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- Essai clinique NCT07578792
Standard vs Dual-Task Hand-Arm Bimanual Training in Post-Stroke Patients
Comparative Effects of Standard and Dual Task Oriented Hand Arm Bimanual Intensive Training on Cognitive Performance, Upper Limb Functions and Coordination Among Post-Stroke Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Stroke is a leading cause of long-term disability, commonly resulting in deficits in upper limb function, coordination, and cognitive performance. These impairments significantly affect the ability to perform daily activities and reduce overall quality of life. Rehabilitation strategies that integrate both motor and cognitive components may enhance functional recovery and promote neuroplasticity.
Hand-Arm Bimanual Intensive Training (HABIT) is a task-specific, repetitive, and goal-oriented intervention designed to improve bilateral upper limb function through coordinated use of both hands. While standard HABIT has demonstrated effectiveness in improving motor outcomes, dual-task-oriented HABIT incorporates simultaneous cognitive demands, such as attention and problem-solving, to better simulate real-life functional activities.
This study is a randomized controlled trial designed to compare the effects of standard HABIT and dual-task-oriented HABIT on cognitive performance, upper limb motor function, and coordination among post-stroke patients. A total of 20 participants aged 40-70 years with mild to moderate upper limb impairment will be recruited. Participants will be randomly assigned to either the intervention group receiving a combination of standard and dual-task-oriented HABIT or the control group receiving standard HABIT only. The intervention will be delivered over eight weeks, with three sessions per week.
Outcome measures will include the Fugl-Meyer Assessment for upper limb function, Action Research Arm Test for functional performance, Finger-to-Nose test for coordination, and Montreal Cognitive Assessment for cognitive evaluation. Assessments will be conducted at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
The findings of this study will provide evidence on whether integrating cognitive challenges into bimanual training leads to superior rehabilitation outcomes, supporting more comprehensive and functionally relevant stroke rehabilitation strategies.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: ambreen iqbal, phD
- Numéro de téléphone: +923227616154
- E-mail: iqbalambreen8@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Wajeeha zia, phD
- Numéro de téléphone: +92323450078
- E-mail: wajeeha.zia@riphah.edu.pk
Lieux d'étude
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Punjab Province
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Narowal, Punjab Province, Pakistan
- Sahara Hospital
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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:
Both male and female' genders.
- Adults aged between 40 and 70 years.
- Clinically diagnosed ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI).
- Modified Ashworth Scale 1, 1+ and 2 will be included.
- Presence of mild to moderate upper limb motor impairment (as defined by Fugl Meyer Assessment score range 23-55 or clinical evaluation).
- Ability to comprehend and follow simple verbal instructions.
Exclusion Criteria:
Severe cognitive impairment or expressive/receptive aphasia limiting effective communication. (10)
- Other neurological disorders (e.g., Parkinson's disease) or psychiatric illnesses that could confound results.(11)
- Exclusion of patients with prior upper limb impairments (e.g., arthritis) unrelated to the recent stroke event.(10)
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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Comparateur actif: Standard HABIT
Participants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week.
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Participants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week.
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Expérimental: Dual-Task-Oriented HABIT
Participants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week.
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Participants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Upper Limb Motor Function
Délai: Baseline, Week 4, and Week 8
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Upper limb motor function will be assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UL), a validated scale evaluating motor recovery, movement control, and coordination in post-stroke patients.
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Baseline, Week 4, and Week 8
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Ambreen iqbal, phD, Riphah International University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- Muhammad Umar Butt
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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