Cerebral PalsyNCT07685327
Comparing Mixed Reality and Physical Therapy to Improve Balance and Coordination in Adolescents With Spastic Diplegic Cerebral Palsy
A study testing Meta Quest Pro Mixed Reality System and Standard Physical Therapy in people with Cerebral Palsy and Spastic Diplegic Cerebral Palsy, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality (MR) combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegic Cerebral Palsy
- What is being tested?
- Meta Quest Pro Mixed Reality System and Standard Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jan 2026to 1 Aug 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female participants.
- Adolescents aged 10 to 19 years.
- Clinically diagnosed with spastic diplegic cerebral palsy.
- Gross Motor Function Classification System (GMFCS) Levels I, II, or III.
- Pediatric Balance Scale (PBS) score greater than 35.
- Willing to participate in the study and provide written informed consent/assent with parental or legal guardian consent where applicable.
Who cannot join
- Cognitive impairment (MMSE score <24).
- History of seizure disorders.
- Visual or hearing impairment that interferes with participation.
- Diagnosed psychological or psychiatric disorders.
- Any other medical condition that would prevent safe participation in the study.
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
Helping hand Comprehansive Physical Rehabilitation Center Mansehra
Mansehra, Kpk, 21300
Muhammad Yaseen Khattak, MS-PPT, 03440957080, yaseenkhattak391@gmail.com
About this study
Official title: Effect Of Fully Immersive Mixed Reality Versus Standard Physical Therapy For Improving Balance And Coordination In Adolescent With Spastic Diplegic Cerebral Palsy" A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality (MR) combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10 to 19 years will be randomly assigned to one of two treatment groups. The intervention will be provided three times per week for eight weeks. Balance and coordination will be assessed before treatment, at four weeks, and after completion of the intervention using validated clinical outcome measures. The findings of this study may help determine whether immersive Mixed Reality can enhance rehabilitation outcomes in adolescents with cerebral palsy.
Read the detailed description
erebral palsy (CP) is one of the most common neurological disorders affecting movement, balance, posture, and coordination in children and adolescents. Spastic diplegic cerebral palsy is characterized by increased muscle tone predominantly affecting the lower limbs, resulting in impaired balance, reduced coordination, and limitations in functional mobility. Conventional physical therapy is considered the standard rehabilitation approach; however, patient motivation and treatment adherence may limit its effectiveness.
Mixed Reality (MR) technology provides an immersive and interactive rehabilitation environment that combines virtual and real-world elements, enabling repetitive, task-oriented training with real-time feedback. Such interventions may enhance motor learning, neuroplasticity, patient engagement, and functional recovery. Despite promising evidence regarding immersive virtual reality interventions, limited randomized controlled trials have compared fully immersive Mixed Reality with conventional physical therapy in adolescents with spastic diplegic cerebral palsy.
This single-blinded randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10-19 years who meet the eligibility criteria will be recruited and randomly allocated into two equal groups. Group A will receive fully immersive Mixed Reality training using the Meta Quest Pro platform in combination with standardized physical therapy, while Group B will receive standardized physical therapy alone. Both groups will receive treatment three sessions per week for eight weeks.
Outcome assessments will be performed at baseline, after four weeks, and after completion of the eight-week intervention. Balance will be evaluated using the Pediatric Balance Scale (PBS), while coordination will be assessed using the Comprehensive Coordination Scale (CCS). The findings of this study will provide evidence regarding the effectiveness of fully immersive Mixed Reality as an adjunct to conventional physical therapy and may contribute to improving rehabilitation strategies for adolescents with spastic diplegic cerebral palsy.
- Conditions
- Cerebral Palsy, Spastic Diplegic Cerebral Palsy
- Being tested
- Meta Quest Pro Mixed Reality System, Standard Physical Therapy
- Keywords
- Cerebral Palsy, Mixed Reality, Fully Immersive Mixed Reality, 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.
