Spastic Diplegic Cerebral PalsyNCT07736417
Effects of Core Stabilization Exercises on Postural Control in Spastic Diplegic CP Children
A study testing Exercise and Conventional in people with Spastic Diplegic Cerebral Palsy, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial summary
This randomized controlled trial will evaluate the effectiveness of a 12-week comprehensive core stabilization exercise program on balance, trunk control, and gross motor function in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Exercise and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2026to Nov 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with spastic diplegic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Levels II-III
- Stable medical management for at least 3 months prior to enrollment
- Ability to understand and follow simple verbal instructions
Who cannot join
- Fixed contracture or musculoskeletal deformities limiting exercise
- Orthopedic surgery or botulinum injection within the previous 3 months
- Uncontrolled epilepsy
- Severe visual impairment
- Participation in another rehabilitation intervention during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Core Stabilization Exercises on Postural Control in Spastic Diplegic CP Children: a Randomized Control Trial
This randomized controlled trial will evaluate the effectiveness of a 12-week comprehensive core stabilization exercise program on balance, trunk control, and gross motor function in children with spastic diplegic cerebral palsy. Outcome measures will be assessed at baseline and at the end of the intervention to determine changes following treatment.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Exercise, Conventional
- Keywords
- Balance, Trunk control, 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.
ExerciseOther
Progressive exercises targeting trunk muscle strength, stability, and postural control alongside conventional therapy
ConventionalOther
Stretching exercises, strengthening exercises, balance training, gait training, functional activities according to standard rehabilitation practice
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization Exercise Program with Conventional Therapy | Experimental | Participants will receive a structured core stabilization exercise program in addition to conventional physiotherapy. The program includes progressive exercises targeting trunk muscle activation, trunk control, and postural control, tailored to each participant's functional ability. Sessions will be conducted 3 times per week for 12 weeks. Receives: Other: Exercise; Other: Conventional |
| Conventional therapy | Active comparator | Participants will receive conventional physiotherapy consisting of stretching, strengthening, balance training, gait training, and functional exercises according to standard rehabilitation practice. Sessions will be conducted 3 times per week for 12 weeks. Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Pediatric Balance Scale (PBS) is a 14-item performance-based scale used to assess functional balance in children. Total scores range from 0 to 56, with higher scores indicating better balance.
Measured: Baseline and post 12 weeks of intervention
Trunk Control
Trunk Control Measurement Scale (TCMS) is a clinical scale used to evaluate static and dynamic trunk control and trunk coordination in children with cerebral palsy. Total scores range from 0 to 58, with higher scores indicating better trunk control.
Measured: Baseline and post 12 weeks of intervention
Secondary outcomes (1)
Gross Motor Function
Gross Motor Function Measure (GMFM-88) is a standardized observational measure used to assess gross motor function in children with cerebral palsy across activities such as lying, sitting, crawling, standing, and walking. Scores range from 0 to 100%, with higher scores indicating better gross motor function.
Measured: Baseline and post 12 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 posted30 Jul 2026
- Study start1 Aug 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shafaq Altaf, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736417
- Sponsor's protocol ID
- 064-26
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stabilization Exercises on Postural Control in Spastic Diplegic CP Children: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07736417
- Acronym / sponsor ID
- 064-26
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- Balance, Trunk control, Gross motor function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 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 will evaluate the effectiveness of a 12-week comprehensive core stabilization exercise program on balance, trunk control, and gross motor function in children with spastic diplegic cerebral palsy. Outcome measures will be assessed at baseline and at the end of the intervention to determine changes following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization Exercise Program with Conventional Therapy | Experimental | Other: Exercise, Other: ConventionalParticipants will receive a structured core stabilization exercise program in addition to conventional physiotherapy. The program includes progressive exercises targeting trunk muscle activation, trunk control, and postural control, tailored to each participant's functional ability. Sessions will be conducted 3 times per week for 12 weeks. |
| Conventional therapy | Active comparator | Other: ConventionalParticipants will receive conventional physiotherapy consisting of stretching, strengthening, balance training, gait training, and functional exercises according to standard rehabilitation practice. Sessions will be conducted 3 times per week for 12 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children diagnosed with spastic diplegic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Levels II-III
- Stable medical management for at least 3 months prior to enrollment
- Ability to understand and follow simple verbal instructions
Key exclusion criteria (5 listed)
- Fixed contracture or musculoskeletal deformities limiting exercise
- Orthopedic surgery or botulinum injection within the previous 3 months
- Uncontrolled epilepsy
- Severe visual impairment
- Participation in another rehabilitation intervention during the study period
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 |
|---|---|---|
| ExerciseProgressive exercises targeting trunk muscle strength, stability, and postural control alongside conventional therapy | Other | Core Stabilization Exercise Program with Conventional Therapy |
| ConventionalStretching exercises, strengthening exercises, balance training, gait training, functional activities according to standard rehabilitation practice | Other | Conventional therapy, Core Stabilization Exercise Program with Conventional Therapy |
Primary outcome
Balance
Time frame: Baseline and post 12 weeks of intervention
Pediatric Balance Scale (PBS) is a 14-item performance-based scale used to assess functional balance in children. Total scores range from 0 to 56, with higher scores indicating better balance.
Trunk Control
Time frame: Baseline and post 12 weeks of intervention
Trunk Control Measurement Scale (TCMS) is a clinical scale used to evaluate static and dynamic trunk control and trunk coordination in children with cerebral palsy. Total scores range from 0 to 58, with higher scores indicating better trunk control.
1 secondary outcome
Gross Motor Function
Time frame: Baseline and post 12 weeks of 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 1 Sep 2026.
- 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. 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 Exercise and Conventional in people with Spastic Diplegic Cerebral Palsy, run by Shifa Tameer-e-Millat 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 4 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: under way, not looking for participants, as of the sponsor's last update on 1 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 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?
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?
Balance (time frame: Baseline and post 12 weeks of intervention). 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?
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 1 Sep 2026.