Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users (DTBT-LLA)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rawan Nabil Alessi, MSc Student / BSc PT
- 電話番号：+972597288395
- メール：Rawan.n.elessi@hotmail.com
研究場所
-
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Gaza Strip
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Gaza、Gaza Strip、パレスチナの領土
- 募集
- Artificial Limb and Polio Centre
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dual-Task Balance Training Group
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.
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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.
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アクティブコンパレータ：Standard Rehabilitation Group
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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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Balance as Assessed by the Berg Balance Scale
時間枠：Baseline (Day 0) and Week 6
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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.
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Baseline (Day 0) and Week 6
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Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis
時間枠：Baseline (Day 0) and Week 6
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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.
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Baseline (Day 0) and Week 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21
時間枠：Baseline (Day 0) and Week 6
|
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.
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Baseline (Day 0) and Week 6
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AUG-LLA-DTBT-RCT-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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