Cerebral PalsyNCT07921069
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
A study testing Sensory Integration Therapy and Conventional Physical Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to compare Sensory Integration Therapy (SIT) with Conventional Physical Therapy (CPT) for improving gross motor function in children aged 4-10 years with mixed cerebral palsy. This randomized controlled trial plans to include 50 participants divided into two groups. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sensory Integration Therapy and Conventional Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Oct 2026to Apr 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with mixed cerebral palsy.
- Medically stable children who are able to participate in the intervention sessions.
- Parent or legal guardian willing to provide written informed consent.
Who cannot join
- Children with severe cognitive or visual impairments.
- Children with uncontrolled seizures.
- Children with orthopedic deformities requiring surgery.
- Children who have received botulinum toxin injections within the previous six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Akhbar kare center Peshawar
Peshawar, Kpk, 25000
091-5822509
About this study
Official title: Sensory Integration Therapy Compared With Conventional Physical Therapy for Gross Motor Function in Children With Mixed Cerebral Palsy: A Randomized Controlled Trial
The study aims to compare Sensory Integration Therapy (SIT) with Conventional Physical Therapy (CPT) for improving gross motor function in children aged 4-10 years with mixed cerebral palsy. This randomized controlled trial plans to include 50 participants divided into two groups. Group A will receive Sensory Integration Therapy, while Group B will receive Conventional Physical Therapy over a 12-week intervention period. Outcomes will be assessed using the Gross Motor Function Measure (GMFM-88), Short Sensory Profile (SSP), and Parent-Reported Functional Independence \& Daily Activity Performance (PR-FADAP). Data will be analyzed using SPSS version 26, with statistical significance set at p < 0.05. The study is expected to determine which intervention is more effective in improving gross motor function and sensory processing in children with mixed cerebral palsy.
Read the detailed description
This randomized controlled trial aims to determine the effectiveness of Sensory Integration Therapy (SIT) compared with Conventional Physical Therapy (CPT) in improving gross motor function in children aged 4-10 years with mixed cerebral palsy. A total of 50 participants will be randomly allocated to two groups and receive their respective interventions for 12 weeks. Outcomes will be assessed using the Gross Motor Function Measure (GMFM-88), Short Sensory Profile (SSP), and PR-FADAP questionnaire. Data will be analyzed using SPSS version 26 to compare changes between the two groups.
- Conditions
- Cerebral Palsy
- Being tested
- Sensory Integration Therapy, Conventional Physical Therapy
- Keywords
- Sensory Integration Therapy, Conventional Physical Therapy, Mixed Cerebral Palsy, Gross Motor Function, Gross Motor Function Measure (GMFM-88), Short Sensory Profile (SSP), Pediatric Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration TherapyBehavioural
A 12-week sensory-motor intervention involving vestibular, tactile, and proprioceptive stimulation, balance and coordination activities, visual-motor tasks, graded multisensory challenges, and functional activities. The protocol specifies sessions of 60 minutes, with frequency progressing from 3 to 5 sessions per week.
Conventional Physical TherapyBehavioural
A 12-week conventional physical therapy program involving stretching, range-of-motion exercises, muscle strengthening, postural alignment, balance training, gait training, transitional movements, stair climbing, endurance activities, and functional task practice. The protocol specifies sessions of 60 minutes, with frequency progressing from 3 to 5 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Integration Therapy (SIT) | Experimental | Participants will receive Sensory Integration Therapy for 12 weeks, involving graded vestibular, tactile, and proprioceptive stimulation, balance and coordination activities, visual-motor tasks, multisensory play, and functional activities to improve gross motor function and sensory processing. Receives: Behavioral: Sensory Integration Therapy |
| Conventional Physical Therapy | Active comparator | Participants will receive conventional physical therapy for 12 weeks, including stretching, range-of-motion exercises, muscle strengthening, postural control, static and dynamic balance training, gait training, transitional movements, stair climbing, and functional task practice to improve gross motor function. Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure-88 (GMFM-88) Score
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized tool for evaluating motor function in children with cerebral palsy. Changes in scores will be compared between the Sensory Integration Therapy group and the Conventional Physical Therapy group.
Measured: Baseline and immediately after the 12-week intervention.
Secondary outcomes (2)
Change in Short Sensory Profile (SSP) Score
Sensory processing behaviors will be assessed using the Short Sensory Profile (SSP). Changes in scores from baseline to post-intervention will be compared between the two treatment groups.
Measured: Baseline and immediately after the 12-week intervention.
Change in Functional Independence and Daily Activity Performance
Functional independence and daily activity performance will be assessed using the Parent-Reported Functional Independence \& Daily Activity Performance (PR-FADAP) questionnaire, as specified in the study protocol. Changes in scores will be compared between the two treatment groups.
Measured: Baseline and immediately after the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start21 Oct 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwest General Hospital and Research centre
- Responsible party
- Sponsor
- Investigators
- Zobia Naeem, MS', Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921069
- Sponsor's protocol ID
- Laiba Awan
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
PubMed 16108461Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.
