Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation

Stroke Clinical Trial

Official title:

Distal Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation (tDCS) for Stroke Patients : a Double-blinded, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465631
• Other study ID #: NRC-2016-03-026
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2018
• Last updated: March 8, 2018
• Start date: August 9, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2018
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study to investigate the effect of combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. We hypothesized that experimental group (VR-based training with dual-tDCS) would improve distal upper extremity function rather than control group (VR-based training with dual sham tDCS).

Description:

This is a double-blind, randomized controlled study. Patients were randomly assigned to 1 : 1 ratio to experimental group (VR-based training with dual-tDCS; VR-Dual) or the control group (VR-based training with dual sham tDCS; VR-Sham) . For both conditions, VR-Dual and VR-Sham group commenced at the same time (20 minutes). The therapist and patients were blinded as to whether the patients received real or sham tDCS. The study was approved by the Ethics Committee of the National Rehabilitation Center, Korea, and all participants provided written informed consent before enrollment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• first-time ischemic or hemorrhagic stroke

• unilateral upper extremity functional deficits after stroke

• presence of a score of at least 3 points on the Medical Research Council (MRC)

• a score = 4 on the Brunnstrom stage

• a score = 25 on the Korean version of the Mini-Mental Status Exam (K-MMSE)

Exclusion Criteria:

• age < 20 years

• wrist and finger spasticity with the Modified Ashworth Scale (MAS) score = 2

• uncontrolled hypertension, heart problems, infection, or any history of seizure or epilepsy

• neurological disorders that cause motor deficits

• being unable to perform the task or to understand instructions

• presence of pacemaker, pregnancy, cognitive impairment, or psychiatric disorders

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• SMART Glove system with tDCS
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
• SMART Glove system with sham-tDCS
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and block test	Change of box and block test scores	baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
Secondary	Fugl-Meyer assessment of the upper extremity (FMA)	Change of FMA scores	baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
Secondary	Jebsen Taylor Hand Function Test (JTT)	Change of JTT scores	baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
Secondary	Grip strength	Change of Grip strength (JAMAR) scores	baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
Secondary	Stroke Impact Scale (SIS)	Change of SIS scores	pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)