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Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hemiplegic, monoplegic, unilaterally affected or diplegic children aged 5-12 years with cerebral palsy Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions) or 2 (walks with restrictions) Understand simple commands Signing the consent form Exclusion Criteria: Children and their families who do not want to be involved in the study Children with vision and hearing problems hildren with secondary orthopedic problems and children with walking aids Circumstances that would prevent carrying out assessments and exercise training or communicating

Sites / Locations

  • Fethiye Special Son Atilim Special Education and Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Conventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.

Conventional rehabilitation program (stretching, strengthening, balance) will be employed.

Outcomes

Primary Outcome Measures

Pediatric Balance Scale (PBS)
The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.
Timed Up and Go Test (TUG)
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
One Leg Standing Test (OLST)
Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
3-Meter Backward Walk Test (3MBWT)
A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.
6 Meter Walk Test (6MWT)
A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command "Start". The stopwatch is stopped by touching the finish line.
The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)
The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2023
Last Updated
August 31, 2023
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05999617
Brief Title
Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy
Official Title
The Effectiveness of Dual Task Exercise Training on Balance, Mobility, Physical Performance and Quality of Life in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
August 21, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

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

5. Study Description

Brief Summary
Cerebral palsy (CP) is the most common neurological disorder in children and one of the major causes of motor disability. CP causes changes in postural and sensory integration, balance, coordination disorders and muscle weakness due to problems in muscle tone. An effective rehabilitation program is of great importance in solving many problems that can be associated with decreased balance control. Researchers have stated that rehabilitation programs with repetitive special tasks are effective. The aim of the study was to compare the effects of conventional physiotherapy and dual task exercise training in addition to conventional physiotherapy on balance, mobility, physical performance and quality of life in children with cerebral palsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Conventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation program (stretching, strengthening, balance) will be employed.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale (PBS)
Description
The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.
Time Frame
Change from Baseline PBS at 12 weeks
Title
Timed Up and Go Test (TUG)
Description
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
Time Frame
Change from Baseline TUG at 12 weeks
Title
One Leg Standing Test (OLST)
Description
Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
Time Frame
Change from Baseline OLST at 12 weeks
Title
3-Meter Backward Walk Test (3MBWT)
Description
A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.
Time Frame
Change from Baseline 3MBWT at 12 weeks
Title
6 Meter Walk Test (6MWT)
Description
A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command "Start". The stopwatch is stopped by touching the finish line.
Time Frame
Change from Baseline 6MWT at 12 weeks
Title
The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)
Description
The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.
Time Frame
Change from Baseline KINDL at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiplegic, monoplegic, unilaterally affected or diplegic children aged 5-12 years with cerebral palsy Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions) or 2 (walks with restrictions) Understand simple commands Signing the consent form Exclusion Criteria: Children and their families who do not want to be involved in the study Children with vision and hearing problems hildren with secondary orthopedic problems and children with walking aids Circumstances that would prevent carrying out assessments and exercise training or communicating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Uysal, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fethiye Special Son Atilim Special Education and Rehabilitation Center
City
Muğla
State/Province
Fethiye
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy

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