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Completed

NCT Number: NCT06206018

Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care

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.

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Key information

Conditions

Lower Extremity Problem Knee Injuries Leg Injuries Rehabilitation Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National School of Public Health

Lisbon, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROM_R knee rehabilitation program

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Évora

Other

Registry information

Acronym: PROM_R

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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