Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For CP

Официальное название

Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For Upper Limb Functions In Children With Hemiplegic Cerebral Palsy

Обзор

Cerebral palsy is a neurological condition affecting movement and posture, caused by non-progressive brain disruptions occurring during fetal development. Constraint-induced movement therapy (CIMT) significantly improves arm and hand function in children with hemiparetic cerebral palsy by using intensive therapy sessions and restricting the unaffected limb to develop new motor skills. Bimanual therapy involves using both hands repeatedly to perform functional tasks, rather than relying on just one hand. Tele-rehabilitation (TR) is an affordable method of providing remote rehabilitation services through telecommunication technologies like smartphones and media applications. The aim of the study is to compare the effectiveness of CIMT and bimanual therapy delivered via tele-rehabilitation for improving upper limb function in children with cerebral palsy. This randomized clinical trial will be conducted at Mubarik Medical Complex, Sargodha, Pakistan, with a sample size of 65. Participants will be randomly allocated into two groups using an online randomization tool, Group A will receive constraint-induced movement therapy (CIMT) intervention for 60 minutes, and Group B will receive bimanual therapy intervention for 60 minutes. Each participant will undergo treatment for three days a week on alternate days for eight weeks. Spasticity will be assessed by using the Modified Ashworth Scale. The Quality of Upper Extremity Skills Test (QUEST) will evaluate dissociated movement, grasp, protective extension, and weight bearing, while the Tele-Rehabilitation Satisfaction Survey (TeSS) is designed to evaluate the experiences and satisfaction levels of patients or caregivers who have participated in tele-rehabilitation programs. Measurements will be taken at baseline, 4th week, 8th week, and at 12th week after discontinuation of treatment. The data will be entered and assessed using SPSS 26. For between-group analysis of parametric data, the independent t-test will be used, while non-parametric data will be analyzed using the Mann-Whitney test. Within-group comparisons will be conducted using repeated measures ANOVA for parametric data and Friedman ANOVA for non-parametric data.

Вмешательства

• Другое Constraint-induced movement therapy
  During the first routine checkup, therapists will educate caregivers on how to perform the exercises and activities at home. Caregivers will place the childrens less-affected hands in slings and guide them through exercises designed to engage their weaker, paretic hands. The sling will be fastened around the childrens trunks, with the end securely closed.After the initial session, the intervention will be provided by the caregiver at home, with progress monitored by the therapist through Zoom me
• Другое Hand Arm Bimanual Intensive Training -HABIT
  For the Bimanual Intensive Training group, a strategy similar to HABIT will be used. At the first routine checkup, therapists will educate caregivers on the exercises, which will then be conducted at home. Caregivers will guide children through specially designed bimanual activities without slings, focusing on tasks like reaching, grasping, manipulation, releasing, and bearing weight on the upper limb. Progress will be monitored remotely through Zoom or WhatsApp video calls.Exercises will includ

Первичные конечные точки

• Quality Of Upper Extremity Skills Test (QUEST) [Срок оценки: 8 weeks]
• Telehealth Satisfaction Scale [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Age 6-12 years.
• Children with hemiplegic cerebral palsy with mild to moderate hand involvement.
• Ability to extend wrist \>20° and fingers at the metacarpophalangeal joints

\>10° from full flexion

• Demonstrated ability to follow instructions during screening and complete the testing.
• Spasticity does not exceed a score of 1 or 1+ on the Modified Ashworth Scale

Критерии исключения

• Health problems unassociated with CP.
• Visual problems interfering with treatment.
• Active or unstable seizures.
• Orthopedic surgery on the more affected hand within the last year.

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Gorter JW, Rosenbaum PL, Hanna SE, Palisano RJ, Bartlett DJ, Russell DJ, Walter SD, Raina P, Galuppi BE, Wood E. Limb distribution, motor impairment, and functional classification of cerebral palsy. Dev Med Child Neurol. 2004 Jul;46(7):461-7. doi: 10.1017/s0012162204000763. PMID 15230459

Идентификаторы

NCT: NCT06658275 · REC/RCR&AHS/24/0234

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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