Spastic Hemiplegic Cerebral PalsyNCT07733570
Effects of Sensory Integration Therapy in Children With Spastic Hemiplegic Cerebral Palsy
A study testing Sensory Integration Therapy and Conventional Physical Therapy in people with Spastic Hemiplegic Cerebral Palsy, run by Riphah International University.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Sensory Integration Therapy and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2026to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-12 years diagnosed with spastic hemiplegic CP
- GMFCS level I-III
- able to follow simple commands
Who cannot join
- Severe cognitive impairment
- recent orthopedic surgery
- uncontrolled seizures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Sensory Integration Therapy on Functional Mobility ,Balance and Gait Symmetry in Children With Spastic Hemiplegic CP :A Randomized Trial
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 :
Read more
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 .
Read the 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.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Sensory Integration Therapy, Conventional Physical Therapy
- Keywords
- Spastic hemiplegic CP, Gait Symmetry, Functional Mobility, Balance, Conventional Physical Therapy, Edinburg Visual Gait Score, Gross Motor Function Measure, Neurodevelopmental Rehabilitation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration TherapyOther
Also called Conventional physical 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.
Conventional Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
Secondary outcomes (2)
Gross Motor Function Measure -88(GMFM-88)
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
Measured: 8 week
Pediatric Balance Scale (PBS)
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start22 Aug 2026 (estimated)
- Primary completion22 Mar 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arfa Murtaza, MS-PT*, Principal investigator, Riphah International University ,Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733570
- Sponsor's protocol ID
- Riphah/RCRAHS-ISB/REC/02575
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensory Integration Therapy on Functional Mobility ,Balance and Gait Symmetry in Children With Spastic Hemiplegic CP :A Randomized Trial
- ClinicalTrials.gov ID
- NCT07733570
- Acronym / sponsor ID
- Riphah/RCRAHS-ISB/REC/02575
- 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.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Aug 2026 (estimated)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group : SIT Plus Conventional | Experimental | Other: Sensory Integration Therapy, Other: Conventional Physical TherapyParticipants 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. |
| Control Group: Conventional Physical Therapy | Active comparator | Other: Conventional Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-12 years diagnosed with spastic hemiplegic CP
- GMFCS level I-III
- able to follow simple commands
Key exclusion criteria (3 listed)
- Severe cognitive impairment
- recent orthopedic surgery
- uncontrolled seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Integration TherapyAlso: Conventional physical therapySensory 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 | Experimental Group : SIT Plus Conventional |
| Conventional Physical TherapyParticipants 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. | Other | Control Group: Conventional Physical Therapy, Experimental Group : SIT Plus Conventional |
Primary outcome
Edinburgh visual gait score
Time frame: 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.
2 secondary outcomes
Gross Motor Function Measure -88(GMFM-88)
Time frame: 8 week
Pediatric Balance Scale (PBS)
Time frame: 8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arfa Murtaza, MS-PT* principal investigator
Riphah International University ,Islamabad
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Therapy and Conventional Physical Therapy in people with Spastic Hemiplegic Cerebral Palsy, run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sidra Ghias Dr.Sidra Ghias, Phd* (03224356227, sidra.ghias@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh visual gait score (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.