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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Progressive Muscle Relaxation + Standard Physiotherapy
BehavioralStandard physiotherapy exercises plus PMR sessions. PMR is gradually transitioned from therapist-guided to self-directed practice across the 6 weeks.
Standard Physiotherapy
BehavioralParticipants 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
Trial outcomes
Primary outcomes
Fatigue Level
Assessed using the Fatigue Scale-2, measuring perceived physical and mental fatigue. Scores quantify fatigue severity.
Mobility
Measured using the 2-Minute Walk Test (2MWT) to assess distance walked in meters.
Stress Level
Assessed with a validated Perceived Stress Scale measuring psychological stress
Weight-Bearing distribution
Measured using a dual bathroom scale during standing tasks to assess weight-bearing capacity.
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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