Meta Quest Pro Mixed Reality SystemDevice
Participants will receive fully immersive Mixed Reality rehabilitation using the Meta Quest Pro headset in combination with standardized physical therapy. The intervention includes interactive applications such as Beat Saber, Ball Balance, Run and Cycling, Running Monkeys, and Back to Subway Surfer. Treatment will be provided three sessions per week for eight weeks to improve balance and coordination in adolescents with spastic diplegic cerebral palsy.
Standard Physical TherapyOther
Participants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fully Immersive Mixed Reality + Standard Physical Therapy | Experimental | Participants assigned to the experimental arm will receive fully immersive Mixed Reality (MR) using the Meta Quest Pro platform in combination with standardized physical therapy. The MR intervention will include interactive applications designed to improve balance and coordination. Standard physiotherapy will include balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, and strengthening exercises. Treatment will be provided three sessions per week for eight weeks. Receives: Device: Meta Quest Pro Mixed Reality System; Other: Standard Physical Therapy |
| Standard Physical Therapy | Active comparator | Participants assigned to the control arm will receive standardized physical therapy alone, including balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks. Receives: Other: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Coordination Scale (CCS)
The Comprehensive Coordination Scale (CCS) will be used to assess motor coordination in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on coordination.
Measured: Baseline, Week 4, and Week 8
Pediatric Balance Scale (PBS)
The Pediatric Balance Scale (PBS) will be used to evaluate functional balance in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on balance.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start12 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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. The experimental group will receive fully immersive Mixed Reality combined with standard physical therapy, while the control group will receive standard physical therapy alone throughout the study period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Yaseen Khattak, MS-PPT, Principal investigator, Ibadat International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685327
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/01/214
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available because of participant confidentiality, privacy considerations, and institutional policies.
Publications
Lee K, Oh H, Lee G. Fully Immersive Virtual Reality Game-Based Training for an Adolescent with Spastic Diplegic Cerebral Palsy: A Case Report. Children (Basel). 2022 Oct 3;9(10):1512. doi: 10.3390/children9101512.
PubMed 36291448
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Fully Immersive Mixed Reality Versus Standard Physical Therapy For Improving Balance And Coordination In Adolescent With Spastic Diplegic Cerebral Palsy" A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07685327
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/01/214
- Conditions
- Cerebral Palsy, Spastic Diplegic Cerebral Palsy
- Keywords
- Cerebral Palsy, Mixed Reality, Fully Immersive Mixed Reality, Pediatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 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.
This randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality (MR) combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10 to 19 years will be randomly assigned to one of two treatment groups. The intervention will be provided three times per week for eight weeks. Balance and coordination will be assessed before treatment, at four weeks, and after completion of the intervention using validated clinical outcome measures. The findings of this study may help determine whether immersive Mixed Reality can enhance rehabilitation outcomes in adolescents with cerebral palsy.
Detailed description
erebral palsy (CP) is one of the most common neurological disorders affecting movement, balance, posture, and coordination in children and adolescents. Spastic diplegic cerebral palsy is characterized by increased muscle tone predominantly affecting the lower limbs, resulting in impaired balance, reduced coordination, and limitations in functional mobility. Conventional physical therapy is considered the standard rehabilitation approach; however, patient motivation and treatment adherence may limit its effectiveness.
Mixed Reality (MR) technology provides an immersive and interactive rehabilitation environment that combines virtual and real-world elements, enabling repetitive, task-oriented training with real-time feedback. Such interventions may enhance motor learning, neuroplasticity, patient engagement, and functional recovery. Despite promising evidence regarding immersive virtual reality interventions, limited randomized controlled trials have compared fully immersive Mixed Reality with conventional physical therapy in adolescents with spastic diplegic cerebral palsy.
This single-blinded randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10-19 years who meet the eligibility criteria will be recruited and randomly allocated into two equal groups. Group A will receive fully immersive Mixed Reality training using the Meta Quest Pro platform in combination with standardized physical therapy, while Group B will receive standardized physical therapy alone. Both groups will receive treatment three sessions per week for eight weeks.
