NCT02029651

Brief Summary

The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

January 1, 2014

Last Update Submit

April 13, 2015

Conditions

Keywords

StrokeHandRehabilitationGame

Outcome Measures

Primary Outcomes (1)

  • Fugl-meyer assessment_upper extremity

    Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention

Secondary Outcomes (7)

  • Fugl-meyer assessment_upper extremity

    Baseline, after 10th intervention, after 20th intervention, 1 month after intervention

  • Jebsen hand function test

    Baseline, after 10th intervention, after 20th intervention, 1 month after intervention

  • Purdue pegboard

    Baseline, after 10th intervention, after 20th intervention, 1 month after intervention

  • Stroke impact scale

    Baseline, after 20th intervention

  • Modified Ashworth scale of affected upper extremity

    Baseline, after 20th intervention

  • +2 more secondary outcomes

Study Arms (2)

E-glove system

EXPERIMENTAL

E-glove rehabilitation system for upper extremity

Device: E-glove system

Conventional occupational therapy

ACTIVE COMPARATOR

conventional occupational therapy

Procedure: Conventional occupational therapy

Interventions

Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke

E-glove system

conventional occupational therapy

Conventional occupational therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemiplegic stroke patients
  • Medical research council scale \>= 2 of finger or wrist flexor/extensor
  • Medical research council scale \>= 2 of elbow pronation/supination

You may not qualify if:

  • Bilateral weakness of upper extremities
  • Uncontrolled medical or surgical illness
  • Predisposing psychological or neurological disorders
  • Severe aphasia unable to communicate
  • Severe cognitive impairment not to cooperate
  • Severe pain impeding upper extremity rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, Seoul, 142884, South Korea

Location

Related Publications (1)

  • Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joon-Ho Shin

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager

Study Record Dates

First Submitted

January 1, 2014

First Posted

January 8, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations