Combined Cognitive and Functional Strength Training in Children With cp

Not Applicable

Completed

• Conditions: Diplegic Cerebral Palsy
• Interventions: Other: functional strength training; Other: conventional physical therapy; Other: cognitive training

• Registration Number: NCT05348135
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-11
• Study First Submitted: 2022-03-12
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined treatment	cognitive training	-
Functional strength training	functional strength training	-
Cognitive training	cognitive training	-
Combined treatment	functional strength training	-
Conventional physical therapy	conventional physical therapy	-

Primary Outcome Measures

Name	Time	Method
change in attention / concentration measures	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	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	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	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	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 Outcome Measures

Name	Time	Method
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	A reliable and valid test used for assessing dynamic balance and functional mobility in the children.
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	measure the time spent for completing five sequential sit to stand to sit cycles. It is a reliable and valid measure of functional muscle strength and balance in CP children.

Trial Locations

Locations (1)

Faculty Of Physical Therapy; 🇪🇬 Cairo, Egypt