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Dual Task Training in Spastic Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic exercises
Dual Task Training
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, dual task training, gait, balance

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KMSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physiotherapy Group

Dual Task Training Group

Arm Description

45 minutes, 2 days in a week for 8 weeks

45 minutes, 2 days in a week for 8 weeks

Outcomes

Primary Outcome Measures

Gate speed of time-distance gait parameters
Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
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.
Stride length of time-distance gait parameters
Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
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.
Stride time of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as sec.
Cadance of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.
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.
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.
Ellipse area of balance parameters
Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
February 4, 2020
Last Updated
March 21, 2021
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04263701
Brief Title
Dual Task Training in Spastic Cerebral Palsy
Official Title
Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, dual task training, gait, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Self-controlled study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physiotherapy Group
Arm Type
Active Comparator
Arm Description
45 minutes, 2 days in a week for 8 weeks
Arm Title
Dual Task Training Group
Arm Type
Experimental
Arm Description
45 minutes, 2 days in a week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Therapeutic exercises
Intervention Description
Conventional physiotherapy exercises for children with cerebral palsy
Intervention Type
Other
Intervention Name(s)
Dual Task Training
Intervention Description
Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy
Primary Outcome Measure Information:
Title
Gate speed of time-distance gait parameters
Description
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
Title
Step length of time-distance gait parameters
Description
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
Title
Stride length of time-distance gait parameters
Description
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
Title
Step time of time-distance gait parameters
Description
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
Title
Stride time of time-distance gait parameters
Description
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
Title
Cadance of time-distance gait parameters
Description
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
Title
Visual gait analysis
Description
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
Title
Center of Pressure path length of balance parameters
Description
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.
Title
Ellipse area of balance parameters
Description
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.
Title
Functional balance
Description
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
Secondary Outcome Measure Information:
Title
Gross Motor Function Measurement
Description
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
Title
Muscle Tonus
Description
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
Title
Functional Mobility Skills
Description
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
Title
Functional Independence Levels
Description
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
Title
Health-related quality of life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda Ozge Okur, Msc
Organizational Affiliation
KMSU
Official's Role
Principal Investigator
Facility Information:
Facility Name
KMSU
City
Kutahya
ZIP/Postal Code
43100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
35247824
Citation
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.
Results Reference
derived

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Dual Task Training in Spastic Cerebral Palsy

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