Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia
10 de junio de 2026 actualizado por: Eman Kamal Abdelmoteleb, Cairo University
This study was done to investigate the effect of blood flow restriction in the lower limbs on:
Strength of the quadriceps muscle, quadriceps muscle architecture (muscle thickness and pennation angle between muscle fibres), selective motor control of the lower limb in the affected limb, and gait parameters.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Current clinical practice for managing children with cerebral palsy employs various treatments rather than a single approach.
Blood flow restriction training, using pneumatic tourniquets to restrict blood flow to limbs, results in hypoxia and increased intramuscular pressure during contractions.
Although research on blood flow restriction has expanded, many practitioners lack clarity on its application and safety.
Evidence indicates that Blood flow restriction resistance exercise enhances muscle strength and hypertrophy more effectively than low-load resistance exercise alone.
This study suggests a multimodal treatment combining Blood flow restriction and strength training could expedite rehabilitation, particularly for children with hemiplegia.
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
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
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Al Mansurah, Egipto
- outpatient clinics of General Hospitals in Dakahlia governorate.
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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:
- Hemiplegic cerebral palsied children.
- The children age will be ranges from 3-8 years chronologically.
- The children will have degree of spasticity ranged from 1 to 2 on Modified Ashworth Scale
- The children will have Level I according to the Gross Motor Function Classification System.
- All children will be able to follow instructions.
Exclusion Criteria:
children were excluded from the study if they have any problems of the following:
- Cognitive dysfunction.
- Recent nonunion fracture.
- Fixed contractures and deformities.
- Previous surgery and Impaired circulation of that lower limb.
- Received Botulinum toxin A injections in the last six months.
- Children suffers from Peripheral Arterial and venous Diseases in the hemiplegic limb.
- Children suffering from uncontrolled convulsions.
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: selected physical therapy program
Children in the control group will receive the selected physical therapy (PT) program one hour three times weekly for eight successive weeks
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The physical therapy program includes passive stretching exercises for the lower limb to enhance range of motion (ROM) in children with cerebral palsy (CP), transition training from sitting to standing to improve postural control, and core stability exercises to boost trunk endurance and gait.
Reactive balance training aims to improve children's postural response organization, while various walking training methods, including treadmill and obstacle walking, focus on enhancing gait speed, balance, and postural stability.
Overall, the program is designed to address specific impairments and activity limitations in children with hemiplegic CP.
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Experimental: selected physical therapy program and Blood Flow Restriction
This group will receive the selected physical therapy program as group (A) in addition to blood flow restriction on the upper thigh.
Training Frequency will be one hour for 2-3 times a week for 8 weeks
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The physical therapy program includes passive stretching exercises for the lower limb to enhance range of motion (ROM) in children with cerebral palsy (CP), transition training from sitting to standing to improve postural control, and core stability exercises to boost trunk endurance and gait.
Reactive balance training aims to improve children's postural response organization, while various walking training methods, including treadmill and obstacle walking, focus on enhancing gait speed, balance, and postural stability.
Overall, the program is designed to address specific impairments and activity limitations in children with hemiplegic CP.
This group will undergo a physical therapy program incorporating Blood Flow Restriction therapy on the upper thigh.
The training will consist of one hour sessions, 2-3 times a week for 8 weeks.
The load applied will be 20-40% of One-repetition maximum (1RM), with 5-10 minutes of restriction time per exercise set.
Each session will include 4 sets, totaling 75 repetitions (30 × 15 × 15 × 15), along with reperfusion between sets.
Pressure application will be 40-80% of arterial occlusion pressure (AOP), with rest periods of 30-60 seconds between sets.
The restriction form will be continuous, with an execution speed of 1-2 seconds for each exercise, continuing until the planned repetitions are completed.
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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 muscle architecture
Periodo de tiempo: at baseline and after 8 weeks
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One method to evaluate muscle function and morphology is through skeletal muscle architecture analysis, which examines the geometric arrangement of muscle fibers using non-invasive ultrasound techniques.
Key parameters include muscle thickness, which correlates with strength, and pennation angle, which affects force transmission to tendons.
Measurements are conducted with participants supine, allowing stabilization, and involve high-quality ultrasound imaging (B-mode) for consistent results.
An experienced researcher measures muscle thickness and pennation angle using standardized protocols and software for analysis, ensuring accuracy across assessments.
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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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The isometric strength of knee extensor muscles will be measured using a handheld dynamometer, with a standardized position.
A 'make' test will require participants to exert maximum effort against a constant resistance for 3 to 5 seconds.
Children will be positioned with the dynamometer on the anterior tibia, while seated with knees and hips flexed at 90 degrees.
Each child will have two practice trials before performing three trials, receiving strong encouragement to maximize force output, which will be recorded.
If a participant cannot effectively isolate the muscle group or generate sufficient force, a zero score will be noted.
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at baseline and after 8 weeks
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Assessment of selective motor control
Periodo de tiempo: at baseline and after 8 weeks
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The Scale evaluates five reciprocal lower extremity movements: hip flexion-extension, knee flexion-extension, ankle dorsiflexion-plantar flexion, subtalar inversion-eversion, and toe flexion/extension.
The hip test is performed in a side-lying position, while the others are conducted in a seated position.
Each movement is passively executed by the tester using a three-second verbal cadence.
Each limb is assessed separately, focusing on selective joint movement and avoiding extraneous motions.
Movements are scored on a scale of 0-2: 2 (Normal) for complete movements within the cadence, 1 (Impaired) for partial isolated movements or deviations, and 0 (Unable) for lack of movement initiation.
The total score per limb can reach a maximum of 10.
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at baseline and after 8 weeks
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Assessment of gait
Periodo de tiempo: at baseline and after 8 weeks
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The observational gait scale will be used to analyze typical walk viewed on split-screen video in slow motion.
The children will be instructed to walk, and videos will be taken from the side.
Children will be videotaped, six sections will be tested to evaluate knee and ankle kinematics (Knee position in mid stance, Initial foot contact, Foot contact at mid stance, Base of support, Gait assistive devices, degree of change) with a total score of 22 on each limb.
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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 octubre de 2025
Finalización primaria (Actual)
1 de diciembre de 2025
Finalización del estudio (Actual)
20 de diciembre de 2025
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
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Parálisis
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Hemiplejía
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia de restricción de flujo sanguíneo
Otros números de identificación del estudio
- Ibrahim-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
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 the selected physical therapy program
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Children's HealthTerminadoDesorden del espectro autistaEstados Unidos