NCT06460727

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

October 28, 2024

Conditions

Keywords

task oriented exercise trainingfunctional mobilitycerebral palsyBalance

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

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

Other: task oriented exercise training on static surface

Interventions

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 dynamic 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

task oriented training on static surface

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with cerebral palsy
  • Age between 6 to 12 years
  • Children with GMFCS level I and II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 36343029BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hira latif, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

June 12, 2024

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations