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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
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral palsy

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
June 20, 2017
Last Updated
June 27, 2017
Sponsor
Inje University
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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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