Cerebral PalsyNCT07836517
Sensory-Motor Integration Versus Virtual Reality-Based Exercise in Children With Cerebral Palsy
A study testing Sensory-Motor Integration-Based Exercise Program and Virtual Reality-Based Exercise Program in people with Cerebral Palsy, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sensory-Motor Integration-Based Exercise Program and Virtual Reality-Based Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Dec 2026
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with cerebral palsy, including diplegic, hemiplegic, or dyskinetic types
- Gross Motor Function Classification System level I, II, or III
- Aged between 6 and 12 years
- Having sufficient cognitive ability to understand and follow simple verbal instructions
- Voluntary participation in the study with legal guardian consent
Who cannot join
- Gross Motor Function Classification System level IV or V
- Spasticity level of 2 or higher in target muscle groups according to the Modified Ashworth Scale
- Botulinum toxin injection within the last 6 months
- Orthopedic or neurological surgery affecting motor function within the last 6 months
- History of uncontrolled epilepsy or neurological conditions contraindicating virtual reality applications
- Severe visual or hearing impairment that may prevent participation in the study
- Concurrent participation in another rehabilitation program during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Clinical Effectiveness of Sensory-Motor Integration and Virtual Reality-Based Exercise Programs for Enhancing Functional Mobility in Children With Cerebral Palsy: Strengthening Steps Through Play and Technology
This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.
Read the detailed description
Cerebral palsy is a non-progressive neurodevelopmental condition characterized by permanent impairments in movement, posture, and motor function. Children with cerebral palsy may experience limitations in postural control, balance, motor planning, sensory processing, functional mobility, and participation in physical activity. Conventional physiotherapy is widely used in the rehabilitation of children with cerebral palsy and commonly includes tone regulation, stretching, strengthening, balance training, aerobic exercises, and functional activity training. However, additional rehabilitation approaches may be needed to support multidimensional motor and functional outcomes.
This study is designed as a two-arm, randomized controlled, parallel-group, prospective clinical intervention study. The aim is to compare the effects of two adjunctive rehabilitation approaches added to standard conventional physiotherapy: a Sensory-Motor Integration-Based Exercise Program and a Virtual Reality-Based Exercise Program using Nintendo Wii Sports.
Eligible children with cerebral palsy will be enrolled after obtaining informed consent from their legal guardians. Participants will be randomly assigned to one of two groups using a computer-based simple randomization method.
Participants in the first group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. This program is designed to target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs.
Participants in the second group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. This program will provide visual and auditory feedback in a game-based environment and will aim to increase motivation, task-oriented movement repetition, balance, and functional motor performance.
The intervention period will last 16 weeks, with two sessions per week for both groups. All participants will be evaluated at baseline before the intervention and after completion of the 16-week intervention period. The primary outcome measures will include the Gross Motor Function Measure dimensions D and E, the Pediatric Balance Scale, and the Timed Up and Go Test. Secondary outcome measures will include ABILHAND-Kids, hand grip strength measured with a dynamometer, and the Physical Activity Self-Efficacy Scale for Children.
The study is expected to provide clinical evidence regarding the comparative effectiveness of sensory-motor integration-based exercises and virtual reality-based exercises as adjunctive interventions to conventional physiotherapy in children with cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Sensory-Motor Integration-Based Exercise Program, Virtual Reality-Based Exercise Program
- Keywords
- Cerebral Palsy, Sensory-Motor Integration, Virtual Reality, Gross Motor Function, Functional Mobility, 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-Motor Integration-Based Exercise ProgramBehavioural
Also called SMIBEP
A structured sensory-motor integration-based exercise program targeting postural control, balance, motor planning, sensory processing, body awareness, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The program will be administered in addition to standard conventional physiotherapy.
