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The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
distal upper rehabilitation robot
proximal upper rehabilitation robot
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring upper limb rehabilitation, stroke, proximal upper rehabilitation robot, distal upper rehabilitation robot

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Onset ≥ 3 months
  • 29 ≤ Fugl-Meyer Assessment score
  • 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

Sites / Locations

  • National Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

distal upper rehabilitation robot

proximal upper rehabilitation robot

Arm Description

experimental group that applied the distal upper rehabilitation robot

control group that applied the proximal upper rehabilitation robot

Outcomes

Primary Outcome Measures

Wolf motor function test
an activity indicator, has 15 items for testing functional ability
Fugl-Meyer Assessment
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment

Secondary Outcome Measures

Fugl-Meyer Assessment
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Motor activity log
Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.
Action reach arm test
to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Motor status score
evaluate the impairment level
Box and block test
measures unilateral gross manual dexterity
Wolf motor function test
an activity indicator, has 15 items for testing functional ability
Mean velocity of upper extremity during reaching task
Mean velocity of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Curvature of upper extremity during reaching task
Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Jerk of upper extremity during reaching task
Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Motor evoked potential over motor cortex of the affected side
Motor evoked potential elicited by noninvasive stimulation (rTMS) of the motor cortex
Stroke impact scale 3.0
Total score and individual domain score of stroke impact scale

Full Information

First Posted
August 12, 2019
Last Updated
September 8, 2021
Sponsor
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04054700
Brief Title
The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients
Official Title
The Effect of Upper Limb Rehabilitation on the Application of Proximal Upper Rehabilitation Robot and Distal Upper Rehabilitation Robot With Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with stroke patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb rehabilitation, stroke, proximal upper rehabilitation robot, distal upper rehabilitation robot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
distal upper rehabilitation robot
Arm Type
Experimental
Arm Description
experimental group that applied the distal upper rehabilitation robot
Arm Title
proximal upper rehabilitation robot
Arm Type
Other
Arm Description
control group that applied the proximal upper rehabilitation robot
Intervention Type
Device
Intervention Name(s)
distal upper rehabilitation robot
Intervention Description
Intervention with distal upper rehabilitation robot
Intervention Type
Device
Intervention Name(s)
proximal upper rehabilitation robot
Intervention Description
Intervention with proximal upper rehabilitation robot
Primary Outcome Measure Information:
Title
Wolf motor function test
Description
an activity indicator, has 15 items for testing functional ability
Time Frame
change from baseline at 4 weeks
Title
Fugl-Meyer Assessment
Description
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Motor activity log
Description
Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Action reach arm test
Description
to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Motor status score
Description
evaluate the impairment level
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Box and block test
Description
measures unilateral gross manual dexterity
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Wolf motor function test
Description
an activity indicator, has 15 items for testing functional ability
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Mean velocity of upper extremity during reaching task
Description
Mean velocity of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Curvature of upper extremity during reaching task
Description
Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Jerk of upper extremity during reaching task
Description
Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Motor evoked potential over motor cortex of the affected side
Description
Motor evoked potential elicited by noninvasive stimulation (rTMS) of the motor cortex
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Stroke impact scale 3.0
Description
Total score and individual domain score of stroke impact scale
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Onset ≥ 3 months 29 ≤ Fugl-Meyer Assessment score 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon-Ho Shin, MS
Phone
82-2-901-1884
Email
asfreelyas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients

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