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Clinical Trials/NCT04263701
NCT04263701
Completed
Not Applicable

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

Kutahya Health Sciences University1 site in 1 country10 target enrollmentJuly 1, 2019
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Kutahya Health Sciences University
Enrollment
10
Locations
1
Primary Endpoint
Gate speed of time-distance gait parameters
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
March 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kutahya Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Eda Ozge OKUR

Principal Investigator

Kutahya Health Sciences University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Gate speed of time-distance gait parameters

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Functional Mobility Skills(Change from baseline Functional Mobility Skills at 8th week and 16th week)
  • Gross Motor Function Measurement(Change from baseline Gross Motor Function Measurement at 8th week and 16th week)
  • Muscle Tonus(Change from baseline Muscle Tonus at 8th week and 16th week)
  • Health-related quality of life(Change from baseline health-related quality of life at 8th week and 16th week)
  • Functional Independence Levels(Change from baseline Functional Independence Levels at 8th week and 16th week)

Study Sites (1)

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