This randomized controlled trial will evaluate the effectiveness of dual-task balance training on balance, mobility, and mental health among traumatic lower-limb prosthesis users in the Gaza Strip. Participants will be randomly assigned to either an experimental group receiving dual-task balance training in addition to standard rehabilitation or a control group receiving standard rehabilitation only. The intervention will be delivered over 6 weeks, with three sessions per week. Balance and mobility will be assessed using the Berg Balance Scale and the Amputee Mobility Predictor with Prosthesis, while mental health will be assessed using the Depression, Anxiety, and Stress Scale-21.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older.
* Traumatic unilateral lower-limb amputation.
* Transtibial or transfemoral amputation level.
* Current lower-limb prosthesis user.
* Able to stand and walk with the prosthesis, with or without an assistive device.
* Medically stable and able to participate in a rehabilitation training program.
* Able to understand and follow study instructions.
* Provides written informed consent.
Exclusion Criteria:
* Lower-limb amputation due to dysvascular, congenital, or non-traumatic causes.
* Bilateral lower-limb amputation.
* Severe cognitive impairment that prevents understanding or following study instructions.
* Severe visual, vestibular, neurological, or musculoskeletal condition that significantly affects balance or walking independent of the amputation.
* Unhealed residual limb wounds, severe pain, or skin problems that prevent safe prosthesis use.
* Uncontrolled medical condition that makes participation unsafe.
* Participation in another structured balance training program during the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Balance as Assessed by the Berg Balance Scale
Timeframe: Baseline (Day 0) and Week 6
2
Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis