Cerebral Palsy (CP)NCT07129785
Dynamic Surface Exercise Training and Static Surface Exercise Training in Cerebral Palsy Children
A study testing Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) in people with Cerebral Palsy (CP) and Spastic Diplegia Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
Trial summary
This randomized clinical trial aims to compare the effects of Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) on balance and gross motor function in children with spastic diplegic cerebral palsy (CP) aged 6-12 years, classified at Gross Motor Function Classification System (GMFCS)… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Spastic Diplegia Cerebral Palsy, Gross Motor Functions
- What is being tested?
- Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2025to 29 Aug 2025
- 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
- Children diagnosed with spastic diplegic CP between age 6-12 years (Reddy \& Balaji, 2020).
- Both male and female gender (Reddy \& Balaji, 2020).
- Who were able to follow verbal commands.
- Children having level III and IV of Gross Motor Function Classification System (GMFCS) (Reddy \& Balaji, 2020).
Who cannot join
- CP Child who were reluctant to cooperate.
- CP child having visual or intellectual impairments (Reddy \& Balaji, 2020).
- Who were on Antiepileptic medications (Reddy \& Balaji, 2020).
- CP child having any cardiac or chest anomalies and hearing deficits.
- Exercise intolerance and any recent orthopedic surgery will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical trial aims to compare the effects of Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) on balance and gross motor function in children with spastic diplegic cerebral palsy (CP) aged 6-12 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV. CP is the most common motor disability of childhood, characterized by non-progressive disturbances to the developing brain, leading to impairments in movement, posture, and functional independence. Balance deficits and gross motor limitations significantly impact daily activities and quality of life in these children.
Dynamic surfaces such as Swiss balls, bolsters, and platform swings provide postural perturbations that challenge vestibular, proprioceptive, and visual systems, potentially enhancing trunk control, postural stability, and adaptive responses. In contrast, static surface exercises emphasize controlled strength, postural alignment, and functional task performance on stable platforms such as mats or benches.
Read more
Fifty participants meeting the inclusion criteria will be randomly allocated into two equal groups. The DSET group will receive 60-minute sessions, four days per week for six weeks, involving multi-planar trunk activation, optimal arousal activities, and dynamic balance tasks on unstable surfaces. The SSET group will perform equivalent-duration exercises on stable surfaces, focusing on functional reaching, transfers, and static/dynamic balance.
Primary outcomes are Gross Motor Function Measure-66 (GMFM-66) and Pediatric Balance Scale (PBS), assessed at baseline, week 3, and week 6 by a blinded evaluator. Statistical analyses will compare within- and between-group changes. Findings will help identify the more effective approach for improving functional outcomes in children with CP, guiding evidence-based pediatric neurorehabilitation strategies.
Read the detailed description
Cerebral palsy (CP) encompasses a group of permanent disorders affecting movement and posture due to non-progressive disturbances in the developing fetal or infant brain. Spastic diplegic CP often results in muscle tone abnormalities, postural instability, and reduced gross motor function. These impairments hinder participation in daily activities and increase fall risk. Motor deficits are closely linked to postural control, which depends on integrated sensory input from visual, vestibular, and somatosensory systems.
Dynamic surface training introduces controlled instability through tools like Swiss balls, bolsters, trampolines, and platform swings. This variability promotes adaptive postural adjustments and multi-planar muscle activation, potentially enhancing gross motor skills and balance beyond what is achieved with stable surfaces. Static surface training, using mats, benches, or floors, emphasizes strength, posture, and functional movement without additional instability challenges.
This single-center, single-blinded, randomized clinical trial will recruit 50 children aged 6-12 years with spastic diplegic CP (GMFCS III-IV) who can follow verbal commands and meet other inclusion criteria. Participants will be randomly allocated to:
Group A (DSET): 6-week program, 60 min/day, 4 days/week. Activities include optimal arousal (active/passive bouncing), high sitting with one-hand/both-hands reaching, sit-to-stand transitions, multi-directional reaching, trunk activation, and dynamic balance exercises on unstable surfaces.
Group B (SSET): 6-week program, 60 min/day, 4 days/week. Exercises include transfers between sitting and quadruped, high sitting on a bench with functional reaching, static/dynamic standing balance, and trunk activation tasks on stable surfaces.
Outcome Measures:
Primary: GMFM-66 (gross motor function), PBS (balance performance).
