Cerebral Palsy Spastic DiplegiaNCT05946096
Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy
A study testing Dynamic surface exercise training and conventional physical therapy in people with Cerebral Palsy Spastic Diplegia, run by Ayesha Hameed at 1 site in Pakistan.
Trial summary
The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Dynamic surface exercise training and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 1 Dec 2023
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diplegic children having Cerebral Palsy
- Children of age 5 - 12 years
- Children of GMFCS- E \&R level III and IV
- Children who can follow verbal commands
Who cannot join
- Children with epileptic fits
- Children presenting with lower limb muscular contractures
- Children with scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.
Read the detailed description
A clinical trial was conducted to assess the impact dynamic surface exercise training on gross motor and trunk control of children with spastic diplegic cerebral palsy. The trial enrolled 38 children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. Children were randomly assigned to either the DSET or conventional physiotherapy training groups. Both groups underwent 60-minute vigorous exercise program four days a week for two months. The trunk control measurement scale was used to assess trunk control, while the GMFM-88 was used to assess gross motor function. Trunk control and gross motor function scores were obtained at the beginning, the fourth week, and the eighth week.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Dynamic surface exercise training, conventional physical therapy
- Keywords
- trunk control, dynamic surface exercise therapy, gross motor
- 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
Dynamic surface exercise training involves a set of exercises that are performed on various dynamic surfaces like gym ball and vestibular swing. All these exercise provide optimal arousal as they provide proprioceptive and vestibular stimulus. This group received a set of exercises on various dynamic surfaces.These exercises were implemented for 60 minutes for four days a week for two months.And it was observed how these exercises impacted gross motor function and trunk control of children with diplegic cerebral palsy of GMFCS level 3 and 4
conventional physical therapyOther
conventional physical therapy based on NDT involves a set of exercises that mostly include positioning exercises such as quadruped, side sitting, reaching sideways and overhead in sitting and catch and throw activities.
| Study group | Role | What they receive |
|---|---|---|
| dynamic surface exercise training group | Experimental | This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received a set of exercises on various dynamic surfaces along with routine physical therapy. This group underwent a 60-minutes vigorous exercise program four days a week for two months Receives: Other: Dynamic surface exercise training |
| conventional physical therapy group | Active comparator | This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received only conventional physical therapy which is based upon principles of NDT. This group underwent a 60-minutes vigorous exercise program four days a week for two months. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measure- 88
The Gross Motor Function Measure (GMFM 88) is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.
It explores five areas of motor ability, which are known as dimensions:
- Lying and rolling B) Sitting C) Crawling and kneeling D) Standing E) Walking, running and jumping
Measured: change in baseline scores and 8th week scores
trunk control measurement scale
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. total score is 58 . low score means severely impaired trunk control and a high score shows better trunk control
Measured: change in baseline scores and 8th week scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- 38 children with CP were randomly assigned to 2 groups. 1 group was interventional group and second group was control group. Both the groups were provided with therapy ( interventional group was provided with conventional therapy and intervention. control group was provided with conventional therapy only) and results were analyzed based on performance of both groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayesha Hameed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayesha Hameed, University of Lahore
- Investigators
- Ayesha Hameed, DPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946096
- Sponsor's protocol ID
- ULahore123
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2023
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05946096
- Acronym / sponsor ID
- ULahore123
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- trunk control, dynamic surface exercise therapy, gross motor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ayesha HameedUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Jul 2023 (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.
The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.
Detailed description
A clinical trial was conducted to assess the impact dynamic surface exercise training on gross motor and trunk control of children with spastic diplegic cerebral palsy. The trial enrolled 38 children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. Children were randomly assigned to either the DSET or conventional physiotherapy training groups. Both groups underwent 60-minute vigorous exercise program four days a week for two months. The trunk control measurement scale was used to assess trunk control, while the GMFM-88 was used to assess gross motor function. Trunk control and gross motor function scores were obtained at the beginning, the fourth week, and the eighth week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 38 children with CP were randomly assigned to 2 groups. 1 group was interventional group and second group was control group. Both the groups were provided with therapy ( interventional group was provided with conventional therapy and intervention. control group was provided with conventional therapy only) and results were analyzed based on performance of both groups.
| Arm | Type | Receives |
|---|---|---|
| dynamic surface exercise training group | Experimental | Other: Dynamic surface exercise trainingThis group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received a set of exercises on various dynamic surfaces along with routine physical therapy. This group underwent a 60-minutes vigorous exercise program four days a week for two months |
| conventional physical therapy group | Active comparator | Other: conventional physical therapyThis group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received only conventional physical therapy which is based upon principles of NDT. This group underwent a 60-minutes vigorous exercise program four days a week for two months. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diplegic children having Cerebral Palsy
- Children of age 5 - 12 years
- Children of GMFCS- E \&R level III and IV
- Children who can follow verbal commands
Key exclusion criteria (3 listed)
- Children with epileptic fits
- Children presenting with lower limb muscular contractures
- Children with scoliosis
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 trainingDynamic surface exercise training involves a set of exercises that are performed on various dynamic surfaces like gym ball and vestibular swing. All these exercise provide optimal arousal as they provide proprioceptive and vestibular stimulus. This group received a set of exercises on various dynamic surfaces.These exercises were implemented for 60 minutes for four days a week for two months.And it was observed how these exercises impacted gross motor function and trunk control of children with diplegic cerebral palsy of GMFCS level 3 and 4 | Other | dynamic surface exercise training group |
| conventional physical therapyconventional physical therapy based on NDT involves a set of exercises that mostly include positioning exercises such as quadruped, side sitting, reaching sideways and overhead in sitting and catch and throw activities. | Other | conventional physical therapy group |
Primary outcome
Gross motor function measure- 88
Time frame: change in baseline scores and 8th week scores
The Gross Motor Function Measure (GMFM 88) is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy. It explores five areas of motor ability, which are known as dimensions: A) Lying and rolling B) Sitting C) Crawling and kneeling D) Standing E) Walking, running and jumping
trunk control measurement scale
Time frame: change in baseline scores and 8th week scores
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. total score is 58 . low score means severely impaired trunk control and a high score shows better trunk control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy Spastic Diplegia
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
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Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy
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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.
Ayesha Hameed, DPT principal investigator
University of Lahore
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 conventional physical therapy in people with Cerebral Palsy Spastic Diplegia, run by Ayesha Hameed 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 3 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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?
Results are not available in the source record.
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- 88 (time frame: change in baseline scores and 8th week scores). 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 14 Jul 2023.