- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ambreen iqbal, phD
- Número de teléfono: +923227616154
- Correo electrónico: iqbalambreen8@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Wajeeha zia, phD
- Número de teléfono: +92323450078
- Correo electrónico: wajeeha.zia@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Narowal, Punjab Province, Pakistán
- Sahara Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Upper Limb Motor Function
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Ambreen iqbal, phD, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Muhammad Umar Butt
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Standard HABIT
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Université Catholique de LouvainReclutamiento
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Université Catholique de LouvainTerminadoParálisis cerebralBélgica
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Universidad Europea de MadridAún no reclutando
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University Hospital of Mont-GodinneUniversité Catholique de LouvainDesconocidoHemiplejía congénitaBélgica
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Université Catholique de LouvainReclutamiento
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Tel Aviv UniversityReclutamiento
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Taipei Medical University Shuang Ho HospitalTerminadoCuidadores de niños pequeños que reciben intervención tempranaTaiwán
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Samsung Medical CenterTerminadoParálisis cerebralCorea del Sur
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University of OxfordTerminado
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Medical University of South CarolinaIcahn School of Medicine at Mount SinaiTerminadoAccidente Cerebrovascular IsquémicoEstados Unidos