Cerebral PalsyNCT06460727
Task Oriented Training on Static Versus Dynamic Surface on Balance in CP
A study testing task oriented exercise training on dynamic surface and task oriented exercise training on static surface in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement which are due to a non-progressive interference, lesion, or abnormality of the developing/immature brain . Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- task oriented exercise training on dynamic surface and task oriented exercise training on static surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jun 2024to 15 Aug 2024
- 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 with cerebral palsy
- Age between 6 to 12 years
- Children with GMFCS level I and II
Who cannot join
- CP children who has any musculoskeletal deformity in any of two limb
- Visual auditory, perceptual and auditory deficits, seizures or epilepsy
- Having botulinum toxin injections
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Task Oriented Exercice Training on Static Versus Dynamic Surface on Functional Mobility and Balance in Children With Cerebral Palsy
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement which are due to a non-progressive interference, lesion, or abnormality of the developing/immature brain . It is clinically categorized into four groups according to the predominant motor syndrome: extra-pyramidal or dys-kinetic, spastic quadriplegia and spastic diplegia. The purpose of this current study is to determine the effect of a selected task-oriented training on balance and functional mobility in children with cerebral palsy. This will be a randomized clinical trial, data will be collected from Elite Physio and Special children center from Faisalabad. Study will be conducted on 22 patients.
Inclusion criteria of this study is children who can walk with or without walking aids from age between 6 to 12 years old. Cerebral palsy children who has any musculoskeletal deformity in any of two limb, visual auditory, perceptual and auditory deficits, seizures or epilepsy , having botulinum toxin injections will be excluded.
Read more
Group A will be provided with task oriented exercise training on dynamic surface.
Group B will be provided with task oriented exercise training on static surface.Pre and post session balance and functional mobility will be assessed by Time up and Go scale and Functional Mobility scale.
Read the detailed description
Flow diagram for study data collection procedure (According to CONSORT guidelines) in case of an RCT.All the referred patient will be assessed for the eligibility criteria. Guardians of the patient will be asked to sign the consent .All the screened participents will be randomly allocated into two groups.( Group A TOET on dynamic surface) , (Group B TOET on static surface)
Group A: Dynamic surface group:
This group will be provided with task specific exercise training on dynamic surface in cerebral palsy. Following exercises will be performed in this group: Make the child bounce on swiss ball, reaching the toy with both hand kept over the head on platform swing, high sitting on swiss ball throwing ball with both hands, reaching the toy with one hand shifting the wait towards reaching side. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test.
Group B: Static surface group:
This group will be provided with task specific exercise training on static surface in cerebral palsy. The children in this group will receive following TOET: Sit to stand from various cjair heights , standing and reaching indifferent directions for an object, Stepping forwards, backwards, and sideways onto blocks of various heights, walking forward , backward and sideways, Walking up and down stairs. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test
- Conditions
- Cerebral Palsy
- Being tested
- task oriented exercise training on dynamic surface, task oriented exercise training on static surface
- Keywords
- task oriented exercise training, functional mobility, cerebral palsy, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task oriented exercise training on dynamic surfaceOther
Following exercises will be performed in this group: Make the child bounce on swiss ball, reaching the toy with both hand kept over the head on platform swing, high sitting on swiss ball throwing ball with both hands, reaching the toy with one hand shifting the wait towards reaching side.
task oriented exercise training on static surfaceOther
The children in this group will receive following TOET: Sit to stand from various cjair heights , standing and reaching indifferent directions for an object, Stepping forwards, backwards, and sideways onto blocks of various heights, walking forward , backward and sideways, Walking up and down stairs
| Study group | Role | What they receive |
|---|---|---|
| task oriented exercise training on dynamic surface | Experimental | This group will be provided with task specific exercise training on dynamic surface in cerebral palsy. Following exercises will be performed in this group: Make the child bounce on swiss ball, reaching the toy with both hand kept over the head on platform swing, high sitting on swiss ball throwing ball with both hands, reaching the toy with one hand shifting the wait towards reaching side. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test Receives: Other: task oriented exercise training on dynamic surface |
| task oriented training on static surface | Experimental | This group will be provided with task specific exercise training on static surface in cerebral palsy. The children in this group will receive following TOET: Sit to stand from various cjair heights , standing and reaching indifferent directions for an object, Stepping forwards, backwards, and sideways onto blocks of various heights, walking forward , backward and sideways, Walking up and down stairs. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test Receives: Other: task oriented exercise training on static surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Mobility scale
A child's functional mobility level in everyday life is defined by the FMS over a distance of 5 m, 50 m, and 500 m, which correspond to the home, school, and community settings, respectively. For each distance, an ordinal rating from 1 to 6 is assigned depending on the amount of assistance required for the child's mobility
Measured: 8 weeks
Time Up and Go Test:
Children with CP who are ambulatory will be evaluated for balance, anticipatory postural control, and functional mobility using the Timed Up and Go (TUG) test. It can distinguish between children with various CP subtypes and those at levels I-III of the Gross Motor.
Function Classification System (GMFCS) based on their performance. The TUG is a responsive and reliable test
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start12 Jun 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive task oriented exercise training on dynamic surface and group B will receive task oriented task training on static surface.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira latif, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460727
- Sponsor's protocol ID
- REC/RCR&AHS/23/0776
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Nov 4;101(44):e31565. doi: 10.1097/MD.0000000000031565.
PubMed 36343029Chaudhari S, BV RS. A study to compare the effect of task oriented training versus functional progressive resistance exercise strength training on gross motor functions in spastic diplegics. Int J Physical Educ Sports Health. 2020;7(5):24-302020.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task Oriented Exercice Training on Static Versus Dynamic Surface on Functional Mobility and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06460727
- Acronym / sponsor ID
- REC/RCR&AHS/23/0776
- Conditions
- Cerebral Palsy
- Keywords
- task oriented exercise training, functional mobility, cerebral palsy, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 14 Jun 2024 (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.
