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

University of Évora

Status: Completed

Conditions: Knee Injuries; Rehabilitation; Lower Extremity Problem

Treatments: Procedure: PROM_R knee rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT06206018

CE-ENSP 3/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

PROM_R Knee

Experimental group

Description:

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.

Treatment:

Procedure: PROM_R knee rehabilitation program

Crontrol Group

No Intervention group

Description:

The control group will follow a standard six-week rehabilitation program.