Effects of Robotic Hand Therapy on Hand Function and Dexterity in Cerebral Palsy

Официальное название

Effects of Robotic Hand Therapy in Comparison to Conventional Therapy on Hand Function and Dexterity in Children With Hemiplegic Cerebral Palsy; a Randomized Controlled Trial

Обзор

This randomized controlled trial aims to evaluate the effects of robotic hand therapy using the Syrebo E12 soft-robotic glove compared with conventional physiotherapy on hand function and manual dexterity in children with hemiplegic cerebral palsy. Children aged 7-15 years, classified as GMFCS I-III and MACS I-III, will be recruited from multiple rehabilitation centers in Pakistan. Participants will be randomly allocated (1:1) to either robotic therapy or standard physiotherapy, receiving 45-minute sessions, three times per week for 8 weeks. The primary outcome is functional hand performance measured by the Jebsen-Taylor Hand Function Test (JTHFT). Secondary outcomes include ABILHAND-Kids, Box and Block Test, Nine-Hole Peg Test, grip strength, and qualitative feedback. Assessments will occur at baseline, week 4, week 8, and at a 6-month follow-up. A mixed-effects repeated-measures ANCOVA will be used for analysis following the intention-to-treat principle.

Вмешательства

• Устройство Robotic Hand Therapy
  Participants in this group will receive robotic hand therapy using a glove-based robotic rehabilitation device that provides passive, active-assisted, and resistive training to facilitate repetitive, task-specific hand movements. Each 45-minute session will be delivered three times per week for six weeks under therapist supervision, focusing on improving grasp-release patterns, finger mobility, and functional hand use. Therapy intensity will be progressively adjusted based on performance and tol
• Другое Conventional physical Therapy
  Participants in this group will receive conventional physical therapy based on neurodevelopmental and task-oriented principles, including stretching, strengthening, sensory re-education, and functional hand-use training. Sessions will last 45 minutes, three times per week for six weeks, delivered by a licensed physical therapist following a standardized treatment checklist. The program targets improvements in hand strength, dexterity, range of motion, and fine motor skills, with safety and treat

Первичные конечные точки

• Jebsen-Taylor Hand Function Test [Срок оценки: 8 Weeks]

Вторичные конечные точки (4)

• ABILHAND-Kids [Срок оценки: 8 Weeks]
• Box and Block Test [Срок оценки: 8 Weeks]
• Nine-Hole Peg Test (NHPT) [Срок оценки: 8 weeks]
• o'connor test [Срок оценки: 8 Weeks]

Критерии участия

Критерии включения

• Patients diagnosed with Hemiplegic type of Cerebral palsy
• Age 7 to 15 years
• Ability to understand and follow simple instructions
• Gross Motor Function Classification System (GMFCS) levels I-III (ambulatory)
• Manual Ability Classification system (MACS) I to III
• Stable medical condition (no major changes in medication or therapy in the past 3 months).

Критерии исключения

• Patients with severe cognitive dysfunction.
• Fixed contractures or deformities of the upper limb that would prevent safe use of the robotic device.
• Recent upper limb surgery, botulinum toxin injection, or casting within the past 6 months.
• Uncontrolled epilepsy or other unstable medical conditions.
• Visual or auditory impairments that would interfere with assessment or therapy.

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

Пакистан · 1 центр

• Riphah International University — Islamabad

Идентификаторы

NCT: NCT07571668 · RCRAHS-ISB/REC/PhD/011110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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