NCT06206018: PROM_R

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

Completed NA Last updated 3 June 2024

What this trial tests

NA trial testing PROM_R knee rehabilitation program in Lower Extremity Problem in 65 participants. Completed in 31 May 2024.

Timeline

10 September 2023

Primary endpoint
1 March 2024

31 May 2024

Quick facts

Lead sponsor	University of Évora
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	10 September 2023
Primary completion	1 March 2024
Estimated completion	31 May 2024
Sites	1 location across Portugal

Drugs / interventions tested

• PROM_R knee rehabilitation program

Conditions studied

• Lower Extremity Problem — all drugs for Lower Extremity Problem →
• Rehabilitation — all drugs for Rehabilitation →
• Knee Injuries — all drugs for Knee Injuries →

Sponsor

University of Évora

Who can join

Adults 18 to 80, any sex, with Lower Extremity Problem or Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient-reported outcome measures in knee injuries rehabilitation: A protocol for intervention.
   Moreira J, Mesquita M, Flamínio J, de Almeida M, et al · · 2024 · cited 3× · PMID 38660046 · DOI 10.1016/j.mex.2024.102647
2. Health-related quality of life after rehabilitation from knee surgery in rural and urban settings: a quasi-experimental study.
   Moreira J, João A, Aguiar P, Raimundo A, et al · · 2024 · PMID 39702069 · DOI 10.1186/s12891-024-08143-0