TELE-REHABILITATION VERSUS CLINIC-BASED MODIFIED CONSTRAINT-INDUCED MOVEMENT THERAPY FOR UPPER LIMB FUNCTION IN CHRONIC STROKE PATIENTS (TELE-mCIMT)
Stroke commonly results in persistent upper limb impairment that limits functional independence and participation in daily activities. Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based intervention for improving upper limb function after stroke. Tele-rehabilitation has emerged as an alternative method of delivering rehabilitation services, potentially improving accessibility while maintaining treatment effectiveness.
This randomized controlled trial will compare the effectiveness of tele-rehabilitation-based mCIMT with clinic-based mCIMT in individuals with chronic stroke. Sixty-eight eligible participants will be randomly allocated into two groups. The tele-rehabilitation group will receive supervised mCIMT through virtual sessions combined with a structured home exercise program, while the clinic-based group will receive the same intervention in a clinical setting. Both groups will receive treatment three times per week for 6 weeks.
Upper limb function, spasticity, motor performance, and intrinsic motivation will be assessed at baseline and after the 6-week intervention using the Upper Extremity Fugl-Meyer Assessment (UEFMA), Modified Ashworth Scale (MAS), Wolf Motor Function Test (WMFT), and Intrinsic Motivation Inventory (IMI). The study aims to determine whether tele-rehabilitation is as effective as clinic-based mCIMT for improving upper limb function in individuals with chronic stroke.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study is a single-center, randomized controlled trial designed to compare the effectiveness of tele-rehabilitation-based modified Constraint-Induced Movement Therapy (mCIMT) with clinic-based mCIMT in individuals with chronic stroke. A total of 68 participants meeting the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and randomly allocated into two groups using the sealed envelope method. Outcome assessors will remain blinded to group allocation.
Participants in the tele-rehabilitation group will attend an initial in-person assessment followed by supervised virtual rehabilitation sessions. The intervention will include heat application, self-stretching, active-assisted range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy. Participants will perform functional upper limb activities while wearing a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Participants in the clinic-based group will receive the same rehabilitation components, including heat application, stretching, range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy, delivered face-to-face in the rehabilitation clinic. Treatment sessions will be conducted three times per week for 6 weeks, with home practice using the constraint mitt for 4 hours daily.
Outcome assessments will be performed at baseline and after completion of the 6-week intervention. The primary outcome measures will include upper limb motor function assessed using the Upper Extremity Fugl-Meyer Assessment (UEFMA) and spasticity assessed using the Modified Ashworth Scale (MAS). Secondary outcome measures will include the Wolf Motor Function Test (WMFT) and the Intrinsic Motivation Inventory (IMI). The study will evaluate whether tele-rehabilitation-based mCIMT provides comparable or superior improvements in upper limb function, motor performance, spasticity, and motivation compared with clinic-based mCIMT in individuals with chronic stroke.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Montiha Azeem, MSPTN
- Número de teléfono: 03479717317
- Correo electrónico: muntahaazeem9@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Kainat Tariq, MSPTN
- Número de teléfono: 03328256500
- Correo electrónico: kainattariq06@gmail.com
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
- Shadman Medical Center, Lahore
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Contacto:
- Montiha Azeem, MSPTN
- Número de teléfono: 03479717317
- Correo electrónico: muntahaazeem9@gmail.com
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Contacto:
- Kainat Tariq, MSPT N
- Número de teléfono: 03328256500
- Correo electrónico: kainattariq06@gmail.com
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Investigador principal:
- Kainat Tariq, MSPTN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participant with age from 35 to 75 years
- Both gender
- Patients after 6 month of stroke.
- Participant with flexion and abduction at shoulder minimum 10-15 degree and 5-10 degree at wrist and thumb/digit.
- Participants with access to a smartphone or laptop with internet connectivity and the ability to use it for tele-rehabilitation sessions.
- Participant with modified ashworth scale score of 2 or higher.
- Participants who have internet access and can also engage in video conferences.
Exclusion Criteria:
- Patient with any neurological issues apart from stroke that might impact motor function.
- Patient who is not able to follow the commands or are unable to cooperate.
- Patient with any autoimmune disorder like rheumatoid arthritis that might impact arm function.
- Patient with history of epilepsy. Participant who are involved in any fitness program that can improve upper extremity function.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation.
The intervention will include supervised virtual sessions consisting of heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities.
Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Treatment will be provided 3 sessions per week for 6 weeks.
|
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation.
The intervention will include supervised virtual sessions comprising heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities.
Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Treatment will be delivered 3 sessions per week for 6 weeks.
|
|
Comparador activo: group B Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting.
The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision.
Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and for 4 hours daily at home.
Treatment will be provided 3 sessions per week for 6 weeks.
|
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting.
The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision.
Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and continue constraint use for 4 hours daily at home.
Treatment will be delivered 3 sessions per week for 6 weeks.
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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 Extremity Fugl-Meyer Assessment (UEFMA)
Periodo de tiempo: Baseline and Week 6
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The Upper Extremity Fugl-Meyer Assessment (UEFMA) will be used to evaluate upper limb motor recovery.
Changes in UEFMA scores from baseline to the end of the 6-week intervention will be compared between the tele-rehabilitation and clinic-based modified Constraint-Induced Movement Therapy groups.
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Baseline and Week 6
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kainat Tariq, MSPTN, The University of Lahore, Lahore
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
Otros números de identificación del estudio
- UOL/IREB/25/09/0038
Información sobre medicamentos y dispositivos, documentos del estudio
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