An interventional study of Therapeutic exercises and Dual Task Training in Cerebral Palsy, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment
This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.
In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27 and above from the Modified Mini Mental Test were included.
Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8 weeks, and in addition to the routine physiotherapy program dual task training program 45 minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the routine physiotherapy program and after the dual task training program. Children will be evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform, Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.
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This study's enrollment of 10 is below the median of 30 across 537 interventional studies indexed under Paralysis.
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Exclusion Criteria:
45 minutes, 2 days in a week for 8 weeks
Other: Therapeutic exercises
45 minutes, 2 days in a week for 8 weeks
Other: Dual Task Training
Conventional physiotherapy exercises for children with cerebral palsy
Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy
Gate speed of time-distance gait parameters
Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Step length of time-distance gait parameters
Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Stride length of time-distance gait parameters
Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Step time of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Stride time of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as sec.
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Cadance of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Visual gait analysis
Visual gait analysis will be performed with Edinburgh Visual Gait Score. Edinburg Visual Gait Score is scoring between 0 to 34 for each lower extremity. The higher scores points above 0 means abnormal gate.
Time frame: Change from baseline visual gait analysis at 8th week and 16th week
Center of Pressure path length of balance parameters
Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.
Time frame: Change from baseline balance parameters at 8th week and 16th week.
Ellipse area of balance parameters
Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.
Time frame: Change from baseline balance parameters at 8th week and 16th week.
Functional balance
Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance.
Time frame: Change from baseline functional balance at 8th week and 16th week
Gross Motor Function Measurement
Gross motor function measurement will be evaluate using with Gross Motor Function Measurement-88. The instrument consist of 5 dimensions which names are A- Lying and rolling, B- Sitting, C- Crawling and Kneeling, D- Standing and E- Walking-running-jumping. Each dimension is scoring 0-100. The higher scores indicate better motor function.
Time frame: Change from baseline Gross Motor Function Measurement at 8th week and 16th week
Muscle Tonus
Muscle tonus will be evaluate using with Modified Ashworth Scale. This assesment will be performed by a physiotherapist. The Physiotherapist evaluate the muscle tonus of upper and lower extremity muscules. Scoring is between 0-4 and higher scores indicate hypertonus.
Time frame: Change from baseline Muscle Tonus at 8th week and 16th week
Functional Mobility Skills
Functional mobility skills will be evaluate using with 1-Minute Walk Test. The test perform on a 20 meters platform. The patient walk on the platform as quick as in 1 munite. The walking distance is recorded.
Time frame: Change from baseline Functional Mobility Skills at 8th week and 16th week
Functional Independence Levels
Functional independence levels will be evaluate using with Functional Independence Measurement (WeeFIM). WeeFIM is consist of 6 part, 18 items. It consists of self-care, sphincter control, locomotion, transfers, communication and social cognition subtitles. Scoring is between 18 to 126 and the higher scores indicate better functional indepence levels.
Time frame: Change from baseline Functional Independence Levels at 8th week and 16th week
Health-related quality of life
Health-related quality of life will be evaluate using with Pediatric Quality of Life Inventory TM. The inventory include daily activities, school activities, movement and balance, pain and hurt, fatique, eating activities and speech and communication subtitles. Each subtitles is scoring 0 to 100 and the higher scores indicate lower problems.
Time frame: Change from baseline health-related quality of life at 8th week and 16th week
Plan to share: No — This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Kutahya Health Sciences University