Back to resultsCombined Cognitive and Functional Strength Training in Children With cp
Primary Purpose
Diplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
functional strength training
cognitive training
conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diplegic Cerebral Palsy
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.
Sites / Locations
- Faculty Of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Functional strength training
Cognitive training
Combined treatment
Conventional physical therapy
Arm Description
Outcomes
Primary Outcome Measures
change in GMFM-88 measures
criterion-referenced scale that measure gross motor function in children with CP.
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
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
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
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05348135
Brief Title
Combined Cognitive and Functional Strength Training in Children With cp
Official Title
Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional strength training
Arm Type
Active Comparator
Arm Title
Cognitive training
Arm Type
Active Comparator
Arm Title
Combined treatment
Arm Type
Active Comparator
Arm Title
Conventional physical therapy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
functional strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
cognitive training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training
Primary Outcome Measure Information:
Title
change in GMFM-88 measures
Description
criterion-referenced scale that measure gross motor function in children with CP.
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Title
change in attention / concentration measures
Description
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
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Title
change in figural memory measures
Description
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
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Title
change in reaction behavior measures
Description
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
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Title
change in logical reasoning measures
Description
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
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Secondary Outcome Measure Information:
Title
change in Five times sit to stand test (FTSST) measure
Description
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.
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Title
change in Timed up and go test (TUG)measure
Description
A reliable and valid test used for assessing dynamic balance and functional mobility in the children.
Time Frame
The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty Of Physical Therapy
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Combined Cognitive and Functional Strength Training in Children With cp
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