Dual Task Training in Spastic Cerebral Palsy

Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Therapeutic exercises; Other: Dual Task Training

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kutahya, Turkey, 43100
    • KMSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Physiotherapy Group; 45 minutes, 2 days in a week for 8 weeks	Other: Therapeutic exercises; Conventional physiotherapy exercises for children with cerebral palsy
EXPERIMENTAL: Dual Task Training Group; 45 minutes, 2 days in a week for 8 weeks	Other: Dual Task Training; Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gate speed of time-distance gait parameters	Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Change from baseline functional balance at 8th week and 16th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Change from baseline health-related quality of life at 8th week and 16th week

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Eda Ozge Okur, Msc, KMSU

Publications and helpful links

General Publications

• Okur EO, Arik MI, Okur I, Gokpinar HH, Gunel MK. Dual-task training effect on gait parameters in children with spastic diplegic cerebral palsy: Preliminary results of a self-controlled study. Gait Posture. 2022 May;94:45-50. doi: 10.1016/j.gaitpost.2022.02.020. Epub 2022 Feb 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (ACTUAL): February 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: gait; cerebral palsy; balance; dual task training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: KMSU

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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