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

NCT07733570 | Not Yet Recruiting

• 1 other identifier: Riphah/RCRAHS-ISB/REC/02575
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Spastic Hemiplegic Cerebral Palsy

Keywords

Spastic hemiplegic CP; Gait Symmetry; Functional Mobility; Balance; Conventional Physical Therapy; Edinburg Visual Gait Score; Gross Motor Function Measure; Neurodevelopmental Rehabilitation.

Outcome Measures

Primary Outcomes (1)

• Edinburgh visual gait score

  EVGS developed by Read and colleagues ,is an observational tool that evaluate gait quality in children with CP across 17 parameters and 6 body segment with score from 0-34 per limb ,where lower scores indicate near normal gait and higher score reflect greater abnormality.. It show Excellent reliability ICC of 0.947(95%) with a Cronbach's alpha value of 0.936,with minimal detectable change of 4.78 to 6.0 points.The EVGS showed good construct validity with a negative correlation with the GMFM-66 (r = -0.50 to -0.70), it also show moderate agreement 52% to 73%, with 3D gait analysis ,supporting criterion validity. In hemiplegic CP, useful for assessing gait symmetry between limbs.The maximum total Score per extermity is 34, the lower then maximum indicate less gait deviation.

  8 week

Secondary Outcomes (2)

• Gross Motor Function Measure -88(GMFM-88)

  8 week

• Pediatric Balance Scale (PBS)

  8 week

Study Arms (2)

Experimental Group : SIT Plus Conventional

EXPERIMENTAL

Participants in this arm will receive Sensory Integration Therapy (SIT) for 25 minutes, followed by conventional physiotherapy for 20 minutes, per session. Sessions will be conducted 3 times per week for 8 weeks. SIT activities will include vestibular stimulation , proprioceptive input and tactile stimulation using varied textures, progressing over the 8 weeks to advanced sensory integration tasks, obstacle navigation, and dual-task training. Conventional physiotherapy will include stretching, range of motion exercises, sitting and standing balance training, sit-to-stand practice, and gait training, progressing to independent walking, task-oriented activities, and community mobility practice.

Other: Sensory Integration Therapy; Other: Conventional Physical Therapy

Control Group: Conventional Physical Therapy

ACTIVE COMPARATOR

Participants in this arm will receive conventional physiotherapy only, for 45 minutes per session, 3 times per week for 8 weeks. Treatment will include stretching exercises, range of motion (ROM) exercises, sitting and standing balance training, weight shifting, and reaching activities in the early weeks, progressing to gait training, postural correction exercises, independent standing and walking practice, and functional mobility tasks. By the final weeks, sessions will include advanced gait and balance training, increased endurance activities, and community-level walking practice.

Other: Conventional Physical Therapy

Interventions

Sensory Integration Therapy OTHER

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.

Also known as: Conventional physical therapy

Experimental Group : SIT Plus Conventional

Conventional Physical Therapy OTHER

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 post-intervention (Week 9) using EVGS, GMFM-88, and PBS.

Control Group: Conventional Physical Therapy; Experimental Group : SIT Plus Conventional

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Officials

• Arfa Murtaza, MS-PT*

  Riphah International University ,Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sidra Ghias Dr.Sidra Ghias, Phd*

CONTACT

03224356227; sidra.ghias@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 22, 2026
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share