Traumatic Lower Limb AmputationPMR-AMPNCT07139145
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
A study testing Progressive Muscle Relaxation + Standard Physiotherapy and Standard Physiotherapy in people with Traumatic Lower Limb Amputation and Fatigue, run by Marah Radi at 1 site in Palestinian Territories.
Trial summary
Lower limb amputation is a life-altering condition with profound physical and psychological consequences, including fatigue, impaired mobility, stress, and asymmetrical weight-bearing. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Traumatic Lower Limb Amputation, Fatigue, Mobility Impairment
- What is being tested?
- Progressive Muscle Relaxation + Standard Physiotherapy and Standard Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Sep 2025to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 59 years.
- Unilateral traumatic trans-femoral/transtibial amputation.
- Post prosthetic fitting.
Who cannot join
- Severe comorbidities (e.g., uncontrolled cardiovascular disease).
- Severe cognitive impairment or mental illness.
- Recent orthopaedic surgery (<3 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Palestinian Territories1 site
Artificial Limb & Polio Center (ALPC), Gaza
Gaza
Marah Nayef Radi, MSc, +972597235445, m.radi@hi.org
Mosab Aldabbas, PhD, +972562563022, mosab.m.aldabbas@gmail.com
About this study
Official title: Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Traumatic Lower Limb Amputees in Gaza Strip
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Progressive Muscle Relaxation + Standard Physiotherapy, Standard Physiotherapy
- Keywords
- Progressive Muscle Relaxation (PMR), Physiotherapy, Rehabilitation, Fatigue, Mobility, Stress, Weight-Bearing Symmetry, Gaza Strip, Amputees, Randomized Controlled Trial (RCT)
- Medical subject headings
- Fatigue, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation + Standard PhysiotherapyBehavioural
Standard physiotherapy exercises plus PMR sessions. PMR is gradually transitioned from therapist-guided to self-directed practice across the 6 weeks.
Standard PhysiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Level
Assessed using the Fatigue Scale-2, measuring perceived physical and mental fatigue. Scores quantify fatigue severity.
Measured: 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.
Measured: Baseline, 6 weeks post-intervention and 8 weeks Follow up
Stress Level
Assessed with a validated Perceived Stress Scale measuring psychological stress
Measured: 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.
Measured: Baseline, 6 weeks post-intervention and 8 weeks following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marah Radi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marah Radi, Al-Azhar University
- Investigators
- Mosab Aldabbas, PhD, Study chair, Al-Azhar University, Gaza Strip
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139145
- Sponsor's protocol ID
- PHRC/HC/1251/25
- Acronym
- PMR-AMP
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared. Data will be kept confidential and used solely for the purposes of this study
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Traumatic Lower Limb Amputees in Gaza Strip
- ClinicalTrials.gov ID
- NCT07139145
- Acronym / sponsor ID
- PMR-AMP / PHRC/HC/1251/25
- Keywords
- Progressive Muscle Relaxation (PMR), Physiotherapy, Rehabilitation, Fatigue, Mobility, Stress, Weight-Bearing Symmetry, Gaza Strip
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marah RadiUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental - Physiotherapy + Progressive Muscle Relaxation (PMR) | Experimental | Behavioral: Progressive Muscle Relaxation + Standard PhysiotherapyParticipants 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. |
| Active Comparator - Standard Physiotherapy Only | Active comparator | Behavioral: Standard PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 59 years.
- Unilateral traumatic trans-femoral/transtibial amputation.
- Post prosthetic fitting.
Key exclusion criteria (3 listed)
- Severe comorbidities (e.g., uncontrolled cardiovascular disease).
- Severe cognitive impairment or mental illness.
- Recent orthopaedic surgery (<3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation + Standard PhysiotherapyStandard physiotherapy exercises plus PMR sessions. PMR is gradually transitioned from therapist-guided to self-directed practice across the 6 weeks. | Behavioural | Experimental - Physiotherapy + Progressive Muscle Relaxation (PMR) |
| Standard PhysiotherapyParticipants 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. | Behavioural | Active Comparator - Standard Physiotherapy Only |
Primary outcome
Fatigue Level
Time frame: 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.
Mobility
Time frame: Baseline, 6 weeks post-intervention and 8 weeks Follow up
Measured using the 2-Minute Walk Test (2MWT) to assess distance walked in meters.
Stress Level
Time frame: Baseline, 6 weeks post-intervention and 8 weeks following
Assessed with a validated Perceived Stress Scale measuring psychological stress
Weight-Bearing distribution
Time frame: Baseline, 6 weeks post-intervention and 8 weeks following
Measured using a dual bathroom scale during standing tasks to assess weight-bearing capacity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No. individual participant data will not be shared. Data will be kept confidential and used solely for the purposes of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mosab Aldabbas, PhD study chair
Al-Azhar University, Gaza Strip
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation + Standard Physiotherapy and Standard Physiotherapy in people with Traumatic Lower Limb Amputation and Fatigue, run by Marah Radi at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marah Nayef Radi, MSc (+972597235445, m.radi@hi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Level (time frame: Baseline, 6 weeks post-intervention and 8 weeks follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.