Virtual Reality-Based Exercise ProgramBehavioural
Also called VRBEP
A Nintendo Wii Sports-based virtual reality exercise program using visual and auditory feedback in a game-based environment to support motivation, task-oriented movement repetition, balance, and functional motor performance. The program will be administered in addition to standard conventional physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Sensory-Motor Integration-Based Exercise Program | Experimental | Participants in this group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. The program will target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The intervention will be delivered for 16 weeks, two sessions per week. Receives: Behavioral: Sensory-Motor Integration-Based Exercise Program |
| Virtual Reality-Based Exercise Program | Active comparator | Participants in this group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. The program will provide visual and auditory feedback in a game-based environment and will aim to improve motivation, task-oriented movement repetition, balance, and functional motor performance. The intervention will be delivered for 16 weeks, two sessions per week. Receives: Behavioral: Virtual Reality-Based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure Dimensions D and E Score
Gross motor function will be assessed using the Gross Motor Function Measure, dimensions D and E. The assessment will evaluate standing, walking, running, and jumping-related gross motor abilities in children with cerebral palsy.
Measured: Baseline and week 17
Change in Pediatric Balance Scale Score
Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance.
Measured: Baseline and week 17
Change in Timed Up and Go Test Performance
Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Shorter completion time indicates better functional mobility.
Measured: Baseline and week 17
Secondary outcomes (3)
Change in ABILHAND-Kids Score
Upper extremity and hand function in daily activities will be assessed using the ABILHAND-Kids questionnaire completed with parent or caregiver report.
Measured: Baseline and week 17
Change in Hand Grip Strength
Hand grip strength will be measured using a calibrated hand dynamometer according to a standardized testing position. Measurements will be performed for each hand, and the highest value will be used for analysis.
Measured: Baseline and week 17
Change in Physical Activity Self-Efficacy Scale for Children Score
Physical activity self-efficacy will be assessed using the Physical Activity Self-Efficacy Scale for Children to evaluate children's perceived confidence and ability to participate in physical activity.
Measured: Baseline and week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Participants will be randomly assigned to one of two parallel groups. Both groups will receive standard conventional physiotherapy. One group will additionally receive a Sensory-Motor Integration-Based Exercise Program, while the other group will additionally receive a Nintendo Wii Sports-based Virtual Reality Exercise Program. Both interventions will be delivered for 16 weeks, two sessions per week.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836517
- Sponsor's protocol ID
- YEDU-FTR-CP-SMI-VR-2026-001
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size, pediatric population, and privacy considerations. De-identified aggregate results may be reported in scientific publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Effectiveness of Sensory-Motor Integration and Virtual Reality-Based Exercise Programs for Enhancing Functional Mobility in Children With Cerebral Palsy: Strengthening Steps Through Play and Technology
- ClinicalTrials.gov ID
- NCT07836517
- Acronym / sponsor ID
- YEDU-FTR-CP-SMI-VR-2026-001
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Sensory-Motor Integration, Virtual Reality, Gross Motor Function, Functional Mobility, Pediatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 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.
This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.
Detailed description
Cerebral palsy is a non-progressive neurodevelopmental condition characterized by permanent impairments in movement, posture, and motor function. Children with cerebral palsy may experience limitations in postural control, balance, motor planning, sensory processing, functional mobility, and participation in physical activity. Conventional physiotherapy is widely used in the rehabilitation of children with cerebral palsy and commonly includes tone regulation, stretching, strengthening, balance training, aerobic exercises, and functional activity training. However, additional rehabilitation approaches may be needed to support multidimensional motor and functional outcomes.
This study is designed as a two-arm, randomized controlled, parallel-group, prospective clinical intervention study. The aim is to compare the effects of two adjunctive rehabilitation approaches added to standard conventional physiotherapy: a Sensory-Motor Integration-Based Exercise Program and a Virtual Reality-Based Exercise Program using Nintendo Wii Sports.
Eligible children with cerebral palsy will be enrolled after obtaining informed consent from their legal guardians. Participants will be randomly assigned to one of two groups using a computer-based simple randomization method.
Participants in the first group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. This program is designed to target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs.
Participants in the second group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. This program will provide visual and auditory feedback in a game-based environment and will aim to increase motivation, task-oriented movement repetition, balance, and functional motor performance.
