Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients

Stroke Clinical Trial

Official title:

Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02592759
• Other study ID #: 16-2015-74
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment of Upper Extremity change	Evaluation tool for upper extremity function	Change from baseline points at 2 weeks and 6 weeks
Secondary	Brunnström stage change	Evaluation tool for recovery	Change from baseline stage at 2 weeks and 6 weeks
Secondary	Modified Barthel Index change	Evaluation tool for the level of active daily living	Change from baseline points at 2 weeks and 6 weeks
Secondary	Care Burden Scale change	Evaluation tool to measure the care burden	Change from baseline points at 2 weeks and 6 weeks
Secondary	Hand power change	Hand power using hand-held dynamometer	Change from baseline power at 2 weeks and 6 weeks
Secondary	Jebsen Hand function Test change	Evaluation tool for upper extremity function	Change from baseline points at 2 weeks and 6 weeks
Secondary	Box and Block Test change	Evaluation tool for upper extremity function	Change from baseline points at 2 weeks and 6 weeks