Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users

Официальное название

Effectiveness of Dual-Task Balance Training on Balance, Mobility, and Mental Health Among Traumatic Lower-Limb Prosthesis Users in the Gaza Strip: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Dual-Task Balance Training
  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.
• Поведенческое Standard Rehabilitation
  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.

Первичные конечные точки

• Change in Balance as Assessed by the Berg Balance Scale [Срок оценки: Baseline (Day 0) and Week 6]
• Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis [Срок оценки: Baseline (Day 0) and Week 6]

Вторичные конечные точки (1)

• Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21 [Срок оценки: Baseline (Day 0) and Week 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Palestinian Territories · 1 центр

• Artificial Limb and Polio Centre — Gaza

Идентификаторы

NCT: NCT07706452 · AUG-LLA-DTBT-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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