Comparison of Short- and Long-time Action Observation Tra... | NCT03201237

Studies
Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy

NCT03201237

Sponsor

Inje University

Status

Completed

Last Update Posted

Jun 28, 2017Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cerebral Palsy, Spastic

Interventions

Action observation training

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jun 15, 2017Actual

Completion Date

Jun 15, 2017Actual

First Submitted Date

Jun 20, 2017

First Submission Date that Met QC Criteria

Jun 27, 2017

First Posted Date

Jun 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2017

Last Update Posted Date

Jun 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
30 min AOT	Experimental		Other: Action observation training
60 min AOT	Placebo Comparator		Other: Action observation training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Action observation training	Other	Each child observed a task video and then performed a task	30 min AOT 60 min AOT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of grip strength	Power of hand grip	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Do H Kim, MS	Inje University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University		Gimhae	Gyeongsangnam-do	621-749	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided