Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Individuals With Traumatic Lower Limb Amputation in the Gaza Strip

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorMarah Radi

About this trial

Lower limb amputation is a life-altering condition with profound physical and psychological consequences, including fatigue, impaired mobility, stress, and asymmetrical weight-bearing. These challenges are particularly severe in conflict-affected settings like the Gaza Strip, where access to rehabilitation services is limited.

This study aims to evaluates the effect of adding Progressive Muscle Relaxation (PMR), a simple and cost-effective relaxation technique, to standard physical therapy on Fatigue, mobility, weightbearing distribution and stress outcomes among adults with unilateral traumatic lower limb amputation in Gaza.

Study design:

RCT with 60 participants will be randomly assigned to either (1) a control group receiving standard physiotherapy or (2) an intervention group receiving standard physiotherapy plus PMR.

Outcomes will be measured using validated instruments: Fatigue Severity Scale (FSS), 2-Minute Walk Test (2MWT), Perceived Stress Scale (PSS-10), and dual bathroom scale method for weight-bearing distribution. Assessments will be conducted at baseline, post-intervention (6 weeks), and follow-up (8 weeks).

The study aims to determine whether integrating PMR into rehabilitation improves fatigue reduction, functional mobility, stress management, and weight-bearing symmetry compared to physiotherapy alone. Findings will contribute to evidence-based rehabilitation strategies for amputees in low-resource, high-stress environments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 59 years.

Unilateral traumatic trans-femoral/transtibial amputation.

Post prosthetic fitting.

Disqualifiers

Severe comorbidities (e.g., uncontrolled cardiovascular disease).

Severe cognitive impairment or mental illness.

Recent orthopaedic surgery (<3 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progressive Muscle Relaxation + Standard Physiotherapy

    Behavioral

    Standard physiotherapy exercises plus PMR sessions. PMR is gradually transitioned from therapist-guided to self-directed practice across the 6 weeks.

  • Standard Physiotherapy

    Behavioral

    Participants receive a 6-week standard physiotherapy program delivered twice weekly. Sessions include warm-up, weight-bearing training, balance exercises, gait training, and functional activities. The protocol focuses on improving mobility, weight-bearing capacity, balance, and functional independence. No Progressive Muscle Relaxation or additional behavioral techniques are included.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental - Physiotherapy + Progressive Muscle Relaxation (PMR)Experimental treatment 1 intervention
Group B: Active Comparator - Standard Physiotherapy OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fatigue Level

Assessed using the Fatigue Scale-2, measuring perceived physical and mental fatigue. Scores quantify fatigue severity.

Time frame
Baseline, 6 weeks post-intervention and 8 weeks follow up
2

Mobility

Measured using the 2-Minute Walk Test (2MWT) to assess distance walked in meters.

Time frame
Baseline, 6 weeks post-intervention and 8 weeks Follow up
3

Stress Level

Assessed with a validated Perceived Stress Scale measuring psychological stress

Time frame
Baseline, 6 weeks post-intervention and 8 weeks following
4

Weight-Bearing distribution

Measured using a dual bathroom scale during standing tasks to assess weight-bearing capacity.

Time frame
Baseline, 6 weeks post-intervention and 8 weeks following

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marah Radi

Lead sponsor

Al-Azhar University

Sponsor institution

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