An interventional study of Dual-Task Balance Training and Standard Rehabilitation in Lower Limb Amputation, Prosthesis Users and Balance Impairment, sponsored by Al-Azhar University - Gaza. Recruiting at 1 site in Palestinian Territories. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Al-Azhar University - Gaza · Not applicable, Interventional, and Treatment
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.
Lower-limb amputation can lead to significant impairments in balance, mobility, functional independence, and psychological well-being. Prosthesis users often experience challenges during walking and daily activities, particularly when they are required to perform a motor task and a cognitive task at the same time. Dual-task balance training is a rehabilitation approach that combines balance exercises with concurrent cognitive or motor tasks to improve postural control, mobility, attention, and functional performance.
This study is a parallel-group randomized controlled trial designed to investigate the effectiveness of dual-task balance training among traumatic lower-limb prosthesis users in the Gaza Strip. Eligible participants will be traumatic transtibial or transfemoral lower-limb prosthesis users who meet the study inclusion criteria and provide informed consent.
Participants will be randomly allocated into two groups. The experimental group will receive dual-task balance training in addition to standard rehabilitation. The control group will receive standard rehabilitation only. The dual-task balance training program will be conducted for 6 weeks, with three sessions per week. Training will include progressive balance activities combined with cognitive or motor secondary tasks, according to the participant's ability and safety level.
The primary outcomes of the study are balance and mobility, measured using the Berg Balance Scale and the Amputee Mobility Predictor with Prosthesis. The secondary outcome is mental health, measured using the Depression, Anxiety, and Stress Scale-21. Outcome measurements will be collected before and after the intervention period by an assessor who is not involved in delivering the intervention.
The study aims to provide evidence on whether adding dual-task balance training to standard rehabilitation can improve balance, mobility, and mental health outcomes among traumatic lower-limb prosthesis users in a resource-limited rehabilitation setting.
381 studies on the registry are indexed under Mobility Limitation; 108 are open to participants now.
This study's planned enrollment of 63 is above the median of 46 across 316 interventional studies indexed under Mobility Limitation.
Browse Mobility Limitation studies →Al-Azhar University - Gaza is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive dual-task balance training in addition to standard rehabilitation. The program will be delivered for 6 weeks, three sessions per week, and will include progressive balance exercises combined with cognitive or motor secondary tasks.
Behavioral: Dual-Task Balance Training · Behavioral: Standard Rehabilitation
Participants in this group will receive standard rehabilitation only, according to the usual rehabilitation program provided for lower-limb prosthesis users.
Behavioral: Standard Rehabilitation
A 6-week rehabilitation program consisting of progressive balance training combined with concurrent cognitive or motor tasks. Sessions will be conducted three times per week and will be adapted according to participant ability and safety level.
Usual rehabilitation care provided for lower-limb prosthesis users, including therapeutic exercises, gait training, balance activities, and functional mobility training according to the participant's clinical needs.
Change in Balance as Assessed by the Berg Balance Scale
Balance will be assessed using the Berg Balance Scale (BBS), which consists of 14 functional balance tasks. The total score ranges from 0 to 56, with higher scores indicating better balance performance. Change in balance will be calculated as the Week 6 score minus the baseline score.
Time frame: Baseline (Day 0) and Week 6
Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis
Mobility will be assessed using the Amputee Mobility Predictor with Prosthesis (AMPPro), which evaluates functional mobility in lower-limb prosthesis users through 21 mobility tasks. The total score ranges from 0 to 47, with higher scores indicating better functional mobility. Change in mobility will be calculated as the Week 6 score minus the baseline score.
Time frame: Baseline (Day 0) and Week 6
Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21
Mental health symptoms will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21), a 21-item self-report instrument comprising three subscales: depression, anxiety, and stress, with 7 items in each subscale. Each item is scored from 0 to 3. The item scores for each subscale are summed and multiplied by 2, resulting in a score range of 0 to 42 for each subscale. Higher scores indicate greater severity of depression, anxiety, or stress symptoms. Change in each subscale score will be calculated as the Week 6 score minus the baseline score.
Time frame: Baseline (Day 0) and Week 6
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality considerations, as the study includes sensitive health and mental health information. Only aggregated and anonymized study results will be reported.
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Al-Azhar University - Gaza