- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777773
Dual-task Training in Children With Cerebral Palsy
The Effect of Dual-task Training on Activity and Participation in Children With Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ordu, Turkey
- Ordu Uni
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: control group
classical physical therapy+ classical physical therapy
|
dual-task training
|
|
Other: study group
classical physical therapy+ dual-task training
|
dual-task training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10m walking test
Time Frame: 5 min
|
10m walking test (the speed of gait is measured)
|
5 min
|
|
10m walking test with dual-task
Time Frame: 5 min
|
10m walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
|
5 min
|
|
10m backward walking test
Time Frame: 5 min
|
10m backward walking test (the speed of gait is measured)
|
5 min
|
|
10m backward walking test with dual-task
Time Frame: 5 min
|
10m backward walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
|
5 min
|
|
balance
Time Frame: 15 min
|
Balance skills of participators are assessed with 'Pediatric Berg Balance' .
|
15 min
|
|
participation of daily life
Time Frame: 15 min
|
Participation of daily life of children are assessed with PODCI questionnaire.
|
15 min
|
|
Visual Gait Assessment
Time Frame: 10 min
|
Participators' positions of joints are assessed with Edinburg Visual Score.
Children walked 10m walking pathway.
The camera records were frontside, backward, and laterals.
|
10 min
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ordu347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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