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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-Task Balance Training Group | Experimental | 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. |
|
| Standard Rehabilitation Group | Active Comparator | Participants in this group will receive standard rehabilitation only, according to the usual rehabilitation program provided for lower-limb prosthesis users. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-Task Balance Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance as Assessed by the Berg Balance Scale | Balance will be assessed using the Berg Balance Scale. The scale includes 14 functional balance tasks, with higher scores indicating better balance performance. | Baseline and after 6 weeks of intervention |
| Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis | Mobility will be assessed using the Amputee Mobility Predictor with Prosthesis. The tool evaluates functional mobility among lower-limb prosthesis users, with higher scores indicating better mobility performance. | Baseline and after 6 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mental Health as Assessed by the Depression, Anxiety, and Stress Scale-21 | Mental health symptoms will be assessed using the Depression, Anxiety, and Stress Scale-21, which measures depression, anxiety, and stress symptoms. Higher scores indicate greater symptom severity. | Baseline and after 6 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rawan Nabil Alessi, MSc Student / BSc PT | Contact | +972597288395 | Rawan.n.elessi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artificial Limb and Polio Centre | Recruiting | Gaza | Gaza Strip | Palestinian Territories |
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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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D000673 | Amputation, Traumatic |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D010549 | Personal Satisfaction |
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Participants will be randomly assigned into two parallel groups. The experimental group will receive dual-task balance training in addition to standard rehabilitation, while the control group will receive standard rehabilitation only. Outcomes will be measured before and after the 6-week intervention period.
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The outcomes assessor will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the rehabilitation intervention.
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| Standard Rehabilitation | Behavioral | 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. |
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| D001519 | Behavior |