Effects of Sensory Integration Therapy in Children With Spastic Hemiplegic Cerebral Palsy

Официальное название

Effects of Sensory Integration Therapy on Functional Mobility ,Balance and Gait Symmetry in Children With Spastic Hemiplegic CP :A Randomized Trial

Обзор

The Goal of this Clinical Trial is to learn if a treatmnet called Sensory Integration Therapy (SIT) can Improve walking,Balance and movemnet in children with a type of cerebral palsy called spastic hemiplegic Cerebral Palsy .This Condition affects one side of body and make walking uneven.The study will include children between 5-12 year old . The main Question this study aims to answer are : Does adding SIT to regular physical therapy improve How symmetrically children walk? Does adding SIT to regular physical therapy improve balance and daily movements skills,compared with regular/conventional Physical Therapy Alone. Researches will compare two group of children to see if SIT + Conventional Physical Therapy work better then Convential Physical therapy alone . Participant will be palaced into one of two groups by chance one group will recieive SIT alone with COnventional PT,the other group will recieve Conventional Therapy Alone only. Attend Therapy session 3 time a week for 8 week Be tested before and after the 8 week using simple movement and balence tests,including a walking assessment done By video .

Подробное описание

This study is a randomized controlled trial evaluating whether Sensory Integration Therapy (SIT), when combined with conventional physiotherapy, produces greater improvements in gait symmetry, functional mobility, and balance than conventional physiotherapy alone in children aged 5-12 years with spastic hemiplegic cerebral palsy (CP).

Thirty-two participants will be recruited using non-probability consecutive sampling and then randomly allocated into two equal groups. Group A (experimental) will receive SIT (25 minutes) followed by conventional physiotherapy (20 minutes) per session. Group B (control) will receive conventional physiotherapy alone (45 minutes) per session. Both groups will attend 3 sessions per week for 8 weeks. Treatment content will progress in complexity over four two-week blocks, moving from foundational sensory and mobility activities to advanced, community-level functional tasks.

Outcomes will be assessed using three standardized tools: the Gross Motor Function Measure (GMFM-88), the Pediatric Balance Scale (PBS), and the Edinburgh Visual Gait Score (EVGS), a video-based observational gait analysis tool particularly suited to detecting asymmetry between the affected and unaffected limbs in hemiplegic CP. Assessments will be conducted at baseline and following the intervention period.

This study addresses a gap in the literature, as most prior research on SIT in CP has focused on spastic diplegic subtypes, with comparatively little evidence specific to spastic hemiplegic CP or to gait symmetry as a primary outcome. Data will be analyzed using SPSS, with a mixed-design repeated-measures ANOVA used to evaluate the effects of time, group, and the group-by-time interaction, followed by post hoc analysis where indicated.

Вмешательства

• Другое Sensory Integration Therapy
  Sensory Integration Therapy (SIT) involved play-based sensory-motor activities targeting tactile, proprioceptive, and vestibular systems, including swinging, weight bearing, and tactile stimulation, progressing to advanced sensory tasks and dual-task training. Provided for 25 minutes per session, followed by 20 minutes of conventional physiotherapy, 3 times per week for 8 weeks.
• Другое Conventional Physical Therapy
  Participants in the control group will receive conventional physiotherapy alone, for 45 minutes per session, 3 times per week, over 8 weeks. Treatment will progress from basic stretching, range of motion exercises, and sitting/standing balance training in the early weeks, to gait training and postural correction by the middle weeks, and finally to advanced balance, endurance, and independent community-level walking practice by the final weeks. Outcomes will be assessed at baseline (Week 0) and p

Первичные конечные точки

• Edinburgh visual gait score [Срок оценки: 8 week]

Вторичные конечные точки (2)

• Gross Motor Function Measure -88(GMFM-88) [Срок оценки: 8 week]
• Pediatric Balance Scale (PBS) [Срок оценки: 8 week]

Критерии участия

Критерии включения

• Children aged 5-12 years diagnosed with spastic hemiplegic CP
• GMFCS level I-III
• able to follow simple commands

Критерии исключения

• Severe cognitive impairment
• recent orthopedic surgery
• uncontrolled seizures.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07733570 · Riphah/RCRAHS-ISB/REC/02575

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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