Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
Primary Purpose
Stroke, Hemiplegia
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smart Glove Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Smart Glove Group
Homework group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment of Upper Extremity change
Evaluation tool for upper extremity function
Secondary Outcome Measures
Brunnström stage change
Evaluation tool for recovery
Modified Barthel Index change
Evaluation tool for the level of active daily living
Care Burden Scale change
Evaluation tool to measure the care burden
Hand power change
Hand power using hand-held dynamometer
Jebsen Hand function Test change
Evaluation tool for upper extremity function
Box and Block Test change
Evaluation tool for upper extremity function
Full Information
NCT ID
NCT02592759
First Posted
October 22, 2015
Last Updated
September 28, 2019
Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02592759
Brief Title
Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
Official Title
Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
The trial was prematurely terminated due to slow recruitment.
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smart Glove Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Homework group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Smart Glove Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity change
Description
Evaluation tool for upper extremity function
Time Frame
Change from baseline points at 2 weeks and 6 weeks
Secondary Outcome Measure Information:
Title
Brunnström stage change
Description
Evaluation tool for recovery
Time Frame
Change from baseline stage at 2 weeks and 6 weeks
Title
Modified Barthel Index change
Description
Evaluation tool for the level of active daily living
Time Frame
Change from baseline points at 2 weeks and 6 weeks
Title
Care Burden Scale change
Description
Evaluation tool to measure the care burden
Time Frame
Change from baseline points at 2 weeks and 6 weeks
Title
Hand power change
Description
Hand power using hand-held dynamometer
Time Frame
Change from baseline power at 2 weeks and 6 weeks
Title
Jebsen Hand function Test change
Description
Evaluation tool for upper extremity function
Time Frame
Change from baseline points at 2 weeks and 6 weeks
Title
Box and Block Test change
Description
Evaluation tool for upper extremity function
Time Frame
Change from baseline points at 2 weeks and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi-Uk Lee, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33240205
Citation
Kang MG, Yun SJ, Lee SY, Oh BM, Lee HH, Lee SU, Seo HG. Effects of Upper-Extremity Rehabilitation Using Smart Glove in Patients With Subacute Stroke: Results of a Prematurely Terminated Multicenter Randomized Controlled Trial. Front Neurol. 2020 Nov 9;11:580393. doi: 10.3389/fneur.2020.580393. eCollection 2020.
Results Reference
derived
Learn more about this trial
Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
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