NCT02772510

Brief Summary

The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Feb 2015

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

Study Start

First participant enrolled

February 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

May 8, 2016

Last Update Submit

October 23, 2016

Conditions

Stroke

Keywords

StrokeRehabilitationHandGameFunctional electrical stimulationVirtual reality

Outcome Measures

Primary Outcomes (2)

  • Wolf Motor Function Test

    4 weeks from baseline

  • Fugl-Meyer Assessment-hand & wrist

    4 weeks from baseline

Secondary Outcomes (16)

  • Wolf Motor Function Test

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Box and Block Test

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Fugl-Meyer Assessment upper extremity

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Stroke Impact Scale

    baseline, 4 weeks after baseline

  • Motor Activity Log

    baseline, 4 weeks after baseline

  • +11 more secondary outcomes

Study Arms (2)

Smart glove system with functional electrical stimulation

EXPERIMENTAL

game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity

Device: Smart glove system with functional electrical stimulation

Functional electrical stimulation

ACTIVE COMPARATOR

functional electrical stimulation on upper extremity

Device: Functional electrical stimulation

Interventions

Smart glove system with functional electrical stimulationDEVICE

Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity

Smart glove system with functional electrical stimulation
Functional electrical stimulationDEVICE

Functional electrical stimulation on distal upper extremity

Functional electrical stimulation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first-ever ischemic or hemorrhagic stroke
  • wrist extensor of medical research council scale 1\~3
  • No clinical evidence of limited passive range of motion of affected wrist

You may not qualify if:

  • age \<18 years
  • severe aphasia resulting in communication difficulties confounding intervention and outcome measures
  • severe cognitive impairment resulting cooperation difficulties
  • spasticity \> modified Ashworth scale 1+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, Seoul, 142884, South Korea

RECRUITING

Related Publications (1)

  • Lee SH, Lee JY, Kim MY, Jeon YJ, Kim S, Shin JH. Virtual Reality Rehabilitation With Functional Electrical Stimulation Improves Upper Extremity Function in Patients With Chronic Stroke: A Pilot Randomized Controlled Study. Arch Phys Med Rehabil. 2018 Aug;99(8):1447-1453.e1. doi: 10.1016/j.apmr.2018.01.030. Epub 2018 Mar 2.

    PMID: 29505744DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin, MS

CONTACT

82-2-901-1884asfreelyas@gmail.com

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

May 8, 2016

First Posted

May 13, 2016

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)