Secondary: Functional improvement trends over time.
Assessments will occur at baseline, week 3, and week 6, conducted by blinded assessors. Data will be analyzed using SPSS v24, applying parametric or non-parametric tests based on data normality, with significance set at p ≤ 0.05.
Ethical approval has been obtained from the Institutional Research Ethics Board of the University of Lahore. Written informed consent will be obtained from parents/guardians. Participant confidentiality will be maintained, and participation will be voluntary.
The study is designed to address gaps in existing literature, including limited sample sizes, lack of long-term follow-up, and variability in intervention protocols. Results will provide clinically relevant evidence on whether unstable or stable surface training is more effective for improving motor function and balance in children with spastic diplegic CP, supporting optimized rehabilitation planning.
- Being tested
- Dynamic Surface Exercise Training (DSET), Static Surface Exercise Training (SSET)
- Keywords
- Dynamic Surface Exercise Training, Static Surface Exercise Training, Swiss Ball Therapy, Pediatric Neurorehabilitation, Postural Control, Gross Motor Function Measure, Pediatric Balance Scale, Trunk Control, Motor Skill Development, Unstable Surface Training, Stable Surface Training
- Medical subject headings
- Cerebral Palsy, Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Surface Exercise Training (DSET)Behavioural
DSET involves performing multi-planar trunk activation, postural control, and balance exercises on unstable surfaces such as Swiss/gym balls, bolsters, trampolines, and platform swings. Each session lasts 60 minutes, four times per week, for six weeks. Activities include optimal arousal (bouncing), high sitting with one- and two-hand reaching, sit-to-stand transitions, and lateral weight-shifting. The unstable surface provides postural perturbations that stimulate vestibular, proprioceptive, and visual systems to improve gross motor function and balance in children with spastic diplegic cerebral palsy.
Static Surface Exercise Training (SSET)Behavioural
SSET consists of functional strength, posture, and balance exercises performed on stable surfaces such as mats, benches, or stools. Each session lasts 60 minutes, four times per week, for six weeks. Activities include transfers between sitting and quadruped, high sitting with functional reaching, static and dynamic standing balance, ball-catching and kicking, and trunk activation tasks. Exercises aim to enhance gross motor function and balance through controlled, stable postural activities in children with spastic diplegic cerebral palsy.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Surface Exercise Training (DSET) | Experimental | Participants in this group will receive Dynamic Surface Exercise Training for 60 minutes per session, four days per week, for six weeks. Activities include optimal arousal (active/passive bouncing) on Swiss/gym balls or trampolines, multi-planar trunk activation, high sitting with one- and two-hand reaching, sit-to-stand transitions, and dynamic balance tasks performed on unstable surfaces such as bolsters and platform swings. Exercises are designed to challenge vestibular, proprioceptive, and visual systems to enhance gross motor function and balance. Receives: Behavioral: Dynamic Surface Exercise Training (DSET) |
| Static Surface Exercise Training (SSET) | Active comparator | Participants in this group will receive Static Surface Exercise Training for 60 minutes per session, four days per week, for six weeks. Activities include transfers between sitting and quadruped, high sitting on a bench with functional reaching, static and dynamic balance in standing, ball-catching and kicking, and trunk activation tasks performed on stable surfaces such as mats or benches. Exercises aim to improve gross motor function and balance through controlled, stable postural activities. Receives: Behavioral: Static Surface Exercise Training (SSET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-66 (GMFM-66) Score
The GMFM-66 is a standardized observational instrument used to assess gross motor function in children with cerebral palsy. It evaluates the child's ability to perform various motor tasks across lying, sitting, crawling, standing, and walking dimensions. Scores range from 0 to 100, with higher scores indicating better motor performance. Assessments will be conducted by a blinded evaluator at baseline, week 3, and week 6 to determine within- and between-group changes following Dynamic Surface Exercise Training or Static Surface Exercise Training.
Measured: Baseline, Week 3, Week 6
Pediatric Balance Scale (PBS) Score
The PBS is a 14-item scale adapted from the Berg Balance Scale to assess static, dynamic, and functional balance in children aged 3-13 years. Each item is scored from 0 to 4, with total scores ranging from 0 to 56. Higher scores reflect better balance and postural control. A blinded evaluator will assess participants at baseline, week 3, and week 6 to measure improvement in balance performance after the assigned intervention.
