cause of disability in 4 out of 6 regions in 2017, with an increase in the associated burden and impact on society expected in the coming years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Extremity Problem, Rehabilitation, Knee Injuries
- What is being tested?
- PROM_R knee rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Sep 2023to 31 May 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with knee and ankle pathology, undergoing surgery;
- That they are going to start a rehabilitation program in two Rehabilitation Clinics in coastal and inland regions of Portugal;
- Aged between 18 and 80;
- Have signed an informed consent form.
Who cannot join
- Unconsolidated fractures;
- Previous surgeries in the ipsilateral knee;
- Partial or total amputation in upper or lower limbs;
- Permanent or temporary dysfunctions of the central or peripheral nerve system.
Trial locations and contacts
1 site in 1 country.
About this study
Different musculoskeletal conditions affect people all over the world and were considered by the WHO to be the leading cause of disability in 4 out of 6 regions in 2017, with an increase in the associated burden and impact on society expected in the coming years.
The knee is a complex joint, vulnerable to various types of injury. The most common are ligament, meniscus and cartilage injuries of different etiologies.
Read more
After surgery, as a result of the reflex inhibition of motor neurons and immobilization, there is rapid atrophy and weakness in the different associated muscles, affecting proprioception, muscle strength and extension, clearly compromising health-related quality of life.
Through partnership and collaboration between health institutions and academia, the rehabilitation program will take place on an outpatient basis in a supervised manner, allowing its effectiveness to be assessed using Patient-Reported Outcome Measures. These instruments are a rapidly developing topic and it is essential to understand whether the Patient-Reported Outcome Measures used are sufficient to measure the results perceived by patients with lower limb pathology who take part in rehabilitation programs.
The different Patient-Reported Outcome Measures will be applied before and after the program.
Read the detailed description
The study design is a clinical trial with longitudinal assessment, with a convenience sample. Participants who meet the inclusion criteria are invited to take part and sign an informed consent form. All participants' data is encrypted and stored with password protection, and will be deleted once the results of the study have been published.
The experimental group followed the program for 4 weeks with a treatment frequency of 5 sessions per week, performed and supervised by the same specialist physiotherapist at every session.
For the statistical analysis of the data in this study, we used the Statistical Package for Social Sciences (SPSS®) 29 software.
- Conditions
- Lower Extremity Problem, Rehabilitation, Knee Injuries
- Being tested
- PROM_R knee rehabilitation program
- Keywords
- Quality of Life, Patient-Reported Outcome Measures
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROM_R knee rehabilitation programProcedure or surgery
The rehabilitation program consists of 5 weekly sessions for 4 weeks, supervised by a specialized physiotherapist at every session.
All patients follow the same order of treatment and exercises, starting with massage and mobilization, followed by the corresponding exercise program, and ending with Neuromuscular Electrical Stimulation (NMES) and cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PROM_R Knee | Experimental | Completed a rehabilitation program based on the updated Journal of Orthopaedic and Sports Physical Therapy (JOSPT) guidelines for knee injuries. These guidelines essentially refer to lower limb massage, mobilization, neuromuscular strengthening and rehabilitation, exercise literacy, neuromuscular electrical stimulation and cryotherapy.
The intervention group will complete the four-week rehabilitation program, with five sessions per week, performed and supervised by the physiotherapist. Receives: Procedure: PROM_R knee rehabilitation program |
| Crontrol Group | No intervention | The control group will follow a standard six-week rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
The EuroQol scale (EQ5D) makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean better quality of life and lower scores indicate lower quality of life.
Measured: Before the intervention, after 4-6 weeks and 6 months.
Hospital Anxiety and Depression Scale
Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients with lower extremity problem. This questionnaire is made up of 14 questions. It is subdivided into two subscales - Anxiety and Depression. Each subscale has a maximum score of 21 points and the score for each subscale is analyzed separately. Scores from 0 to 7 indicate unlikely anxiety or depression; scores from 8 to 11 indicate possible but questionable anxiety or depression; scores from 12 to 21 indicate probable anxiety or depression.
Measured: Before the intervention, after 4-6 weeks and 6 months.
Behavioural Regulations in Exercise Questionnaire
Assessment of the different aspects of motivational regulation for exercise. It is a questionnaire that evaluates and represents the differences in the ways in which people's behaviour can be regulated and how these differences are experienced. It consists of 19 items with five Likert-type response options, where 0 is 'not true for me' and 4 is 'often true for me'. This instrument assesses the following constructs: amotivation, external, introjected and identified regulation and intrinsic motivation. The results can vary from 24 (lowest self-determination) to 20 (highest self-determination).
