Combined Cognitive and Functional Strength Training in Children With cp

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

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

Study Overview

• Status: Completed
• Conditions: Diplegic Cerebral Palsy
• Intervention / Treatment: Other: functional strength training; Other: cognitive training; Other: conventional physical therapy

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Functional strength training	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.
ACTIVE_COMPARATOR: Cognitive training	Other: 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.
ACTIVE_COMPARATOR: Combined treatment	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.; Other: 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.
PLACEBO_COMPARATOR: Conventional physical therapy	Other: conventional physical therapy; including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ACTUAL): March 11, 2022

Study Registration Dates

• First Submitted: March 12, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: No:P.T.REC/012/003398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No