Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients

September 28, 2019 updated by: Shi-Uk Lee, Seoul National University Hospital

Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke

The purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
  • 72 hours ~ 3 months after stroke
  • Upper extremity hemiplegia with Brunnström stage 2-5.
  • The patients can sit to receive treatment for at least 1 hour

Exclusion Criteria:

  • The patients cannot perform occupational treatments because of severe hemineglect or hemianopia
  • Contracture due to severe limitation of motion
  • Upper extremity spasticity in the wrist and fingers with modified Ashworth scale > 2 points
  • Fugl-Meyer Assessment-Wrist & Hand score >= 21 points
  • moderate to severe cognitive dysfunction < MMSE 18 points
  • Severe aphasia
  • The patients who has been diagnosed as malignant tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smart Glove Group
The subjects will be treated with conventional occupational therapy for 30 minutes and smart glove treatment for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks.
Device: Smart Glove Treatment
Smart glove is digital motion-based treatment device for stroke rehabilitation. The stroke patients wear this glove and hand motion is displayed on the computer monitor. They play games with this glove and are motivated to rehabilitation treatment because of fun.
No Intervention: Homework group
The subjects will be treated with conventional occupational therapy for 30 minutes and upper extremity rehabilitation homework which means the self training at bedside, for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of Upper Extremity change
Time Frame: Change from baseline points at 2 weeks and 6 weeks
Evaluation tool for upper extremity function
Change from baseline points at 2 weeks and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brunnström stage change
Time Frame: Change from baseline stage at 2 weeks and 6 weeks
Evaluation tool for recovery
Change from baseline stage at 2 weeks and 6 weeks
Modified Barthel Index change
Time Frame: Change from baseline points at 2 weeks and 6 weeks
Evaluation tool for the level of active daily living
Change from baseline points at 2 weeks and 6 weeks
Care Burden Scale change
Time Frame: Change from baseline points at 2 weeks and 6 weeks
Evaluation tool to measure the care burden
Change from baseline points at 2 weeks and 6 weeks
Hand power change
Time Frame: Change from baseline power at 2 weeks and 6 weeks
Hand power using hand-held dynamometer
Change from baseline power at 2 weeks and 6 weeks
Jebsen Hand function Test change
Time Frame: Change from baseline points at 2 weeks and 6 weeks
Evaluation tool for upper extremity function
Change from baseline points at 2 weeks and 6 weeks
Box and Block Test change
Time Frame: Change from baseline points at 2 weeks and 6 weeks
Evaluation tool for upper extremity function
Change from baseline points at 2 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Shi-Uk Lee, MD, PhD, SMG-SNU Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 28, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-2015-74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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