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Not yet recruiting NCT07733570

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

No phase Interventional Spastic Hemiplegic Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sensory Integration Therapy, Conventional Physical Therapy.
Who it may be relevant to
Registry conditions: Spastic Hemiplegic Cerebral Palsy. Basic parameters: 5 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 .

Detailed description

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.

Interventions

  • Other 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.
  • Other 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

Primary outcome measures

  • Edinburgh visual gait score [Time frame: 8 week]
Secondary outcome measures (2)
  • Gross Motor Function Measure -88(GMFM-88) [Time frame: 8 week]
  • Pediatric Balance Scale (PBS) [Time frame: 8 week]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