Clinical Trial

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

Study acronym: PMR-AMP
Not Yet Recruiting
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Record status
This record was last updated August 24, 2025 (before its estimated November 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07139145
Lead Sponsor Marah Radi
Conditions Traumatic Lower Limb Amputation, Fatigue, Mobility Impairment, Psychological Stress
Enrollment 60 participants
Start Date 2025-09-15
Primary Completion 2025-11-15 (estimated)
Study Completion 2026-02-26 (estimated)
Updated on ClinicalTrials.gov 2025-08-24