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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rawan Nabil Alessi, MSc Student / BSc PT
- Numéro de téléphone: +972597288395
- E-mail: Rawan.n.elessi@hotmail.com
Lieux d'étude
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Gaza Strip
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Gaza, Gaza Strip, Territoires palestiniens
- Recrutement
- Artificial Limb and Polio Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Balance as Assessed by the Berg Balance Scale
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21
Délai: Baseline (Day 0) and Week 6
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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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AUG-LLA-DTBT-RCT-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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