Combined Cognitive and Functional Strength Training in Children With cp

Diplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348135
• Other study ID #: No:P.T.REC/012/003398
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 11, 2022

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 11, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy

Intervention

Other:
• functional strength training
children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.
• cognitive training
Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.
• conventional physical therapy
including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training

Locations

Country	Name	City	State
Egypt	Faculty Of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in GMFM-88 measures	criterion-referenced scale that measure gross motor function in children with CP.	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Primary	change in attention / concentration measures	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	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Primary	change in figural memory measures	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	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Primary	change in reaction behavior measures	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	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Primary	change in logical reasoning measures	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	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Secondary	change in Five times sit to stand test (FTSST) measure	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.	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Secondary	change in Timed up and go test (TUG)measure	A reliable and valid test used for assessing dynamic balance and functional mobility in the children.	The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up