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 | Not Yet Recruiting

• 1 other identifier: PHRC/HC/1251/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Progressive Muscle Relaxation (PMR); Physiotherapy; Rehabilitation; Fatigue; Mobility; Stress; Weight-Bearing Symmetry; Gaza Strip; Amputees; Randomized Controlled Trial (RCT)

Outcome Measures

Primary Outcomes (4)

• Fatigue Level

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

  Baseline, 6 weeks post-intervention and 8 weeks follow up

• Mobility

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

  Baseline, 6 weeks post-intervention and 8 weeks Follow up

• Stress Level

  Assessed with a validated Perceived Stress Scale measuring psychological stress

  Baseline, 6 weeks post-intervention and 8 weeks following

• Weight-Bearing distribution

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

  Baseline, 6 weeks post-intervention and 8 weeks following

Study Arms (2)

Experimental - Physiotherapy + Progressive Muscle Relaxation (PMR)

EXPERIMENTAL

Participants receive a 6-week standard physiotherapy program combined with Progressive Muscle Relaxation (PMR). Physiotherapy includes warm-up, weight-bearing training, balance training, gait training, and functional activities, delivered twice weekly. PMR sessions last 20 minutes, twice weekly, and involve systematic tensing/relaxing of major muscle groups, diaphragmatic breathing, and visualization techniques adapted for amputees.

Behavioral: Progressive Muscle Relaxation + Standard Physiotherapy

Active Comparator - Standard Physiotherapy Only

ACTIVE COMPARATOR

Participants receive the same 6-week standard physiotherapy program as the intervention group (warm-up, weight-bearing training, balance training, gait training, and functional activities, twice weekly) but without Progressive Muscle Relaxation.

Behavioral: Standard Physiotherapy

Interventions

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.

Experimental - Physiotherapy + Progressive Muscle Relaxation (PMR)

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.

Active Comparator - Standard Physiotherapy Only

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 59 years.
• Unilateral traumatic trans-femoral/transtibial amputation.
• Post prosthetic fitting.

You may not qualify if:

• Severe comorbidities (e.g., uncontrolled cardiovascular disease).
• Severe cognitive impairment or mental illness.
• Recent orthopaedic surgery (\<3 months)

Sponsors & Collaborators

• Marah Radi: lead

Study Sites (1)

Artificial Limb & Polio Center (ALPC), Gaza

Gaza, Palestinian Territories

Location

MeSH Terms

Conditions

Fatigue; Stress, Psychological

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mosab Aldabbas, PhD

  Al-Azhar University, Gaza Strip

  STUDY CHAIR

Central Study Contacts

Marah Nayef Radi, MSc

CONTACT

+972597235445; m.radi@hi.org

Mosab Aldabbas, PhD

CONTACT

+972562563022; mosab.m.aldabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Student, Faculty of Applied Medical Sciences, Al-Azhar University - Gaza

Model Details: Participants will be randomly allocated in a 1:1 ratio to either an intervention group (standard physiotherapy plus Progressive Muscle Relaxation) or a control group (standard physiotherapy alone). The trial will follow a parallel-group design, with outcomes assessed at baseline, post-intervention (6 weeks), and follow-up (8 weeks).

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: September 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: February 26, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)