Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients

Not Applicable

Terminated

• Conditions: Stroke; Hemiplegia
• Interventions: Device: Smart Glove Treatment

• Registration Number: NCT02592759
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-28
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart Glove Group	Smart Glove Treatment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Box and Block Test change	Change from baseline points at 2 weeks and 6 weeks	Evaluation tool for upper extremity function
Jebsen Hand function Test change	Change from baseline points at 2 weeks and 6 weeks	Evaluation tool for upper extremity function
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of