Back to resultsDual-task Training in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Diplegia, Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
dual-task training
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, dual-task training, activity, participation
Eligibility Criteria
Inclusion Criteria:
- Being diagnosed with cerebral palsy,
- Having spastic type unilateral and bilateral involvement,
- Being between the ages of 7-18,
- Being GMFCSS Level I and Level II,
- Continuing normal education (not being a mainstreaming student),
- Not having any surgical operation involving the musculoskeletal system in the last 6 months,
- Not having Botulinum Toxin application in the last 6 months.
Exclusion Criteria:
- Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
- Being a behavioral problem that makes it difficult to participate in the study,
- Inability to walk without support
Sites / Locations
- Ordu Uni
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
control group
study group
Arm Description
classical physical therapy+ classical physical therapy
classical physical therapy+ dual-task training
Outcomes
Primary Outcome Measures
10m walking test
10m walking test (the speed of gait is measured)
10m walking test with dual-task
10m walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
10m backward walking test
10m backward walking test (the speed of gait is measured)
10m backward walking test with dual-task
10m backward walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
balance
Balance skills of participators are assessed with 'Pediatric Berg Balance' .
participation of daily life
Participation of daily life of children are assessed with PODCI questionnaire.
Visual Gait Assessment
Participators' positions of joints are assessed with Edinburg Visual Score. Children walked 10m walking pathway. The camera records were frontside, backward, and laterals.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04777773
Brief Title
Dual-task Training in Children With Cerebral Palsy
Official Title
The Effect of Dual-task Training on Activity and Participation in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sema BÜĞÜŞAN ORUÇ
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
There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. In all these studies, it is clearly seen that children with CP have more dual-task complexities than their typically developing peers. Some of these studies draw attention to dual-task education in children with CP. However, other than a randomized controlled study and a case report in the literature, we did not find any studies investigating the effectiveness of dual-task training in children with CP. When the literature is examined in detail, there is no study that examines the effect of dual-task exercise programs on walking activities and children's participation in daily life in children with CP.
This study has been planned based on this deficiency in the literature. Based on ICF, This study has been planned dual-task training for children with CP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Diplegia, Hemiplegic Cerebral Palsy, Physical Disability, Participation, Patient, Activity, Motor
Keywords
cerebral palsy, dual-task training, activity, participation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Other
Arm Description
classical physical therapy+ classical physical therapy
Arm Title
study group
Arm Type
Other
Arm Description
classical physical therapy+ dual-task training
Intervention Type
Other
Intervention Name(s)
dual-task training
Intervention Description
dual-task training
Primary Outcome Measure Information:
Title
10m walking test
Description
10m walking test (the speed of gait is measured)
Time Frame
5 min
Title
10m walking test with dual-task
Description
10m walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
Time Frame
5 min
Title
10m backward walking test
Description
10m backward walking test (the speed of gait is measured)
Time Frame
5 min
Title
10m backward walking test with dual-task
Description
10m backward walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
Time Frame
5 min
Title
balance
Description
Balance skills of participators are assessed with 'Pediatric Berg Balance' .
Time Frame
15 min
Title
participation of daily life
Description
Participation of daily life of children are assessed with PODCI questionnaire.
Time Frame
15 min
Title
Visual Gait Assessment
Description
Participators' positions of joints are assessed with Edinburg Visual Score. Children walked 10m walking pathway. The camera records were frontside, backward, and laterals.
Time Frame
10 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being diagnosed with cerebral palsy,
Having spastic type unilateral and bilateral involvement,
Being between the ages of 7-18,
Being GMFCSS Level I and Level II,
Continuing normal education (not being a mainstreaming student),
Not having any surgical operation involving the musculoskeletal system in the last 6 months,
Not having Botulinum Toxin application in the last 6 months.
Exclusion Criteria:
Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
Being a behavioral problem that makes it difficult to participate in the study,
Inability to walk without support
Facility Information:
Facility Name
Ordu Uni
City
Ordu
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dual-task Training in Children With Cerebral Palsy
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