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Clinical Trials/NCT05348135
NCT05348135
Completed
Not Applicable

Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy

Cairo University1 site in 1 country64 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diplegic Cerebral Palsy
Sponsor
Cairo University
Enrollment
64
Locations
1
Primary Endpoint
change in attention / concentration measures
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.

Detailed Description

This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
March 11, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaa Fahmy Hassan Al Nemr

principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • chronological age ranged from 8 to 12 years,
  • spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS
  • can follow instructions given to them,
  • their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II \& III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E\&R).

Exclusion Criteria

  • children who had visual or auditory problems
  • children who took any medicine affecting alertness
  • fixed deformities in the joints of upper \& lower limbs
  • any orthopedic surgery in lower limbs within 6 months before study
  • epileptic children.

Outcomes

Primary Outcomes

change in attention / concentration measures

Time Frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

* Computer based RehaCom software used to assess attention / concentration cognitive domain of function. It is clinically proven and evidence-based software. * minimum reaction time ( in seconds) of attention / concentration program was assessed

change in GMFM-88 measures

Time Frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

criterion-referenced scale that measure gross motor function in children with CP.

change in figural memory measures

Time Frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

* Computer based RehaCom software used to assess figural memory cognitive domain of function.It is clinically proven and evidence-based software. * minimum reaction time ( in seconds) of figural memory program was assessed

change in reaction behavior measures

Time Frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

Computer based RehaCom software used to assess reaction behavior cognitive domain of function. It is clinically proven and evidence-based software. - minimum reaction time ( in seconds) of reaction behavior program was assessed

change in logical reasoning measures

Time Frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

Computer based RehaCom software used to assess logical reasoning cognitive domain of function. It is clinically proven and evidence-based software. - minimum reaction time ( in seconds) of logical reasoning program was assessed

Secondary Outcomes

  • change in Timed up and go test (TUG)measure(The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up)
  • change in Five times sit to stand test (FTSST) measure(The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up)

Study Sites (1)

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