Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation Among Patients With Stroke

• Sponsor: National Rehabilitation Center, Seoul, Korea (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04055597
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Robot and tDCS on-line; Other: Robot and sham tDCS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke
• Actual Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot and tDCS on-line Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot	Other: Robot and tDCS on-line; Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Sham Comparator: Robot and sham tDCS Combined sham tDCS and upper extremity rehabilitation robot	Other: Robot and sham tDCS; Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Change of Scale for the assessment and rating of ataxia [Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline]

   Change of Scale for the assessment and rating of ataxia

2. Change of Functional ataxia rating scale - upper limb [Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline]

   Change of Functional ataxia rating scale - upper limb

Secondary Outcome Measures

1. Fugl-Meyer Assessment - upper extremity [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Fugl-Meyer Assessment - upper extremity

2. Composite cerebellar functional severity score [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Composite cerebellar functional severity score (Nine hole peg test + click test)

3. Jerk during reaching and finger pointing [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Kinematic data during reaching and finger pointing using Trakstar

4. Smoothness during reaching and finger pointing [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Kinematic data during reaching and finger pointing using Trakstar

5. Behavioral activation system/behavioral inhibition system scale [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   In terms of motivation

6. Beck's depression index [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Beck's depression index

7. Stroke rehabilitation motivation scale [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Stroke rehabilitation motivation scale

8. Intrinsic motivation inventory [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Intrinsic motivation inventory

9. Numeric rating scale for upper extremity pain [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

   Question about the upper extremity pain (0-10; higher is better)

10. Functional reaching test [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    Functional reaching test

11. modified Barthel index [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    modified Barthel index

12. % maximal voluntary contraction from upper extremity muscles during reaching task [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    data from surface electromyography from upper extremity muscles during reaching task

13. Kinematic data during scale for the assessment and rating of ataxia [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    Kinematic data during scale for the assessment and rating of ataxia

14. Scale for the assessment and rating of ataxia [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    Scale for the assessment and rating of ataxia

15. Functional ataxia rating scale - upper limb [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment

16. Kinematic data during scale during the Functional ataxia rating scale - upper limb [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]

    Kinematic data during scale during the Functional ataxia rating scale - upper limb

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stroke with cerebellar hemorrhage or infarction

• ataxia or tremor on upper extremities secondary to stroke

• Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

• History of surgery of affected upper limb

• Fracture of affected upper limb

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Rehabilitation Center	Seoul		Korea, Republic of	142884

Sponsors and Collaborators

• National Rehabilitation Center, Seoul, Korea

Investigators

• Principal Investigator: Joon-Ho Shin, MS, National Rehabilitation Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
• ClinicalTrials.gov Identifier: NCT04055597
• Other Study ID Numbers: NRC-2017-01-004
• First Posted: Aug 14, 2019
• Last Update Posted: Aug 14, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea: cerebellar stroke; upper extremity rehabilitation robot; transcranial direct current stimulation; stroke rehabilitation
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Aug 14, 2019