Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis
10 de junio de 2026 actualizado por: Eman Kamal Abdelmoteleb, Cairo University
To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on:
- Strength of ankle muscles in children with hemiparesis.
- Balance in children with hemiparesis.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Children with hemiparetic cerebral palsy often favor their non-paretic side, leading to asymmetrical walking and balance issues.
Muscle weakness significantly restricts motor function, prompting a shift from spasticity management to strength training, which has a positive correlation with gross motor function and gait.
Task-oriented training has been shown to enhance balance.
Children with hemiparesis tend to prefer mobility equipment due to balance disturbances.
Functional electrical stimulation of ankle dorsiflexors combined with task-oriented training is being investigated for its effectiveness in improving balance in these children.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
36
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.
Estudio Contacto
- Nombre: Nourhan Reda Abdel Razek Dawood, physical therapist
- Número de teléfono: 01017173755
- Correo electrónico: Eman_pediatrics2016@yahoo.com
Ubicaciones de estudio
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Damietta, Egipto
- Reclutamiento
- Damietta general hospital.
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Contacto:
- Nourhan Reda Abdel Razek Dawood, physical therapist
- Número de teléfono: 01017173755
- Correo electrónico: Eman_pediatrics2016@yahoo.com
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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
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- The age of the selected children will be ranged from 6 to 9 years.
- Able to follow simple instructions.
- Degree of spasticity is ranging from 1to 1+ according to modified Ashworth scale.
- The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System.
Exclusion Criteria:
The children will be excluded if they have one or more of the following criteria:
- Visual, hearing disorders.
- Recent Botox injection or orthopedic surgery in the lower limb in the last 6 months before the start of the study.
- Any fixed deformity of 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 |
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Comparador activo: conventional exercise program
The control group consist of 18 children will receive conventional exercise program for 60 min.
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The program will run three days a week on non-consecutive days, focusing on various exercises for children.
Activities include: 1) knee manipulation for balance; 2) guided body weight shifting; 3) balancing on a board; 4) training for equilibrium and protective reactions; 5) gait training in a closed environment with obstacles; 6) open environment gait training; 7) strengthening exercises for the back, hips, and knees; and 8) passive stretching for tight muscles in both lower and upper limbs.
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Experimental: task-oriented training
Study group consist of 18 children will receive task-oriented training while applying the functional electrical stimulation on the affected lower limb for 20 min in addition to conventional exercise program for 40 min.
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The program will run three days a week on non-consecutive days, focusing on various exercises for children.
Activities include: 1) knee manipulation for balance; 2) guided body weight shifting; 3) balancing on a board; 4) training for equilibrium and protective reactions; 5) gait training in a closed environment with obstacles; 6) open environment gait training; 7) strengthening exercises for the back, hips, and knees; and 8) passive stretching for tight muscles in both lower and upper limbs.
1. Activities involve standing and reaching for objects at various distances and heights.
2. Sit-to-stand tasks are performed from different chair heights and while carrying objects.
3. Stepping activities occur in various directions and on different block heights and surfaces.
4. Alternating heel and toe raises focus on increasing repetitions.
5. Stairs are ascended and descended with added weight and object carrying.
6. Backward walking starts near a wall, progressing to shuttle runs.
7. Walking on a balance beam involves increased speed and varied surfaces.
The study will utilize Everyway Medical Instruments for electrical stimulation, with one electrode on the tibialis anterior muscle and the other on the common peroneal nerve.
A tilt sensor will trigger stimulation during the swing phase of the tibia.
The stimulation parameters include a pulse frequency of 25-40 hertz, a pulse duration of 250 to 300 milliseconds, and an on-off time ratio of 1:2 for 20 minutes, aimed at inducing ankle dorsiflexion while preventing inversion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of balance
Periodo de tiempo: at baseline and after 8 weeks
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Pediatric balance scale will be used to assess balance for all children participated in this study.
It contains 14-item.
Scoring for each item is scored 0 points (lowest function) to 4 points (highest function), with maximum score of 56 points.
Calculation of the total score by summation of the score of the 14 items
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at baseline and after 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of muscle strength
Periodo de tiempo: at baseline and after 8 weeks
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Each child will practice two trials per test to ensure familiarity.
Peak force values will be recorded using the handheld dynamometer after three trials for both break and method tests for each muscle group.
Standardized instructions will be provided, and encouragement will be given for maximal effort.
During the break test, force will increase progressively over one second to maximize muscle fiber activation.
Children will be shown test conduct prior to starting three trials.
For the tibialis anterior muscle test, children will lay on a plinth with legs restrained and push against a device with their foot.
Assessing ankle muscle groups, especially plantar flexors and dorsiflexors, is crucial for understanding power generation in walking and gait speed, particularly in stroke patients, while testing positions will be optimized for clinical feasibility.
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at baseline and after 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 abril de 2026
Finalización primaria (Actual)
5 de junio de 2026
Finalización del estudio (Estimado)
5 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Nourhan_Msc
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
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