Child, OnlyNCT07244159
Effects of Dynamic Surface Exercise Training in Children With Diplegic Cerebral Palsy
A study testing Dynamic surface exercise training and Standard physiotherapy Training in people with Child, Only, run by Riphah International University at 1 site in Pakistan.
Trial summary
Data will be collected after the approval of synopsis a total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Child, Only
- What is being tested?
- Dynamic surface exercise training and Standard physiotherapy Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 30 Jan 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 5 and 8 years of both genders
- Classification as level III and IV on the Gross Motor Function Classification system (GMFCS)
Who cannot join
- • Any orthopedic surgery or botulinum toxin injection in the past 6 months.
- Refusal by the parents to participate.
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
Hafiza Iram Batool
Lahore, Punjab Province, 54000
Muhammad Asif Javed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Dynamic Surface Exercise Training on Functional Mobility, Balance and Coordination in Children With Diplegic Cerebral Palsy
Data will be collected after the approval of synopsis a total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.
Read the detailed description
This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times).
This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set. On floor, standing: throwing and catching the ball from different direction, 10 times each side, 1 set Gross motor function measure-88 and pediatric balance scale and time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention
- Conditions
- Child, Only
- Being tested
- Dynamic surface exercise training, Standard physiotherapy Training
- Keywords
- Diplegic cerebral palsy, Dynamic surface exercise training, Balance, Coordination, Gross Motor Function Measure (GMFM)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic surface exercise trainingOther
This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times.
Standard physiotherapy TrainingOther
This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions) Receives: Other: Dynamic surface exercise training |
| Group B | Active comparator | This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set Receives: Other: Standard physiotherapy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM)
Balance Scale (PBS) will be the outcome measures use in this trial. GMFM-88 has excellent relative reliability of excellent (Intraclass correlation coefficient (ICC) = 0.952-1.000)
Measured: baseline, 1st week and 6th week
Pediatric Berg Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children
Measured: baseline, 1st week and 6th week
Time up and go test
Reliability of TUG test was high, with ICC of 0.99 for within-session reliability and 0.99 for test-retest reliability
Measured: baseline, 1st week and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start22 Oct 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 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 Child, OnlyStudies 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
- This is a randomized clinical trial,total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Iram Batool, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244159
- Sponsor's protocol ID
- REC/RCR&AHS/HAFIZA IRAM BATOOL
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct.
PubMed 36415346
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Surface Exercise Training on Functional Mobility, Balance and Coordination in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07244159
- Acronym / sponsor ID
- REC/RCR&AHS/HAFIZA IRAM BATOOL
- Conditions
- Child, Only
- Keywords
- Diplegic cerebral palsy, Dynamic surface exercise training, Balance, Coordination, Gross Motor Function Measure (GMFM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 24 Nov 2025 (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.
Data will be collected after the approval of synopsis a total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.
Detailed description
This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times).
This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set. On floor, standing: throwing and catching the ball from different direction, 10 times each side, 1 set Gross motor function measure-88 and pediatric balance scale and time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial,total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Dynamic surface exercise trainingThis group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions) |
| Group B | Active comparator | Other: Standard physiotherapy TrainingThis group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 5 and 8 years of both genders
- Classification as level III and IV on the Gross Motor Function Classification system (GMFCS)
Key exclusion criteria (2 listed)
- • Any orthopedic surgery or botulinum toxin injection in the past 6 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 |
|---|---|---|
| Dynamic surface exercise trainingThis group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times. | Other | Group A |
| Standard physiotherapy TrainingThis group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. | Other | Group B |
Primary outcome
Gross Motor Function Measure (GMFM)
Time frame: baseline, 1st week and 6th week
Balance Scale (PBS) will be the outcome measures use in this trial. GMFM-88 has excellent relative reliability of excellent (Intraclass correlation coefficient (ICC) = 0.952-1.000)
Pediatric Berg Balance Scale
Time frame: baseline, 1st week and 6th week
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children
Time up and go test
Time frame: baseline, 1st week and 6th week
Reliability of TUG test was high, with ICC of 0.99 for within-session reliability and 0.99 for test-retest reliability
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 24 Nov 2025.
- Background: PubMed 36415346Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct.
- 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.
Hafiza Iram Batool, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic surface exercise training and Standard physiotherapy Training in people with Child, Only, run by Riphah International 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 2 inclusion and 2 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 24 Nov 2025. 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 IMRAN AMJAD, Phd (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM) (time frame: baseline, 1st week and 6th week). 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?
On the ClinicalTrials.gov record for NCT07244159, 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 24 Nov 2025.