NCT02592759

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

October 22, 2015

Last Update Submit

September 28, 2019

Conditions

StrokeHemiplegia

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment of Upper Extremity change

    Evaluation tool for upper extremity function

    Change from baseline points at 2 weeks and 6 weeks

Secondary Outcomes (6)

  • Brunnström stage change

    Change from baseline stage at 2 weeks and 6 weeks

  • Modified Barthel Index change

    Change from baseline points at 2 weeks and 6 weeks

  • Care Burden Scale change

    Change from baseline points at 2 weeks and 6 weeks

  • Hand power change

    Change from baseline power at 2 weeks and 6 weeks

  • Jebsen Hand function Test change

    Change from baseline points at 2 weeks and 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Smart Glove Group

EXPERIMENTAL

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

Homework group

NO INTERVENTION

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.

Interventions

Smart Glove TreatmentDEVICE

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.

Smart Glove Group

Eligibility Criteria

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

You may qualify if:

  • CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33240205DERIVED

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shi-Uk Lee, MD, PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

KR(1)