Spastic Hemiplegic Cerebral Palsy
Conditions
Keywords
Spastic hemiplegic CP, Gait Symmetry, Functional Mobility, Balance, Conventional Physical Therapy, Edinburg Visual Gait Score, Gross Motor Function Measure, Neurodevelopmental Rehabilitation.
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 .
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
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.
OTHERConventional 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 post-intervention (Week 9) using EVGS, GMFM-88, and PBS.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh visual gait score | 8 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure -88(GMFM-88) | 8 week | The GMFM-88 is an observational gold standard assessment tool used to assess gross motor function in children with CP, It include 88 item/dimension that are divided into 5 areas. Each task is given a score on 4 point scale from 0 to 3,where 0 indicate the child inability to start the task at all and 3 mean the task is fully completed.GMFM-88 is a highly reliable tool with an overall ICC of 0.99 and Intra-rater reliability ranging from with ICC 0.96 and 0.99 across all five areas. Measurement Precision is supported by the SEM of 1.60 and the SRD of 3.14, reflecting stable and trustworthy results in a clinical setting. The tool showed a strong validity ,with high correlation (r = 0.82) with independent clinical judgment and good concurrent validity, with PEDI mobility domain 0.799 to 0.988 |
| Pediatric Balance Scale (PBS) | 8 week | The Pediatric Balance Scale (PBS),adapted from Berg Balance Scale is design to evaluate balance in school-age children with mild to moderate motor impairment. It consist of 14 functional tasks scored on 5 point scale (0 to 4), with maximum score of 56. A higher score means better balance. The Tool show excellent reliability with test -retest ICC = 0.998 and inter-rater reliability ICC = 0.997 in children age 5 to 15 years. Items Level agreement was also strong,( kappa = 0.87 to 1.0). In spastic CP ,the PBS showed high relative reliability with satisfactory absolute reliability based ( SEM and SRD) indicating consistent and reliable results across raters and time. PBS showed a strong concurrent validity with GMFM-88 ( r = 0.926) and with GMFM-66 (r = 0.902) at baseline ,0.89-0.92 at follow up . Additionally a strong and significant co-relation with the mobility section of the PEDI (r = 0.82, p \< 0.001)in spastic CP aged 4 to 10y. |
Contacts
CONTACTSidra Ghias Dr.Sidra Ghias, Phd*
PRINCIPAL_INVESTIGATORArfa Murtaza, MS-PT*
Riphah International University ,Islamabad
Outcome results
None listed