Spastic Diplegic Cerebral PalsyNCT07712315
Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy
A study testing Experimental Group A received Vestibular Stimulation along with Conventional therapy. in people with Spastic Diplegic Cerebral Palsy, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
This was a RCT to determine and compare the effects of vestibular stimulation in addition to conventional physical therapy on gross motor function and mobility in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Experimental Group A received Vestibular Stimulation along with Conventional therapy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Jan 2026to 3 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- • Participants with age limit of 6-12 years
- Diagnosed cases of Spastic Diplegic Cerebral Palsy by Pediatric neurologist
- Both genders (male/female)
- Participants with GMFCS Level I-III
- Participants with Grade I spasticity, Modified Ashworth Scale (MAS) • Participants able to understand and follow basic commands.
Who cannot join
- • Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past six months
- Children with any surgical procedure of the spine or lower limbs or Botox treatment in the last 6 months
- Children with any visual or hearing impairment
- Children having any fixed deformity, contracture or fracture limiting participation in therapy
- Patients having VP shunt
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ibadat International University, Islamabad
Mansehra, KPK, 25000
About this study
This was a RCT to determine and compare the effects of vestibular stimulation in addition to conventional physical therapy on gross motor function and mobility in children with spastic diplegic cerebral palsy.
Read the detailed description
In this RCT , Experimental Group received Vestibular Stimulation along with Conventional therapy. Control Group received Conventional physiotherapy alone.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Experimental Group A received Vestibular Stimulation along with Conventional therapy., Control Group B received Conventional physiotherapy alone.
- 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 Group A received Vestibular Stimulation along with Conventional therapy.Other
Experimental Group A received Vestibular Stimulation along with Conventional therapy. Vestibular stimulation included Multi-directional swinging , Trampoline jumps , Rocking movement , Gaze stabilization exercises , Visual pursuit exercises , Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
Control Group B received Conventional physiotherapy alone.Other
Control Group B received Conventional physiotherapy alone which includes Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A received Vestibular Stimulation along with Conventional therapy. | Experimental | Participants in this group received Vestibular Stimulation along with Conventional therapy. Receives: Other: Experimental Group A received Vestibular Stimulation along with Conventional therapy. |
| Control Group B received Conventional physiotherapy alone. | Active comparator | Participants in this group received Conventional physiotherapy alone Receives: Other: Control Group B received Conventional physiotherapy alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM-88)
Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where:
- 0 shows that the participant does not begin the activity
- 1 show that the participant initiates the activity (completes < 10% of the activity)
- 2 show that the participant completes the activity partially (performed from 10 to 99% of the activity)
- 3 show that the participant finishes the activity (100%)
- NT show that the participant was not tested For each item, maximum of three trials is permitted and the best one will be recorded.
Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions.
Measured: Assessment was performed at baseline and after 6 weeks of intervention.
10-Meter Walk Test (10MWT)
The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy. The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section. The time taken to reach the midpoint of the 10 m walk will be recorded.
Measured: Assessment was performed at baseline and after 6 weeks of intervention
Timed Up and Go (TUG) test
Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow:
- <10 seconds = normal
- < 20 seconds = good mobility, can go out alone, mobile without a gait aid.
- < 30 seconds = problems, cannot go outside alone, requires a gait aid.
Measured: Assessment was performed at baseline and after 6 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start11 Jan 2026
- Primary completion30 Jun 2026
- Study completion3 Jul 2026
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712315
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/01/215
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07712315
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/01/215
- Conditions
- Spastic Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 11 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 17 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 was a RCT to determine and compare the effects of vestibular stimulation in addition to conventional physical therapy on gross motor function and mobility in children with spastic diplegic cerebral palsy.
Detailed description
In this RCT , Experimental Group received Vestibular Stimulation along with Conventional therapy. Control Group received Conventional physiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A received Vestibular Stimulation along with Conventional therapy. | Experimental | Other: Experimental Group A received Vestibular Stimulation along with Conventional therapy.Participants in this group received Vestibular Stimulation along with Conventional therapy. |
| Control Group B received Conventional physiotherapy alone. | Active comparator | Other: Control Group B received Conventional physiotherapy alone.Participants in this group received Conventional physiotherapy alone |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Participants with age limit of 6-12 years
Key exclusion criteria (5 listed)
- • Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past 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 |
|---|---|---|
| Experimental Group A received Vestibular Stimulation along with Conventional therapy.Experimental Group A received Vestibular Stimulation along with Conventional therapy. Vestibular stimulation included Multi-directional swinging , Trampoline jumps , Rocking movement , Gaze stabilization exercises , Visual pursuit exercises , Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions. | Other | Experimental Group A received Vestibular Stimulation along with Conventional therapy. |
| Control Group B received Conventional physiotherapy alone.Control Group B received Conventional physiotherapy alone which includes Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions. | Other | Control Group B received Conventional physiotherapy alone. |
Primary outcome
Gross Motor Function Measure (GMFM-88)
Time frame: Assessment was performed at baseline and after 6 weeks of intervention.
Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where: * 0 shows that the participant does not begin the activity * 1 show that the participant initiates the activity (completes < 10% of the activity) * 2 show that the participant completes the activity partially (performed from 10 to 99% of the activity) * 3 show that the participant finishes the activity (100%) * NT show that the participant was not tested For each item, maximum of three trials is permitted and the best one will be recorded. Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions.
10-Meter Walk Test (10MWT)
Time frame: Assessment was performed at baseline and after 6 weeks of intervention
The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy. The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section. The time taken to reach the midpoint of the 10 m walk will be recorded.
Timed Up and Go (TUG) test
Time frame: Assessment was performed at baseline and after 6 weeks of intervention.
Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow: * <10 seconds = normal * < 20 seconds = good mobility, can go out alone, mobile without a gait aid. * < 30 seconds = problems, cannot go outside alone, requires a gait aid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Spastic Diplegic Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
RecruitingPhase 4
Addiction Potential of Very Low Nicotine Filtered Little Cigars
Smoking (Tobacco) Addiction
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 A received Vestibular Stimulation along with Conventional therapy. 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 5 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: finished, as of the sponsor's last update on 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM-88) (time frame: Assessment was performed at baseline and after 6 weeks of intervention.). 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 17 Jul 2026.