Measured: Before the intervention, after 4-6 weeks and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start10 Sep 2023
- Primary completion1 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity ProblemStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Afonso Moreira, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206018
- Sponsor's protocol ID
- CE-ENSP 3/2022
- Acronym
- PROM_R
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logerstedt DS, Scalzitti DA, Bennell KL, Hinman RS, Silvers-Granelli H, Ebert J, Hambly K, Carey JL, Snyder-Mackler L, Axe MJ, McDonough CM. Knee Pain and Mobility Impairments: Meniscal and Articular Cartilage Lesions Revision 2018. J Orthop Sports Phys Ther. 2018 Feb;48(2):A1-A50. doi: 10.2519/jospt.2018.0301.
PubMed 29385940Mundermann A, Dyrby CO, Andriacchi TP. Secondary gait changes in patients with medial compartment knee osteoarthritis: increased load at the ankle, knee, and hip during walking. Arthritis Rheum. 2005 Sep;52(9):2835-44. doi: 10.1002/art.21262.
PubMed 16145666Suchomel TJ, Nimphius S, Bellon CR, Stone MH. The Importance of Muscular Strength: Training Considerations. Sports Med. 2018 Apr;48(4):765-785. doi: 10.1007/s40279-018-0862-z.
PubMed 29372481Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, Filippatos GS, Hardman S, Hoes AW, Hutchison S, Jessup M, Kinsella T, Knapton M, Lam CSP, Masoudi FA, McIntyre H, Mindham R, Morgan L, Otterspoor L, Parker V, Persson HE, Pinnock C, Reid CM, Riley J, Stevenson LW, McDonagh TA. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC Heart Fail. 2020 Mar;8(3):212-222. doi: 10.1016/j.jchf.2019.09.007. Epub 2019 Dec 11.
PubMed 31838032Moreira J, Joao A, Aguiar P, Raimundo A, Mesquita M, Flaminio J, Almeida M, Boto P. Health-related quality of life after rehabilitation from knee surgery in rural and urban settings: a quasi-experimental study. BMC Musculoskelet Disord. 2024 Dec 19;25(1):1027. doi: 10.1186/s12891-024-08143-0.
PubMed 39702069
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care
- ClinicalTrials.gov ID
- NCT06206018
- Acronym / sponsor ID
- PROM_R / CE-ENSP 3/2022
- Conditions
- Lower Extremity Problem, Rehabilitation, Knee Injuries
- Keywords
- Quality of Life, Patient-Reported Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 Jan 2024 (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.
Different musculoskeletal conditions affect people all over the world and were considered by the WHO to be the leading cause of disability in 4 out of 6 regions in 2017, with an increase in the associated burden and impact on society expected in the coming years.
The knee is a complex joint, vulnerable to various types of injury. The most common are ligament, meniscus and cartilage injuries of different etiologies.
After surgery, as a result of the reflex inhibition of motor neurons and immobilization, there is rapid atrophy and weakness in the different associated muscles, affecting proprioception, muscle strength and extension, clearly compromising health-related quality of life.
Through partnership and collaboration between health institutions and academia, the rehabilitation program will take place on an outpatient basis in a supervised manner, allowing its effectiveness to be assessed using Patient-Reported Outcome Measures. These instruments are a rapidly developing topic and it is essential to understand whether the Patient-Reported Outcome Measures used are sufficient to measure the results perceived by patients with lower limb pathology who take part in rehabilitation programs.
The different Patient-Reported Outcome Measures will be applied before and after the program.
Detailed description
The study design is a clinical trial with longitudinal assessment, with a convenience sample. Participants who meet the inclusion criteria are invited to take part and sign an informed consent form. All participants' data is encrypted and stored with password protection, and will be deleted once the results of the study have been published.
The experimental group followed the program for 4 weeks with a treatment frequency of 5 sessions per week, performed and supervised by the same specialist physiotherapist at every session.
For the statistical analysis of the data in this study, we used the Statistical Package for Social Sciences (SPSS®) 29 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROM_R Knee | Experimental | Procedure: PROM_R knee rehabilitation programCompleted a rehabilitation program based on the updated Journal of Orthopaedic and Sports Physical Therapy (JOSPT) guidelines for knee injuries. These guidelines essentially refer to lower limb massage, mobilization, neuromuscular strengthening and rehabilitation, exercise literacy, neuromuscular electrical stimulation and cryotherapy. The intervention group will complete the four-week rehabilitation program, with five sessions per week, performed and supervised by the physiotherapist. |
| Crontrol Group | No intervention | –The control group will follow a standard six-week rehabilitation program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with knee and ankle pathology, undergoing surgery;
- That they are going to start a rehabilitation program in two Rehabilitation Clinics in coastal and inland regions of Portugal;
- Aged between 18 and 80;
- Have signed an informed consent form.
