Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Hea… (NCT06206018) | Clinical Trial Compass
CompletedNot Applicable
Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care
Portugal65 participantsStarted 2023-09-10
Plain-language 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.
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — is there published data from it that you could share with me, and what did it suggest about whether tracking quality of life and anxiety scores actually improved outcomes for patients doing lower extremity rehabilitation?
2The trial measured things like anxiety, depression, and motivation to exercise alongside physical recovery — does that match how my own rehab program is currently being monitored, and should it be?
3Since this study looked specifically at knee injuries and lower extremity problems, how relevant do you think its findings are to my particular condition and the type of rehab I'd be doing?
4The trial used the Hospital Anxiety and Depression Scale as a key measure — given that mental health can affect physical recovery, is screening for anxiety and depression something we should be doing as part of my rehab plan?
5Based on what this trial was studying about patient-reported outcomes, are there questionnaires or self-reporting tools you'd recommend I use during my own rehabilitation to help guide my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-related quality of life
Timeframe: Before the intervention, after 4-6 weeks and 6 months.
2
Hospital Anxiety and Depression Scale
Timeframe: Before the intervention, after 4-6 weeks and 6 months.
3
Behavioural Regulations in Exercise Questionnaire
Timeframe: Before the intervention, after 4-6 weeks and 6 months.