Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Other: Robot and sham tDCS; Other: Robot and tDCS on-line

• Registration Number: NCT04054102
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

Brief Summary

Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2019-06-18
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Hemiplegic patients secondary to first cerebrovascular accidents
• Onset ≤ 6 months
• Fugl-Meyer Assessment score ≥ 19
• Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria

• Severe upper extremity pain that could interfere with rehabilitation therapy
• Neurological disorders other than stroke that can cause motor deficits
• Uncontrolled severe medical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot and sham tDCS	Robot and sham tDCS	Combined sham tDCS and upper extremity rehabilitation robot
Robot and tDCS on-line	Robot and tDCS on-line	Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot

Primary Outcome Measures

Name	Time	Method
Change of kinematic data during scale for the assessment and rating of ataxia	Change from baseline at 4 weeks after baseline	kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)

Secondary Outcome Measures

Name	Time	Method
Action reach arm test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery
kinematic data during scale for the assessment	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
Fugl-Meyer Assessment - upper extremity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Wolf Motor Function Test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	an activity indicator, has 15 items for testing functional ability
Motor activity log	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of