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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

NCT07139145 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

  • Traumatic Lower Limb Amputation
  • Fatigue
  • Mobility Impairment
  • Psychological Stress

Interventions

BEHAVIORAL

Progressive Muscle Relaxation + Standard Physiotherapy

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

BEHAVIORAL

Standard Physiotherapy

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.

Sponsors & Collaborators

  • Marah Radi

    lead OTHER

Principal Investigators

  • Mosab Aldabbas, PhD · Al-Azhar University, Gaza Strip

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-11-15
Completion
2026-02-26

Countries

  • Palestinian Territories

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139145 on ClinicalTrials.gov