Outcome assessments will be performed at baseline, after four weeks, and after completion of the eight-week intervention. Balance will be evaluated using the Pediatric Balance Scale (PBS), while coordination will be assessed using the Comprehensive Coordination Scale (CCS). The findings of this study will provide evidence regarding the effectiveness of fully immersive Mixed Reality as an adjunct to conventional physical therapy and may contribute to improving rehabilitation strategies for adolescents with spastic diplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The experimental group will receive fully immersive Mixed Reality combined with standard physical therapy, while the control group will receive standard physical therapy alone throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Fully Immersive Mixed Reality + Standard Physical Therapy | Experimental | Device: Meta Quest Pro Mixed Reality System, Other: Standard Physical TherapyParticipants assigned to the experimental arm will receive fully immersive Mixed Reality (MR) using the Meta Quest Pro platform in combination with standardized physical therapy. The MR intervention will include interactive applications designed to improve balance and coordination. Standard physiotherapy will include balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, and strengthening exercises. Treatment will be provided three sessions per week for eight weeks. |
| Standard Physical Therapy | Active comparator | Other: Standard Physical TherapyParticipants assigned to the control arm will receive standardized physical therapy alone, including balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male and female participants.
- Adolescents aged 10 to 19 years.
- Clinically diagnosed with spastic diplegic cerebral palsy.
- Gross Motor Function Classification System (GMFCS) Levels I, II, or III.
- Pediatric Balance Scale (PBS) score greater than 35.
Key exclusion criteria (5 listed)
- Cognitive impairment (MMSE score <24).
- History of seizure disorders.
- Visual or hearing impairment that interferes with participation.
- Diagnosed psychological or psychiatric disorders.
- Any other medical condition that would prevent safe participation in the study.
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 |
|---|---|---|
| Meta Quest Pro Mixed Reality SystemParticipants will receive fully immersive Mixed Reality rehabilitation using the Meta Quest Pro headset in combination with standardized physical therapy. The intervention includes interactive applications such as Beat Saber, Ball Balance, Run and Cycling, Running Monkeys, and Back to Subway Surfer. Treatment will be provided three sessions per week for eight weeks to improve balance and coordination in adolescents with spastic diplegic cerebral palsy. | Device | Fully Immersive Mixed Reality + Standard Physical Therapy |
| Standard Physical TherapyParticipants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks. | Other | Fully Immersive Mixed Reality + Standard Physical Therapy, Standard Physical Therapy |
Primary outcome
Comprehensive Coordination Scale (CCS)
Time frame: Baseline, Week 4, and Week 8
The Comprehensive Coordination Scale (CCS) will be used to assess motor coordination in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on coordination.
Pediatric Balance Scale (PBS)
Time frame: Baseline, Week 4, and Week 8
The Pediatric Balance Scale (PBS) will be used to evaluate functional balance in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on balance.
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 Jul 2026.
- Results publication: PubMed 36291448Lee K, Oh H, Lee G. Fully Immersive Virtual Reality Game-Based Training for an Adolescent with Spastic Diplegic Cerebral Palsy: A Case Report. Children (Basel). 2022 Oct 3;9(10):1512. doi: 10.3390/children9101512.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because of participant confidentiality, privacy considerations, and institutional policies.
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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.
Muhammad Yaseen Khattak, MS-PPT principal investigator
Ibadat International University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Quest Pro Mixed Reality System and Standard Physical Therapy in people with Cerebral Palsy and Spastic Diplegic Cerebral Palsy, run by Ibadat International University, Islamabad 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 6 inclusion and 5 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 Jul 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 Muhammad Ashar Rafi, PhD* (923083407837, Ashar.rafi@uipt.iiui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Coordination Scale (CCS) (time frame: Baseline, Week 4, and Week 8). The study lists 2 primary outcomes in all. 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 NCT07685327, which also lists 1 linked publication.
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 Jul 2026.