Effect of Plyometric Training Cross Education on Strength, Selective Motor Control and Balance in Children With Hemiplegic Cerebral Palsy (PLYO-HCP)
The goal of this clinical trial is to evaluate the effect of plyometric training with cross-education on lower limb muscle strength, selective motor control, and balance in children with hemiplegic cerebral palsy (HCP). It will also assess the safety and feasibility of applying this training program in pediatric rehabilitation.
The main questions it aims to answer are:
Does plyometric training with cross-education improve lower limb muscle strength in children with HCP? Does it improve selective motor control in the affected lower limb? Does it improve balance in children with HCP? Researchers will compare a study group receiving conventional physiotherapy plus plyometric training applied to the less affected limb to a control group receiving conventional physiotherapy only.
Participants will:
Receive treatment for 12 weeks (2 sessions per week) Attend regular physiotherapy sessions including stretching, strengthening, balance, and gait training Participate in plyometric exercises (study group only) Be assessed before and after the intervention using standardized tests for muscle strength, selective motor control, and balance
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will be conducted as a randomized controlled clinical trial to investigate the effect of unilateral plyometric training with cross-education on lower limb muscle strength, selective motor control, and balance in children with hemiplegic cerebral palsy (HCP).
Hemiplegic cerebral palsy is a non-progressive neurological disorder caused by early brain injury, resulting in unilateral motor impairment, muscle weakness, and balance dysfunction. The cross-education effect refers to the transfer of strength and motor improvements from a trained limb to the contralateral untrained limb, primarily mediated by central neural mechanisms.
A total of forty children diagnosed with HCP will be recruited from outpatient pediatric clinics affiliated with the Faculty of Physical Therapy, Cairo University. Eligible participants will be randomly allocated into two equal groups.
The study group will receive a conventional pediatric physiotherapy program combined with a structured progressive plyometric training program applied exclusively to the less affected lower limb. The control group will receive only the conventional physiotherapy program, which includes stretching exercises, active and resistive range of motion exercises, balance training, and gait training.
The intervention will be carried out over a period of twelve weeks, with two sessions per week, each lasting approximately one hour. The plyometric training will be designed to progressively challenge neuromuscular performance through exercises involving the stretch-shortening cycle, while the conventional program will focus on functional motor rehabilitation.
Allocation will be performed using a computer-generated block randomization method, and concealment will be ensured using sealed opaque envelopes. The study will adhere to CONSORT guidelines for randomized controlled trials to ensure methodological rigor and transparency.
Outcome measures will be assessed at baseline and post-intervention using standardized and validated tools to evaluate changes in muscle strength, selective motor control, and balance. Data analysis will be performed to determine the effectiveness of the intervention.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mayada Ghalwash Abdelkarem
- Número de teléfono: 0201556950163
- Correo electrónico: mayada.khedr59@gmail.com
Ubicaciones de estudio
-
-
-
Cairo, Egipto
- Faculty of physical therapy cairo university
-
Contacto:
- Mayada Ghalwash Abdelkarem, BSc PT
- Número de teléfono: 0201556950163
- Correo electrónico: mayada.khedr59@gmail.com
-
Giza, Egipto
- Physical Therapy Cairo University
-
Contacto:
- Mayada Ghalwash Abd, BSc PT
- Número de teléfono: 201556950163
- Correo electrónico: mayada.khedr59@gmail.com
-
-
Giza Governorate
-
Giza, Giza Governorate, Egipto, 11562
- Cairo University
-
Contacto:
- Mayada Ghalwash Abdelkarem, BSc PT
- Número de teléfono: 201556950163
- Correo electrónico: mayada.khedr59@gmail.com
-
Contacto:
- Mayada Ghalwash Abdelkarem
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:Children eligible for participation in this study must meet all the following criteria:
- Diagnosed with HCP by a pediatric neurologist.
- Age range 6 and 10 years old.
- Their grade of spasticity level 1 or 1+ according to MAS.
- Their gross motor function level is I, II on GMFCS.
- Able to follow verbal instructions and cooperate during assessment and training.
Exclusion Criteria:Children will be excluded from this study if they have any of the following:
- Presence of corrective neurological/musculoskeletal surgery of the lower limb in the previous year or botulinum toxin injections of the lower limb within the previous 6 months.
- Presence of visual or auditory impairments that would affect balance performance.
- Uncontrolled epileptic seizures or recent medication changes
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 |
|---|---|
|
Comparador activo: Grupo de control
|
Stretching, strengthening, balance, and gait training program.
|
|
Experimental: Grupo de estudio
|
Stretching, strengthening, balance, and gait training program.
The plyometric training program will be applied to the less affected lower limb and is designed to enhance neuromuscular performance, explosive strength, proprioception, and motor coordination through rapid eccentric-concentric muscle actions. Each training session will begin with a 5-minute warm-up to prepare the child physically and psychologically for exercise. The main training phase will include progressive plyometric exercises targeting lower limb function. A 5-minute cool-down period will be performed at the end of each session to promote muscle relaxation and reduce fatigue |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lower Limb Muscle Strength
Periodo de tiempo: 12 weeks
|
Lower limb muscle strength will be assessed in the more affected limb using a hand-held dynamometer (HHD). Quadriceps and hamstring muscle groups will be tested. The "make test" will be used to measure maximal isometric muscle strength. Each child will be instructed to gradually generate maximal force over approximately 5 seconds while maintaining a fixed joint position to avoid compensatory movements. The dynamometer will be stabilized and resistance applied via an ankle cuff positioned above the malleoli. Each muscle group will be tested three times, with 30 seconds rest between trials. The average of the three maximal voluntary contractions will be recorded as the final value. Standardized positioning and verbal encouragement will be used to ensure maximal effort |
12 weeks
|
|
Selective Motor Control (SMC)
Periodo de tiempo: 12 weeks
|
Selective motor control of the lower limb will be assessed using the Selective Control Assessment of the Lower Extremity (SCALE), which is a simple clinical tool that can be completed in less than 15 minutes and does not require special equipment (Fowler et al., 2009). The SCALE will be used to evaluate selective voluntary motor control at five joints of the lower limb including the hip, knee, ankle, subtalar joint, and toes on both sides. For each joint, a representative movement that is independent of typical synergistic flexor or extensor patterns will be selected. Most assessments will be performed in sitting position, while hip movements will be assessed in side-lying position to allow optimal observation of movement control. These standardized positions also facilitate visual feedback and accommodate potential proprioceptive deficits. The examiner will demonstrate each movement before testing. Children will then be asked to perform the movement independently, and performance wil |
12 weeks
|
|
Balance
Periodo de tiempo: 12 weeks
|
Postural stability will be assessed using the Biodex Balance System (BBS), a computerized dynamic platform used to evaluate neuromuscular control and balance performance.
The system allows controlled platform movement in anterior-posterior and medial-lateral directions and provides stability indices including the Overall Stability Index (OSI), Anteroposterior Stability Index (APSI), and Mediolateral Stability Index (MLSI), which reflect postural control abilities Prior to testing, each child will undergo a familiarization session to ensure understanding of the procedure and reduce anxiety.
During assessment, the child will stand barefoot on the platform in a two-leg stance with arms at the sides.
Safety handrails will be adjusted according to height, but children will be instructed not to hold them during testing.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Ejercicio pliométrico
Otros números de identificación del estudio
- P.T.REC/012/006103
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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. .