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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-02-26

Brief Summary

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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.

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Detailed Description

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This study protocol addresses the multidimensional challenges faced by individuals with traumatic lower limb amputation in the Gaza Strip, a conflict-affected region with limited access to rehabilitation. Amputees often experience persistent fatigue, impaired mobility, asymmetrical weight-bearing, and high psychological distress. Standard physical therapy primarily focuses on physical recovery, while psychosocial rehabilitation is often overlooked.

Rationale:

Progressive Muscle Relaxation (PMR) is a structured mind-body technique that systematically tenses and relaxes muscle groups to reduce stress and physical tension. Evidence from other populations, including patients with cancer, chronic illnesses, and stroke, has shown PMR to be effective in reducing fatigue, anxiety, stress, and improving functional performance. However, its use in amputee rehabilitation-particularly in conflict settings-remains underexplored.

Study Objectives:

General Objective: To evaluate the effect of integrating PMR with physiotherapy program on Fatigue, mobility, weightbearing distribution and stress among individuals with traumatic lower limb amputation.

Study Design:

Randomized controlled trial (RCT) with 60 participants allocated to intervention (PMR + physiotherapy) or control (physiotherapy alone) groups using block randomization and concealed allocation.

Outcome Measures:

Fatigue (FSS), mobility (2MWT), Stress (PSS-10), weight-bearing symmetry (dual scale method).

Assessment Timeline: Baseline (week 0), post-intervention (week 6), and follow-up (week 8).

Sample Size: 60 participants (30 per group), based on power analysis accounting for attrition.

Data Analysis: Descriptive statistics, paired t-tests, independent t-tests, and repeated-measures ANOVA. Intention-to-treat analysis will be applied.

Ethics: Approval is obtained from the Helsinki Committee and the Artificial Limbs and Polio Center (ALPC). Informed consent will be secured, confidentiality maintained, and adverse events monitored.

Expected Impact:

This study will provide the first randomized evidence on the effectiveness of PMR in traumatic amputee rehabilitation within Gaza. It is expected that adding PMR to physiotherapy will significantly reduce fatigue and stress, improve mobility, and enhance weight-bearing symmetry compared to physiotherapy alone. Results will inform rehabilitation protocols in low-resource, conflict-affected settings and may guide future policy and practice for amputee care.

Conditions

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Traumatic Lower Limb Amputation Fatigue Mobility Impairment Psychological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental - Physiotherapy + Progressive Muscle Relaxation (PMR)

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.

Group Type EXPERIMENTAL

Progressive Muscle Relaxation + Standard Physiotherapy

Intervention Type BEHAVIORAL

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

Active Comparator - Standard Physiotherapy Only

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.

Group Type ACTIVE_COMPARATOR

Standard Physiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No