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement which are due to a non-progressive interference, lesion, or abnormality of the developing/immature brain . It is clinically categorized into four groups according to the predominant motor syndrome: extra-pyramidal or dys-kinetic, spastic quadriplegia and spastic diplegia. The purpose of this current study is to determine the effect of a selected task-oriented training on balance and functional mobility in children with cerebral palsy. This will be a randomized clinical trial, data will be collected from Elite Physio and Special children center from Faisalabad. Study will be conducted on 22 patients.
Inclusion criteria of this study is children who can walk with or without walking aids from age between 6 to 12 years old. Cerebral palsy children who has any musculoskeletal deformity in any of two limb, visual auditory, perceptual and auditory deficits, seizures or epilepsy , having botulinum toxin injections will be excluded.
Group A will be provided with task oriented exercise training on dynamic surface.
Group B will be provided with task oriented exercise training on static surface.Pre and post session balance and functional mobility will be assessed by Time up and Go scale and Functional Mobility scale.
Detailed description
Flow diagram for study data collection procedure (According to CONSORT guidelines) in case of an RCT.All the referred patient will be assessed for the eligibility criteria. Guardians of the patient will be asked to sign the consent .All the screened participents will be randomly allocated into two groups.( Group A TOET on dynamic surface) , (Group B TOET on static surface)
Group A: Dynamic surface group:
This group will be provided with task specific exercise training on dynamic surface in cerebral palsy. Following exercises will be performed in this group: Make the child bounce on swiss ball, reaching the toy with both hand kept over the head on platform swing, high sitting on swiss ball throwing ball with both hands, reaching the toy with one hand shifting the wait towards reaching side. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test.
Group B: Static surface group:
This group will be provided with task specific exercise training on static surface in cerebral palsy. The children in this group will receive following TOET: Sit to stand from various cjair heights , standing and reaching indifferent directions for an object, Stepping forwards, backwards, and sideways onto blocks of various heights, walking forward , backward and sideways, Walking up and down stairs. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive task oriented exercise training on dynamic surface and group B will receive task oriented task training on static surface.
| Arm | Type | Receives |
|---|---|---|
| task oriented exercise training on dynamic surface | Experimental | Other: task oriented exercise training on dynamic surfaceThis group will be provided with task specific exercise training on dynamic surface in cerebral palsy. Following exercises will be performed in this group: Make the child bounce on swiss ball, reaching the toy with both hand kept over the head on platform swing, high sitting on swiss ball throwing ball with both hands, reaching the toy with one hand shifting the wait towards reaching side. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test |
| task oriented training on static surface | Experimental | Other: task oriented exercise training on static surfaceThis group will be provided with task specific exercise training on static surface in cerebral palsy. The children in this group will receive following TOET: Sit to stand from various cjair heights , standing and reaching indifferent directions for an object, Stepping forwards, backwards, and sideways onto blocks of various heights, walking forward , backward and sideways, Walking up and down stairs. Exercise will be conducted 3 times per week for 8 weeks, pre and post session functional mobility will be measured by functional mobility scale and balance will be measured by Time up and Go test |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with cerebral palsy
- Age between 6 to 12 years
- Children with GMFCS level I and II
Key exclusion criteria (3 listed)
- CP children who has any musculoskeletal deformity in any of two limb
- Visual auditory, perceptual and auditory deficits, seizures or epilepsy
- Having botulinum toxin injections
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 |
|---|---|---|
| task oriented exercise training on dynamic surfaceFollowing exercises will be performed in this group: Make the child bounce on swiss ball, reaching the toy with both hand kept over the head on platform swing, high sitting on swiss ball throwing ball with both hands, reaching the toy with one hand shifting the wait towards reaching side. | Other | task oriented exercise training on dynamic surface |
| task oriented exercise training on static surfaceThe children in this group will receive following TOET: Sit to stand from various cjair heights , standing and reaching indifferent directions for an object, Stepping forwards, backwards, and sideways onto blocks of various heights, walking forward , backward and sideways, Walking up and down stairs | Other | task oriented training on static surface |
Primary outcome
Functional Mobility scale
Time frame: 8 weeks
A child's functional mobility level in everyday life is defined by the FMS over a distance of 5 m, 50 m, and 500 m, which correspond to the home, school, and community settings, respectively. For each distance, an ordinal rating from 1 to 6 is assigned depending on the amount of assistance required for the child's mobility
Time Up and Go Test:
Time frame: 8 Weeks
Children with CP who are ambulatory will be evaluated for balance, anticipatory postural control, and functional mobility using the Timed Up and Go (TUG) test. It can distinguish between children with various CP subtypes and those at levels I-III of the Gross Motor. Function Classification System (GMFCS) based on their performance. The TUG is a responsive and reliable test
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 29 Oct 2024.
- Background: PubMed 36343029Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Nov 4;101(44):e31565. doi: 10.1097/MD.0000000000031565.
- BackgroundChaudhari S, BV RS. A study to compare the effect of task oriented training versus functional progressive resistance exercise strength training on gross motor functions in spastic diplegics. Int J Physical Educ Sports Health. 2020;7(5):24-302020.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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.
Hira latif, MS 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 task oriented exercise training on dynamic surface and task oriented exercise training on static surface in people with Cerebral Palsy, 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 3 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: finished, as of the sponsor's last update on 29 Oct 2024. 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?
Functional Mobility scale (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06460727, which also lists 2 linked publications.
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 29 Oct 2024.