Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients

NCT ID: NCT02772510

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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Stroke Rehabilitation Hand Game Functional electrical stimulation Virtual reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Smart glove system with functional electrical stimulation

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

Group Type EXPERIMENTAL

Smart glove system with functional electrical stimulation

Intervention Type DEVICE

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

Functional electrical stimulation

functional electrical stimulation on upper extremity

Group Type ACTIVE_COMPARATOR

Functional electrical stimulation

Intervention Type DEVICE

Functional electrical stimulation on distal upper extremity

Interventions

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Smart glove system with functional electrical stimulation

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

Intervention Type DEVICE

Functional electrical stimulation

Functional electrical stimulation on distal upper extremity

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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+
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Joon-Ho Shin

Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon-Ho Shin, MS

Role: PRINCIPAL_INVESTIGATOR

National Rehabilitation Center

Locations

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National Rehabilitation Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joon-Ho Shin, MS

Role: CONTACT

Phone: 82-2-901-1884

Email: [email protected]

Facility Contacts

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Joon-Ho Shin, MS

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29505744 (View on PubMed)

Other Identifiers

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NRC-2015-01-004

Identifier Type: -

Identifier Source: org_study_id