NCT03201237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

14 days

First QC Date

June 20, 2017

Last Update Submit

June 27, 2017

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Change of grip strength

    Power of hand grip

    6 months

Study Arms (2)

30 min AOT

EXPERIMENTAL
Other: Action observation training

60 min AOT

PLACEBO COMPARATOR
Other: Action observation training

Interventions

Action observation trainingOTHER

Each child observed a task video and then performed a task

30 min AOT60 min AOT

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • severe spasticity in UL (MAS\>2)
  • orthopedic surgery in the UL within 6 months
  • absence of sensory

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University

Gimhae, Gyeongsangnam-do, 621-749, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Do H Kim, MS

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator for AOT

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 28, 2017

Study Start

June 1, 2017

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

KR(1)