Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis

Обзор

To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on: 1. Strength of ankle muscles in children with hemiparesis. 2. Balance in children with hemiparesis.

Подробное описание

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.

Вмешательства

• Другое Selected therapeutic program
  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.
• Другое Selected Task oriented training program
  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. Walk
• Устройство Selected Functional electrical stimulation
  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.

Первичные конечные точки

• Assessment of balance [Срок оценки: at baseline and after 8 weeks]

Вторичные конечные точки (1)

• Assessment of muscle strength [Срок оценки: at baseline and after 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Damietta general hospital. — Damietta

Идентификаторы

NCT: NCT07648511 · Nourhan_Msc

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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