Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Spastic
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Action observation training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral palsy
Eligibility Criteria
Inclusion Criteria:
- ages between 6 and 15 years
- confirmed diagnosis of spastic CP
- below grade 2 on the modified Ashworth scale
- between grade 4 and 8 on the house functional classification system
- ability to understand the assessor's instructions.
Exclusion Criteria:
- severe spasticity in UL (MAS>2)
- orthopedic surgery in the UL within 6 months
- absence of sensory
Sites / Locations
- Inje University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
30 min AOT
60 min AOT
Arm Description
Outcomes
Primary Outcome Measures
Change of grip strength
Power of hand grip
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03201237
Brief Title
Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy
Official Title
Main Researcher for Action Observation Training (AOT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje 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
To compared short- and long-time action observation training (AOT) in terms of grip strength, the Jebsen Taylor Hand Function Test (JTHF), the Quality of Upper Extremities Skills Test (QUEST), and the ABILHAND-Kids test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 min AOT
Arm Type
Experimental
Arm Title
60 min AOT
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Action observation training
Intervention Description
Each child observed a task video and then performed a task
Primary Outcome Measure Information:
Title
Change of grip strength
Description
Power of hand grip
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ages between 6 and 15 years
confirmed diagnosis of spastic CP
below grade 2 on the modified Ashworth scale
between grade 4 and 8 on the house functional classification system
ability to understand the assessor's instructions.
Exclusion Criteria:
severe spasticity in UL (MAS>2)
orthopedic surgery in the UL within 6 months
absence of sensory
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do H Kim, MS
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University
City
Gimhae
State/Province
Gyeongsangnam-do
ZIP/Postal Code
621-749
Country
Korea, Republic of
12. IPD Sharing Statement
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Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy
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