- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460727
Task Oriented Training on Static Versus Dynamic Surface on Balance in CP
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with cerebral palsy
- Age between 6 to 12 years
- Children with GMFCS level I and II
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: task oriented exercise training on dynamic surface
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
|
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.
|
|
Experimental: task oriented training on static surface
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
8 weeks
|
|
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 |
8 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hira latif, MS, Riphah International University
Publications and helpful links
General 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.
- Chaudhari 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0776
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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