Spastic Diplegic Cerebral PalsyNCT07747961
Effect of Virtual Reality Mediated Gamified Rehabilitation in Children With Spastic Diplegic Cerebral Palsy
A study testing Experimental Group in people with Spastic Diplegic Cerebral Palsy, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial aimed to evaluate the effectiveness of a Virtual Reality (VR)-mediated gamified rehabilitation program compared with conventional physical therapy in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2026to 30 Sep 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with spastic diplegic cerebral palsy.
- Age between 7-15 years.
- GMFCS Level II or III.
- Male and female participants.
- Able to follow verbal instructions. Exclusion Criteria
- Other neurological disorders.
Show all 13Show fewer
- Visual or hearing impairment.
- Other types of cerebral palsy.
- Severe cardiac disease.
- Orthopedic surgery within previous six months.
- Recent Botulinum toxin injection.
- Children taking antispastic or antiepileptic medication.
- Uncooperative participants.
Who cannot join
None listed.
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
Ibadat International University
Islamabad, 47000
Hafsah Arshad, PhD*, 03315165234, hafsah.arshad@uipt.iiui.edu.pk
Tazveena IIUI, MS (Paeds)
About this study
Official title: Effect of Virtual Reality Mediated Gamified Rehabilitation Program in Children With Spastic Diplegic Cerebral Palsy
This randomized controlled trial aimed to evaluate the effectiveness of a Virtual Reality (VR)-mediated gamified rehabilitation program compared with conventional physical therapy in children with spastic diplegic cerebral palsy. Forty-two children aged 7-15 years with Gross Motor Function Classification System (GMFCS) Levels II and III were recruited from Rafsan Neuro Rehab Center, Peshawar. Participants were randomly allocated into two equal groups. The intervention group received VR-based gamified rehabilitation using Xbox Kinect along with physiotherapy, while the control group received conventional physiotherapy only. Both groups completed 18 treatment sessions over six weeks. Outcome measures included the Timed Up and Go Test (TUG), Pediatric Balance Scale (PBS), Trunk Impairment Scale (TIS), and Gross Motor Function Classification System (GMFCS). The findings demonstrated that VR-mediated rehabilitation significantly improved functional mobility, balance, and trunk control compared with conventional therapy. The study concludes that VR-based rehabilitation is an effective, motivating, and clinically useful intervention for children with spastic diplegic cerebral palsy and may improve rehabilitation outcomes and functional independence.
Read the detailed description
Refer to complete thesis introduction, methodology and protocol.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Experimental Group, Control
- Keywords
- Spastic Diplegia, Gamified Rehabilitation, Gross Motor Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Also called Virtual Reality Mediated Gamified Rehabilitation Program
Virtual Reality Mediated Gamified Rehabilitation Program using Xbox Kinect combined with conventional physiotherapy.
ControlOther
Also called Conventional Physiotherapy
Conventional Physiotherapy Program
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Mediated Gamified Rehabilitation Program | Experimental | Virtual Reality Mediated Gamified Rehabilitation Program using Xbox Kinect combined with conventional physiotherapy. Receives: Other: Experimental Group |
| Conventional Physiotherapy Program | Active comparator | Conventional Physiotherapy Program Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test
Timed Up and Go Test score measures the time in seconds it takes a person to stand up from a chair, walk 3 meters (10 feet), turn around, walk back, and sit down.
Measured: At baseline and after 6 weeks
Pediatric Balance Scale
Pediatric Balance Scale examines functional balance in the context of everyday tasks in the pediatric population. It consists of 14 tasks.
Measured: baseline and after 6 weeks
Trunk Impairment Scale
Trunk Impairment Scale is a 17-item physical test. It measures trunk motor control, balance, and coordination in a sitting position.
Measured: Baseline and after 6 weeks
Secondary outcomes (1)
Gross Motor Function Classification System
Gross Motor Function Classification System is a five-level tool used to describe the self-initiated movement and mobility of children and youth with cerebral palsy.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Mar 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegic 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsah Arshad, Ibadat International University, Islamabad
- Investigators
- Hafsah Arshad, Principal investigator, Ibadat International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747961
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/02/243
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Mediated Gamified Rehabilitation Program in Children With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07747961
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/02/243
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- Spastic Diplegia, Gamified Rehabilitation, Gross Motor Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Aug 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 aimed to evaluate the effectiveness of a Virtual Reality (VR)-mediated gamified rehabilitation program compared with conventional physical therapy in children with spastic diplegic cerebral palsy. Forty-two children aged 7-15 years with Gross Motor Function Classification System (GMFCS) Levels II and III were recruited from Rafsan Neuro Rehab Center, Peshawar. Participants were randomly allocated into two equal groups. The intervention group received VR-based gamified rehabilitation using Xbox Kinect along with physiotherapy, while the control group received conventional physiotherapy only. Both groups completed 18 treatment sessions over six weeks. Outcome measures included the Timed Up and Go Test (TUG), Pediatric Balance Scale (PBS), Trunk Impairment Scale (TIS), and Gross Motor Function Classification System (GMFCS). The findings demonstrated that VR-mediated rehabilitation significantly improved functional mobility, balance, and trunk control compared with conventional therapy. The study concludes that VR-based rehabilitation is an effective, motivating, and clinically useful intervention for children with spastic diplegic cerebral palsy and may improve rehabilitation outcomes and functional independence.
Detailed description
Refer to complete thesis introduction, methodology and protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Mediated Gamified Rehabilitation Program | Experimental | Other: Experimental GroupVirtual Reality Mediated Gamified Rehabilitation Program using Xbox Kinect combined with conventional physiotherapy. |
| Conventional Physiotherapy Program | Active comparator | Other: ControlConventional Physiotherapy Program |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Diagnosed with spastic diplegic cerebral palsy.
- Age between 7-15 years.
- GMFCS Level II or III.
- Male and female participants.
- Able to follow verbal instructions. Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Experimental GroupAlso: Virtual Reality Mediated Gamified Rehabilitation ProgramVirtual Reality Mediated Gamified Rehabilitation Program using Xbox Kinect combined with conventional physiotherapy. | Other | Virtual Reality Mediated Gamified Rehabilitation Program |
| ControlAlso: Conventional PhysiotherapyConventional Physiotherapy Program | Other | Conventional Physiotherapy Program |
Primary outcome
Timed Up and Go Test
Time frame: At baseline and after 6 weeks
Timed Up and Go Test score measures the time in seconds it takes a person to stand up from a chair, walk 3 meters (10 feet), turn around, walk back, and sit down.
Pediatric Balance Scale
Time frame: baseline and after 6 weeks
Pediatric Balance Scale examines functional balance in the context of everyday tasks in the pediatric population. It consists of 14 tasks.
Trunk Impairment Scale
Time frame: Baseline and after 6 weeks
Trunk Impairment Scale is a 17-item physical test. It measures trunk motor control, balance, and coordination in a sitting position.
1 secondary outcome
Gross Motor Function Classification System
Time frame: Baseline and after 6 weeks
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 10 Aug 2026.
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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.
Hafsah Arshad 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 Experimental Group in people with 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 13 inclusion and 0 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 10 Aug 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 Hafsah Arshad, Phd* (03315165234, hafsah.arshad@uipt.iiui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: At baseline and after 6 weeks). 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 10 Aug 2026.