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Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

3D exoskeleton type robot

2D end-effector type robot

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke

Eligibility Criteria

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

Inclusion Criteria:

Hemiplegic patients secondary to first cerebrovascular accidents
Onset ≥ 3 months
8 ≤ Fugl-Meyer Assessment score ≤ 30
Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
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 Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

3D exoskeleton type robot

2D end-effector type robot

Arm Description

3 dimension exoskeleton type upper extremity robot

2 dimension end-effector type upper extremity robot

Outcomes

Primary Outcome Measures

Change of Fugl-Meyer Assessment

Wolf motor function test

Secondary Outcome Measures

Wolf motor function test

Motor status score

medical research council scale of upper extremity

Modified Ashworth scale of upeer extremity

Pain of upper extremity

Pain complaints from participants

Stroke impact scale

Smoothness

Kinematics from Inmotion2 during point-to-point

Reach Error

Kinematics from Inmotion2 during point-to-point

Path Error

Kinematics from Inmotion2 during point-to-point

Mean velocity

Kinematics from Inmotion2 during point-to-point

Maximum velocity

Kinematics from Inmotion2 during point-to-point

Cricle size

Kinematics from Inmotion2 during circle drawing

Cricle independence

Kinematics from Inmotion2 during circle drawing

Intrinsic motivation inventory

stroke rehabilitation motivation scale

Beck depression index

Full Information

NCT ID

NCT03104881

First Posted

October 23, 2016

Last Updated

April 10, 2017

Sponsor

National Rehabilitation Center, Seoul, Korea

1. Study Identification

Unique Protocol Identification Number

NCT03104881

Brief Title

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Official Title

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Rehabilitation Center, Seoul, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3D exoskeleton type robot

Arm Type

Experimental

Arm Description

3 dimension exoskeleton type upper extremity robot

Arm Title

2D end-effector type robot

Arm Type

Experimental

Arm Description

2 dimension end-effector type upper extremity robot

Intervention Type

Device

Intervention Name(s)

3D exoskeleton type robot

Intervention Description

3 dimension exoskeleton type upper extremity robot

Intervention Type

Device

Intervention Name(s)

2D end-effector type robot

Intervention Description

2 dimension end-effector type upper extremity robot

Primary Outcome Measure Information:

Title

Change of Fugl-Meyer Assessment

Time Frame

Fugl-Meyer Assessment change from baseline at 4 weeks

Title

Wolf motor function test

Time Frame

Fugl-Meyer Assessment change from baseline at 4 weeks

Secondary Outcome Measure Information:

Title

Wolf motor function test

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Motor status score

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

medical research council scale of upper extremity

Time Frame

baseline

Title

Modified Ashworth scale of upeer extremity

Time Frame

baseline

Title

Pain of upper extremity

Description

Pain complaints from participants

Time Frame

from baseline to 4 weeks after baseline

Title

Stroke impact scale

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Smoothness

Description

Kinematics from Inmotion2 during point-to-point

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Reach Error

Description

Kinematics from Inmotion2 during point-to-point

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Path Error

Description

Kinematics from Inmotion2 during point-to-point

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Mean velocity

Description

Kinematics from Inmotion2 during point-to-point

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Maximum velocity

Description

Kinematics from Inmotion2 during point-to-point

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Cricle size

Description

Kinematics from Inmotion2 during circle drawing

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Cricle independence

Description

Kinematics from Inmotion2 during circle drawing

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Intrinsic motivation inventory

Time Frame

4 weeks after baseline

Title

stroke rehabilitation motivation scale

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Title

Beck depression index

Time Frame

baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Onset ≥ 3 months 8 ≤ Fugl-Meyer Assessment score ≤ 30 Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3 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

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

12. IPD Sharing Statement

Links:

URL

http://nrc.go.kr

Description

Site of the present study

Learn more about this trial

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

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