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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06460727
Other study ID # REC/RCR&AHS/23/0776
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 12, 2024
Est. completion date August 15, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Imran Amjad, PhD
Phone 9233224390125
Email Imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 . 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date August 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
task oriented exercise training on dynamic surface
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 surface
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

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 weeks
Primary 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
8 Weeks
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