The intervention period will last 16 weeks, with two sessions per week for both groups. All participants will be evaluated at baseline before the intervention and after completion of the 16-week intervention period. The primary outcome measures will include the Gross Motor Function Measure dimensions D and E, the Pediatric Balance Scale, and the Timed Up and Go Test. Secondary outcome measures will include ABILHAND-Kids, hand grip strength measured with a dynamometer, and the Physical Activity Self-Efficacy Scale for Children.
The study is expected to provide clinical evidence regarding the comparative effectiveness of sensory-motor integration-based exercises and virtual reality-based exercises as adjunctive interventions to conventional physiotherapy in children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. Both groups will receive standard conventional physiotherapy. One group will additionally receive a Sensory-Motor Integration-Based Exercise Program, while the other group will additionally receive a Nintendo Wii Sports-based Virtual Reality Exercise Program. Both interventions will be delivered for 16 weeks, two sessions per week.
| Arm | Type | Receives |
|---|---|---|
| Sensory-Motor Integration-Based Exercise Program | Experimental | Behavioral: Sensory-Motor Integration-Based Exercise ProgramParticipants in this group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. The program will target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The intervention will be delivered for 16 weeks, two sessions per week. |
| Virtual Reality-Based Exercise Program | Active comparator | Behavioral: Virtual Reality-Based Exercise ProgramParticipants in this group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. The program will provide visual and auditory feedback in a game-based environment and will aim to improve motivation, task-oriented movement repetition, balance, and functional motor performance. The intervention will be delivered for 16 weeks, two sessions per week. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with cerebral palsy, including diplegic, hemiplegic, or dyskinetic types
- Gross Motor Function Classification System level I, II, or III
- Aged between 6 and 12 years
- Having sufficient cognitive ability to understand and follow simple verbal instructions
- Voluntary participation in the study with legal guardian consent
Key exclusion criteria (7 listed)
- Gross Motor Function Classification System level IV or V
- Spasticity level of 2 or higher in target muscle groups according to the Modified Ashworth Scale
- Botulinum toxin injection within the last 6 months
- Orthopedic or neurological surgery affecting motor function within the last 6 months
- History of uncontrolled epilepsy or neurological conditions contraindicating virtual reality applications
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-Motor Integration-Based Exercise ProgramAlso: SMIBEPA structured sensory-motor integration-based exercise program targeting postural control, balance, motor planning, sensory processing, body awareness, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The program will be administered in addition to standard conventional physiotherapy. | Behavioural | Sensory-Motor Integration-Based Exercise Program |
| Virtual Reality-Based Exercise ProgramAlso: VRBEPA Nintendo Wii Sports-based virtual reality exercise program using visual and auditory feedback in a game-based environment to support motivation, task-oriented movement repetition, balance, and functional motor performance. The program will be administered in addition to standard conventional physiotherapy. | Behavioural | Virtual Reality-Based Exercise Program |
Primary outcome
Change in Gross Motor Function Measure Dimensions D and E Score
Time frame: Baseline and week 17
Gross motor function will be assessed using the Gross Motor Function Measure, dimensions D and E. The assessment will evaluate standing, walking, running, and jumping-related gross motor abilities in children with cerebral palsy.
Change in Pediatric Balance Scale Score
Time frame: Baseline and week 17
Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance.
Change in Timed Up and Go Test Performance
Time frame: Baseline and week 17
Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Shorter completion time indicates better functional mobility.
3 secondary outcomes
Change in ABILHAND-Kids Score
Time frame: Baseline and week 17
Change in Hand Grip Strength
Time frame: Baseline and week 17
Change in Physical Activity Self-Efficacy Scale for Children Score
Time frame: Baseline and week 17
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 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size, pediatric population, and privacy considerations. De-identified aggregate results may be reported in scientific publications or presentations.
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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.
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-Motor Integration-Based Exercise Program and Virtual Reality-Based Exercise Program in people with Cerebral Palsy, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 23 Sep 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 Turkey (Türkiye). 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 Elif Develi, PhD (+90 555 593 6293, elifstn@yahoo.com), 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 Dimensions D and E Score (time frame: Baseline and week 17). The study lists 3 primary outcomes in all. 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 23 Sep 2026.