Effects of CIMT With and Without Robotic Gloves in Children With Hemiplegic CP

Официальное название

Effects of Constraint Induced Movement Therapy With and Without Robotic Glove on Dexterity and Hand Grip Strength in Children With Hemiplegic Cerebral Palsy

Обзор

This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

Подробное описание

Hemiplegic cerebral palsy (CP) often affects one side of the body, limiting functional abilities. Constraint-Induced Movement Therapy (CIMT) is a common intervention where the unaffected hand is restricted to encourage the use of the affected hand. Recently, the addition of robotic gloves has been proposed to improve outcomes, as they offer mechanical support and feedback to the affected hand. This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

Вмешательства

• Другое CIMT with robotic glove
  The Experimental group undergoes a comprehensive rehabilitation program, combining Constraint-Induced Movement Therapy (CIMT) with robotic glove therapy. The unaffected limb is restrained by the help of Slings, Simple glove, splint or plaster. Each session lasts 6 Hours, occurring 3-5 Days a weekly, over a period of 4-8 weeks. This intensive regimen aims to enhance hand function and mobility by constraining the unaffected hand while using the robotic glove to facilitate precise finger movements.
• Другое CIMT with standard rehabilitation
  Controlled group receives CIMT with baseline rehabilitation. Only receives CIMT without Robotic Gloves. Additional assessments may be conducted after 3 or 6 months to measure long-term effects.

Первичные конечные точки

• Grip Strength Test [Срок оценки: 4-8 weeks]
• Box and Block Test [Срок оценки: 4-8 weeks]

Критерии участия

Критерии включения

• Children aged 6-12 years with Hemiplegic CP.
• Both Genders will be included.
• Fulfilling the CIMT criteria i.e. Up to 20 Degree Wrist Extension, up to 10 Degree
• Thumb Abduction and Up to 10 Degree Finger Extension.
• GMFCS level of 1 and 2.
• MAC Grade 2 and 3.
• Ability to understand and follow simple instructions.

Критерии исключения

• Severe cognitive impairment or intellectual disability.
• Presence of other neurological disorders such as epilepsy.
• Children currently participating in other intensive physical therapy programs.

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

Другое

Центры проведения

Пакистан · 1 центр

• Imran Amjad — Lahore

Публикации

• Osuagwu BAC, Timms S, Peachment R, Dowie S, Thrussell H, Cross S, Shirley R, Segura-Fragoso A, Taylor J. Home-based rehabilitation using a soft robotic hand glove device leads to improvement in hand function in people with chronic spinal cord injury:a pilot study. J Neuroeng Rehabil. 2020 Mar 5;17(1):40. doi: 10.1186/s12984-020-00660-y. PMID 32138780

Идентификаторы

NCT: NCT07248735 · REC/RCR&AHS/AFTAB ANSAR LODHI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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