Measured: Baseline, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Feb 2025
- Primary completion22 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iqra Rashid, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129785
- Sponsor's protocol ID
- UOL/IREB/25/09/0036
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Surface Exercise Training and Static Surface Exercise Training in Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT07129785
- Acronym / sponsor ID
- UOL/IREB/25/09/0036
- Keywords
- Dynamic Surface Exercise Training, Static Surface Exercise Training, Swiss Ball Therapy, Pediatric Neurorehabilitation, Postural Control, Gross Motor Function Measure, Pediatric Balance Scale, Trunk Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 19 Aug 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.
This randomized clinical trial aims to compare the effects of Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) on balance and gross motor function in children with spastic diplegic cerebral palsy (CP) aged 6-12 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV. CP is the most common motor disability of childhood, characterized by non-progressive disturbances to the developing brain, leading to impairments in movement, posture, and functional independence. Balance deficits and gross motor limitations significantly impact daily activities and quality of life in these children.
Dynamic surfaces such as Swiss balls, bolsters, and platform swings provide postural perturbations that challenge vestibular, proprioceptive, and visual systems, potentially enhancing trunk control, postural stability, and adaptive responses. In contrast, static surface exercises emphasize controlled strength, postural alignment, and functional task performance on stable platforms such as mats or benches.
Fifty participants meeting the inclusion criteria will be randomly allocated into two equal groups. The DSET group will receive 60-minute sessions, four days per week for six weeks, involving multi-planar trunk activation, optimal arousal activities, and dynamic balance tasks on unstable surfaces. The SSET group will perform equivalent-duration exercises on stable surfaces, focusing on functional reaching, transfers, and static/dynamic balance.
Primary outcomes are Gross Motor Function Measure-66 (GMFM-66) and Pediatric Balance Scale (PBS), assessed at baseline, week 3, and week 6 by a blinded evaluator. Statistical analyses will compare within- and between-group changes. Findings will help identify the more effective approach for improving functional outcomes in children with CP, guiding evidence-based pediatric neurorehabilitation strategies.
Detailed description
Cerebral palsy (CP) encompasses a group of permanent disorders affecting movement and posture due to non-progressive disturbances in the developing fetal or infant brain. Spastic diplegic CP often results in muscle tone abnormalities, postural instability, and reduced gross motor function. These impairments hinder participation in daily activities and increase fall risk. Motor deficits are closely linked to postural control, which depends on integrated sensory input from visual, vestibular, and somatosensory systems.
Dynamic surface training introduces controlled instability through tools like Swiss balls, bolsters, trampolines, and platform swings. This variability promotes adaptive postural adjustments and multi-planar muscle activation, potentially enhancing gross motor skills and balance beyond what is achieved with stable surfaces. Static surface training, using mats, benches, or floors, emphasizes strength, posture, and functional movement without additional instability challenges.
This single-center, single-blinded, randomized clinical trial will recruit 50 children aged 6-12 years with spastic diplegic CP (GMFCS III-IV) who can follow verbal commands and meet other inclusion criteria. Participants will be randomly allocated to:
Group A (DSET): 6-week program, 60 min/day, 4 days/week. Activities include optimal arousal (active/passive bouncing), high sitting with one-hand/both-hands reaching, sit-to-stand transitions, multi-directional reaching, trunk activation, and dynamic balance exercises on unstable surfaces.
Group B (SSET): 6-week program, 60 min/day, 4 days/week. Exercises include transfers between sitting and quadruped, high sitting on a bench with functional reaching, static/dynamic standing balance, and trunk activation tasks on stable surfaces.
Outcome Measures:
Primary: GMFM-66 (gross motor function), PBS (balance performance).
Secondary: Functional improvement trends over time.
Assessments will occur at baseline, week 3, and week 6, conducted by blinded assessors. Data will be analyzed using SPSS v24, applying parametric or non-parametric tests based on data normality, with significance set at p ≤ 0.05.
Ethical approval has been obtained from the Institutional Research Ethics Board of the University of Lahore. Written informed consent will be obtained from parents/guardians. Participant confidentiality will be maintained, and participation will be voluntary.
