Functional Electrical Stimulation Versus Whole-Body Vibration in Post-Stroke Rehabilitation
1 de junio de 2026 actualizado por: Riphah International University
Comparative Effects of Functional Electrical Stimulation and Whole Body Vibration Training on Lower Limb Motor Control, Balance and Physical Performance in Post-Stroke Patients
This study will compare the effects of Functional Electrical Stimulation (FES) and Whole Body Vibration Training (WBVT) on lower limb motor control, balance, and physical performance in post-stroke patients.
It will be a single-blinded randomized clinical trial including 34 participants, who will be allocated into two groups.
Both groups will receive their respective interventions 4 days per week for 8 weeks.
Outcomes will be assessed at baseline and after 8 weeks using the Fugl-Meyer Assessment for lower extremity motor control, Berg Balance Scale for balance, and Barthel Index for physical performance.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke is an acute focal injury of the central nervous system caused by a vascular source, which results in neurological deficits and can cause disability or death.
Stroke can lead to motor weakness, sensory deficiency and loss of motor control.
Patients who have had a stroke frequently experience issues with their balance, gait and physical performance.
Whole-Body Vibration Training (WBVT) is a non-pharmacological intervention that transmits vibration stimulation throughout the body and has demonstrated promise in improving balance, mobility, and physical function in stroke rehabilitation.
Functional Electrical Stimulation (FES) is a rehabilitation technique that helps stroke survivors regain motor skills by stimulating certain nerves with electrical impulses applied via the skin's surface, which causes paretic muscles to move.
FES can be utilized to improve physical performance, muscle strength, and balance in stroke patients.
Strokes frequently lead to poor physical performance, diminished balance, and impaired lower limb motor control, all of which have an adverse effect on daily functioning and quality of life.
This study aims to compare the effects of Functional Electrical Stimulation and Whole Body Vibration Training on lower limb motor control, balance, and physical performance in post-stroke patients.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
34
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Punjab Province
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Gujrat, Punjab Province, Pakistán, 50700
- Hafiz Physiotherapy Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- the patient is between the ages of 35 and 70.
- Both male and female participants will be included.
- Chronic post-stroke patients from 6 months to 1 year.
- Stroke patients who have a neurological impairment.
- Individuals who experienced a single stroke in either the left or right hemisphere of the brain.
- Lower limb motor impairment with Fugl-Meyer Lower Extremity Score ≤ 28.
- Barthel Index Score ≥ 60.
- Berg Balance Scale Score ≥ 21.
Exclusion Criteria:
patients suffering from unstable cardiac condition, severe hypertension, congestive heart failure, aphasia, or cognitive impairments for which exercises are contraindicated.
- Patients with recurrent stroke.
- Patients undergoing other form of lower limb stimulation therapy concurrently.
- Severe orthopedic conditions or joint deformities affecting lower limb.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: Functional Electrical Stimulation Group
Participants in this arm will receive transcutaneous Functional Electrical Stimulation for lower limb rehabilitation for 8 weeks.
Stimulation will be applied to selected lower limb muscles including tibialis anterior, quadriceps, hamstrings, and peroneal muscles.
Treatment parameters will progress according to tolerance, including intensity, session duration, and functional movement integration.
Outcomes will be assessed at baseline and after 8 weeks.
|
Functional Electrical Stimulation will be delivered transcutaneously to selected lower limb muscles for 8 weeks.
Stimulation will target tibialis anterior, quadriceps, hamstrings, peroneal muscles, and other lower limb muscles according to patient need and tolerance.
The intervention will use biphasic symmetrical pulsed current with progressive intensity, duration, and functional movement integration.
Treatment will be supervised by a physiotherapist, and outcomes will be assessed at baseline and after 8 weeks.
Otros nombres:
|
|
Comparador activo: Whole Body Vibration Training Group
Participants in this arm will receive Whole Body Vibration Training using a vibration platform for 8 weeks. Training will include progressive activities such as standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance. Vibration frequency, duration, and exercise difficulty will be gradually progressed according to tolerance. Outcomes will be assessed at baseline and after 8 weeks. After this, go to Interventions and add Functional Electrical Stimulation and Whole Body Vibration Training, then assign each intervention to its matching arm. |
Whole Body Vibration Training will be delivered using a vibration platform for 8 weeks.
Participants will perform progressive lower limb activities including standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance exercises.
Frequency, duration, and difficulty will be progressed according to patient tolerance under physiotherapist supervision.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
lower Limb Motor Control
Periodo de tiempo: Baseline and 8 weeks post-intervention
|
Assessed using the Fugl-Meyer Assessment for Lower Extremity.
|
Baseline and 8 weeks post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Balance
Periodo de tiempo: Baseline and 8 weeks post-intervention
|
Assessed using the Berg Balance Scale.
|
Baseline and 8 weeks post-intervention
|
|
Physical Performance
Periodo de tiempo: Baseline and 8 weeks post-intervention
|
Assessed using the Barthel Index Scale.
|
Baseline and 8 weeks post-intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Ambreen Iqbal IQBAL, Riphah International University Role
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de junio de 2025
Finalización primaria (Estimado)
6 de julio de 2026
Finalización del estudio (Estimado)
6 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NOOR NAZISH
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The individual participant data sharing plan has not yet been finalized.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .