Dual Task Training in Spastic Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Therapeutic exercises; Other: Dual Task Training

• Registration Number: NCT04263701
• Lead Sponsor: Kutahya Health Sciences University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-21
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Having been diagnosed with spastic diplegic cerebral palsy,
• Being at level 1 or 2 according to the Gross Motor Function Classification System,
• Being at level 1 according to Communication Function Classification System,
• To adapt to the evaluations,
• To get 27 points or above from the Modified Mini Mental Test (MMMT).

Exclusion Criteria

• Having had injuries such as strains, sprains or fractures of the lower extremity in the last six months,
• Having undergone a surgical intervention or Botulinum toxin in the last six months,
• Having any known chronic systemic problems,
• Having uncontrollable seizures,
• Having vision or hearing problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Physiotherapy Group	Therapeutic exercises	45 minutes, 2 days in a week for 8 weeks
Dual Task Training Group	Dual Task Training	45 minutes, 2 days in a week for 8 weeks

Primary Outcome Measures

Name	Time	Method
Gate speed of time-distance gait parameters	Change from baseline time-distance gait parameters at 8th week and 16th week	Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
Visual gait analysis	Change from baseline visual gait analysis at 8th week and 16th week	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.
Stride length of time-distance gait parameters	Change from baseline time-distance gait parameters at 8th week and 16th week	Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
Functional balance	Change from baseline functional balance at 8th week and 16th week	Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance.
Step time of time-distance gait parameters	Change from baseline time-distance gait parameters at 8th week and 16th week	Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.
Cadance of time-distance gait parameters	Change from baseline time-distance gait parameters at 8th week and 16th week	Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.
Center of Pressure path length of balance parameters	Change from baseline balance parameters at 8th week and 16th week.	Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.
Step length of time-distance gait parameters	Change from baseline time-distance gait parameters at 8th week and 16th week	Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.
Stride time of time-distance gait parameters	Change from baseline time-distance gait parameters at 8th week and 16th week	Step time will be evaluated using with gait platform.The software gives the outcome as sec.
Ellipse area of balance parameters	Change from baseline balance parameters at 8th week and 16th week.	Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.

Secondary Outcome Measures

Name	Time	Method
Functional Mobility Skills	Change from baseline Functional Mobility Skills at 8th week and 16th week	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.
Gross Motor Function Measurement	Change from baseline Gross Motor Function Measurement at 8th week and 16th week	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.
Muscle Tonus	Change from baseline Muscle Tonus at 8th week and 16th week	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.
Health-related quality of life	Change from baseline health-related quality of life at 8th week and 16th week	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.
Functional Independence Levels	Change from baseline Functional Independence Levels at 8th week and 16th week	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.

Trial Locations

Locations (1)

KMSU; 🇹🇷 Kutahya, Turkey