Key exclusion criteria (4 listed)
- Unconsolidated fractures;
- Previous surgeries in the ipsilateral knee;
- Partial or total amputation in upper or lower limbs;
- Permanent or temporary dysfunctions of the central or peripheral nerve system.
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 |
|---|---|---|
| PROM_R knee rehabilitation programThe rehabilitation program consists of 5 weekly sessions for 4 weeks, supervised by a specialized physiotherapist at every session. All patients follow the same order of treatment and exercises, starting with massage and mobilization, followed by the corresponding exercise program, and ending with Neuromuscular Electrical Stimulation (NMES) and cryotherapy. | Procedure or surgery | PROM_R Knee |
Primary outcome
Health-related quality of life
Time frame: Before the intervention, after 4-6 weeks and 6 months.
The EuroQol scale (EQ5D) makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean better quality of life and lower scores indicate lower quality of life.
Hospital Anxiety and Depression Scale
Time frame: Before the intervention, after 4-6 weeks and 6 months.
Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients with lower extremity problem. This questionnaire is made up of 14 questions. It is subdivided into two subscales - Anxiety and Depression. Each subscale has a maximum score of 21 points and the score for each subscale is analyzed separately. Scores from 0 to 7 indicate unlikely anxiety or depression; scores from 8 to 11 indicate possible but questionable anxiety or depression; scores from 12 to 21 indicate probable anxiety or depression.
Behavioural Regulations in Exercise Questionnaire
Time frame: Before the intervention, after 4-6 weeks and 6 months.
Assessment of the different aspects of motivational regulation for exercise. It is a questionnaire that evaluates and represents the differences in the ways in which people's behaviour can be regulated and how these differences are experienced. It consists of 19 items with five Likert-type response options, where 0 is 'not true for me' and 4 is 'often true for me'. This instrument assesses the following constructs: amotivation, external, introjected and identified regulation and intrinsic motivation. The results can vary from 24 (lowest self-determination) to 20 (highest self-determination).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Results publication: PubMed 29385940Logerstedt DS, Scalzitti DA, Bennell KL, Hinman RS, Silvers-Granelli H, Ebert J, Hambly K, Carey JL, Snyder-Mackler L, Axe MJ, McDonough CM. Knee Pain and Mobility Impairments: Meniscal and Articular Cartilage Lesions Revision 2018. J Orthop Sports Phys Ther. 2018 Feb;48(2):A1-A50. doi: 10.2519/jospt.2018.0301.
- Results publication: PubMed 16145666Mundermann A, Dyrby CO, Andriacchi TP. Secondary gait changes in patients with medial compartment knee osteoarthritis: increased load at the ankle, knee, and hip during walking. Arthritis Rheum. 2005 Sep;52(9):2835-44. doi: 10.1002/art.21262.
- Results publication: PubMed 29372481Suchomel TJ, Nimphius S, Bellon CR, Stone MH. The Importance of Muscular Strength: Training Considerations. Sports Med. 2018 Apr;48(4):765-785. doi: 10.1007/s40279-018-0862-z.
- Results publication: PubMed 31838032Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, Filippatos GS, Hardman S, Hoes AW, Hutchison S, Jessup M, Kinsella T, Knapton M, Lam CSP, Masoudi FA, McIntyre H, Mindham R, Morgan L, Otterspoor L, Parker V, Persson HE, Pinnock C, Reid CM, Riley J, Stevenson LW, McDonagh TA. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC Heart Fail. 2020 Mar;8(3):212-222. doi: 10.1016/j.jchf.2019.09.007. Epub 2019 Dec 11.
- Derived from this study: PubMed 39702069Moreira J, Joao A, Aguiar P, Raimundo A, Mesquita M, Flaminio J, Almeida M, Boto P. Health-related quality of life after rehabilitation from knee surgery in rural and urban settings: a quasi-experimental study. BMC Musculoskelet Disord. 2024 Dec 19;25(1):1027. doi: 10.1186/s12891-024-08143-0.
- Individual participant dataSharing planned: No
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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 PROM_R knee rehabilitation program in people with Lower Extremity Problem and Rehabilitation, run by University of Évora at 1 site in Portugal.
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 4 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: finished, as of the sponsor's last update on 3 Jun 2024. 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 Portugal. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health-related quality of life (time frame: Before the intervention, after 4-6 weeks and 6 months.). The study lists 3 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 NCT06206018, which also lists 5 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 3 Jun 2024.