PubMed 16467053Khandaker G, Muhit M, Karim T, Smithers-Sheedy H, Novak I, Jones C, Badawi N. Epidemiology of cerebral palsy in Bangladesh: a population-based surveillance study. Dev Med Child Neurol. 2019 May;61(5):601-609. doi: 10.1111/dmcn.14013. Epub 2018 Nov 5.
PubMed 30394528Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Integration Therapy Compared With Conventional Physical Therapy for Gross Motor Function in Children With Mixed Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921069
- Acronym / sponsor ID
- Laiba Awan
- Conditions
- Cerebral Palsy
- Keywords
- Sensory Integration Therapy, Conventional Physical Therapy, Mixed Cerebral Palsy, Gross Motor Function, Gross Motor Function Measure (GMFM-88), Short Sensory Profile (SSP), Pediatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- Northwest General Hospital and Research centre
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Nov 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 study aims to compare Sensory Integration Therapy (SIT) with Conventional Physical Therapy (CPT) for improving gross motor function in children aged 4-10 years with mixed cerebral palsy. This randomized controlled trial plans to include 50 participants divided into two groups. Group A will receive Sensory Integration Therapy, while Group B will receive Conventional Physical Therapy over a 12-week intervention period. Outcomes will be assessed using the Gross Motor Function Measure (GMFM-88), Short Sensory Profile (SSP), and Parent-Reported Functional Independence \& Daily Activity Performance (PR-FADAP). Data will be analyzed using SPSS version 26, with statistical significance set at p < 0.05. The study is expected to determine which intervention is more effective in improving gross motor function and sensory processing in children with mixed cerebral palsy.
Detailed description
This randomized controlled trial aims to determine the effectiveness of Sensory Integration Therapy (SIT) compared with Conventional Physical Therapy (CPT) in improving gross motor function in children aged 4-10 years with mixed cerebral palsy. A total of 50 participants will be randomly allocated to two groups and receive their respective interventions for 12 weeks. Outcomes will be assessed using the Gross Motor Function Measure (GMFM-88), Short Sensory Profile (SSP), and PR-FADAP questionnaire. Data will be analyzed using SPSS version 26 to compare changes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Integration Therapy (SIT) | Experimental | Behavioral: Sensory Integration TherapyParticipants will receive Sensory Integration Therapy for 12 weeks, involving graded vestibular, tactile, and proprioceptive stimulation, balance and coordination activities, visual-motor tasks, multisensory play, and functional activities to improve gross motor function and sensory processing. |
| Conventional Physical Therapy | Active comparator | Behavioral: Conventional Physical TherapyParticipants will receive conventional physical therapy for 12 weeks, including stretching, range-of-motion exercises, muscle strengthening, postural control, static and dynamic balance training, gait training, transitional movements, stair climbing, and functional task practice to improve gross motor function. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with mixed cerebral palsy.
- Medically stable children who are able to participate in the intervention sessions.
- Parent or legal guardian willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Children with severe cognitive or visual impairments.
- Children with uncontrolled seizures.
- Children with orthopedic deformities requiring surgery.
- Children who have received botulinum toxin injections within the previous six months.
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 TherapyA 12-week sensory-motor intervention involving vestibular, tactile, and proprioceptive stimulation, balance and coordination activities, visual-motor tasks, graded multisensory challenges, and functional activities. The protocol specifies sessions of 60 minutes, with frequency progressing from 3 to 5 sessions per week. | Behavioural | Sensory Integration Therapy (SIT) |
| Conventional Physical TherapyA 12-week conventional physical therapy program involving stretching, range-of-motion exercises, muscle strengthening, postural alignment, balance training, gait training, transitional movements, stair climbing, endurance activities, and functional task practice. The protocol specifies sessions of 60 minutes, with frequency progressing from 3 to 5 sessions per week. | Behavioural | Conventional Physical Therapy |
Primary outcome
Change in Gross Motor Function Measure-88 (GMFM-88) Score
Time frame: Baseline and immediately after the 12-week intervention.
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized tool for evaluating motor function in children with cerebral palsy. Changes in scores will be compared between the Sensory Integration Therapy group and the Conventional Physical Therapy group.
2 secondary outcomes
Change in Short Sensory Profile (SSP) Score
Time frame: Baseline and immediately after the 12-week intervention.
Change in Functional Independence and Daily Activity Performance
Time frame: Baseline and immediately after the 12-week intervention.
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 6 Nov 2026.
- Background: PubMed 16108461Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Background: PubMed 16467053Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.
- Background: PubMed 30394528Khandaker G, Muhit M, Karim T, Smithers-Sheedy H, Novak I, Jones C, Badawi N. Epidemiology of cerebral palsy in Bangladesh: a population-based surveillance study. Dev Med Child Neurol. 2019 May;61(5):601-609. doi: 10.1111/dmcn.14013. Epub 2018 Nov 5.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- 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.
Zobia Naeem, MS' principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Therapy and Conventional Physical Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Salim Khan Dr. Salim Khan, MS (091-5822509, salim.khan@akbarkare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Function Measure-88 (GMFM-88) Score (time frame: Baseline and immediately after the 12-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921069, which also lists 4 linked publications.
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 6 Nov 2026.