Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients

Sponsor

Seoul National University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02592759

Collaborator

SMG-SNU Boramae Medical Center (Other)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiplegia	Device: Smart Glove Treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Assessment of Upper Extremity change [Change from baseline points at 2 weeks and 6 weeks]
Evaluation tool for upper extremity function

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital
SMG-SNU Boramae Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shi-Uk Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02592759

Other Study ID Numbers:

16-2015-74

First Posted:

Oct 30, 2015

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Additional relevant MeSH terms:

Stroke

Hemiplegia

Study Results

No Results Posted as of Oct 1, 2019