The study is designed to address gaps in existing literature, including limited sample sizes, lack of long-term follow-up, and variability in intervention protocols. Results will provide clinically relevant evidence on whether unstable or stable surface training is more effective for improving motor function and balance in children with spastic diplegic CP, supporting optimized rehabilitation planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Surface Exercise Training (DSET) | Experimental | Behavioral: Dynamic Surface Exercise Training (DSET)Participants in this group will receive Dynamic Surface Exercise Training for 60 minutes per session, four days per week, for six weeks. Activities include optimal arousal (active/passive bouncing) on Swiss/gym balls or trampolines, multi-planar trunk activation, high sitting with one- and two-hand reaching, sit-to-stand transitions, and dynamic balance tasks performed on unstable surfaces such as bolsters and platform swings. Exercises are designed to challenge vestibular, proprioceptive, and visual systems to enhance gross motor function and balance. |
| Static Surface Exercise Training (SSET) | Active comparator | Behavioral: Static Surface Exercise Training (SSET)Participants in this group will receive Static Surface Exercise Training for 60 minutes per session, four days per week, for six weeks. Activities include transfers between sitting and quadruped, high sitting on a bench with functional reaching, static and dynamic balance in standing, ball-catching and kicking, and trunk activation tasks performed on stable surfaces such as mats or benches. Exercises aim to improve gross motor function and balance through controlled, stable postural activities. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children diagnosed with spastic diplegic CP between age 6-12 years (Reddy \& Balaji, 2020).
- Both male and female gender (Reddy \& Balaji, 2020).
- Who were able to follow verbal commands.
- Children having level III and IV of Gross Motor Function Classification System (GMFCS) (Reddy \& Balaji, 2020).
Key exclusion criteria (5 listed)
- CP Child who were reluctant to cooperate.
- CP child having visual or intellectual impairments (Reddy \& Balaji, 2020).
- Who were on Antiepileptic medications (Reddy \& Balaji, 2020).
- CP child having any cardiac or chest anomalies and hearing deficits.
- Exercise intolerance and any recent orthopedic surgery will also be excluded from 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 |
|---|---|---|
| Dynamic Surface Exercise Training (DSET)DSET involves performing multi-planar trunk activation, postural control, and balance exercises on unstable surfaces such as Swiss/gym balls, bolsters, trampolines, and platform swings. Each session lasts 60 minutes, four times per week, for six weeks. Activities include optimal arousal (bouncing), high sitting with one- and two-hand reaching, sit-to-stand transitions, and lateral weight-shifting. The unstable surface provides postural perturbations that stimulate vestibular, proprioceptive, and visual systems to improve gross motor function and balance in children with spastic diplegic cerebral palsy. | Behavioural | Dynamic Surface Exercise Training (DSET) |
| Static Surface Exercise Training (SSET)SSET consists of functional strength, posture, and balance exercises performed on stable surfaces such as mats, benches, or stools. Each session lasts 60 minutes, four times per week, for six weeks. Activities include transfers between sitting and quadruped, high sitting with functional reaching, static and dynamic standing balance, ball-catching and kicking, and trunk activation tasks. Exercises aim to enhance gross motor function and balance through controlled, stable postural activities in children with spastic diplegic cerebral palsy. | Behavioural | Static Surface Exercise Training (SSET) |
Primary outcome
Gross Motor Function Measure-66 (GMFM-66) Score
Time frame: Baseline, Week 3, Week 6
The GMFM-66 is a standardized observational instrument used to assess gross motor function in children with cerebral palsy. It evaluates the child's ability to perform various motor tasks across lying, sitting, crawling, standing, and walking dimensions. Scores range from 0 to 100, with higher scores indicating better motor performance. Assessments will be conducted by a blinded evaluator at baseline, week 3, and week 6 to determine within- and between-group changes following Dynamic Surface Exercise Training or Static Surface Exercise Training.
Pediatric Balance Scale (PBS) Score
Time frame: Baseline, Week 3, Week 6
The PBS is a 14-item scale adapted from the Berg Balance Scale to assess static, dynamic, and functional balance in children aged 3-13 years. Each item is scored from 0 to 4, with total scores ranging from 0 to 56. Higher scores reflect better balance and postural control. A blinded evaluator will assess participants at baseline, week 3, and week 6 to measure improvement in balance performance after the assigned intervention.
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 3 Sep 2025.
- 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 Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) in people with Cerebral Palsy (CP) and Spastic Diplegia Cerebral Palsy, run by University of Lahore 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: finished, as of the sponsor's last update on 3 Sep 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?
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-66 (GMFM-66) Score (time frame: Baseline, Week 3, Week 6). 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 3 Sep 2025.