Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Traumatic Lower Limb Amputees in Gaza Strip
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fatigue Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 59 years.
- •Unilateral traumatic trans-femoral/transtibial amputation.
- •Post prosthetic fitting.
排除标准
- •Severe comorbidities (e.g., uncontrolled cardiovascular disease).
- •Severe cognitive impairment or mental illness.
- •Recent orthopaedic surgery (<3 months)
研究组 & 干预措施
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.
干预措施: Progressive Muscle Relaxation + Standard Physiotherapy (Behavioral)
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.
干预措施: Standard Physiotherapy (Behavioral)
结局指标
主要结局
Fatigue Level
时间窗: Baseline, 6 weeks post-intervention and 8 weeks follow up
Assessed using the Fatigue Scale-2, measuring perceived physical and mental fatigue. Scores quantify fatigue severity.
Stress Level
时间窗: Baseline, 6 weeks post-intervention and 8 weeks following
Assessed with a validated Perceived Stress Scale measuring psychological stress
Mobility
时间窗: Baseline, 6 weeks post-intervention and 8 weeks Follow up
Measured using the 2-Minute Walk Test (2MWT) to assess distance walked in meters.
Weight-Bearing distribution
时间窗: Baseline, 6 weeks post-intervention and 8 weeks following
Measured using a dual bathroom scale during standing tasks to assess weight-bearing capacity.
次要结局
未报告次要终点
研究者
Marah Radi
Master's Student, Faculty of Applied Medical Sciences, Al-Azhar University - Gaza
Al-Azhar University