search
Back to results

Comparisons of Two Types of Armeo Robot for Upper Extremities

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Armeo power
Armeo spring
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 stroke, upper extremity rehabilitation robot, stroke rehabilitation

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
  • 26 ≤ Fugl-Meyer Assessment score ≤ 50
  • 3 ≤ Shoulder or elbow MRC scale ≤ 4
  • Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+
  • 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

Experimental

Arm Label

Armeo power

Armeo spring

Arm Description

Armeo power robot for upper extremity

Armeo spring robot for upper extremity

Outcomes

Primary Outcome Measures

Change of Wolf motor function test
Change of Wolf motor function test

Secondary Outcome Measures

Fugl-Meyer Assessment
Fugl-Meyer Assessment
Stroke impact scale
Stroke impact scale (Health-related quality of life measurements in stroke patients)
Motor activity log
Motor activity log
Mean velocity of upper extremity during reaching task
Curvature 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
% maximal voluntary contraction of upper extremity muscles during reaching task
surface EMG of upper extremity during reaching task
Behavioral activation system/behavioral inhibition system scale
Behavioral activation system subscale, behavioral inhibition system subscale
Beck depression index
Beck depression index
Intrinsic motivation inventory
Intrinsic motivation inventory
Stroke rehabilitation motivation scale
Stroke rehabilitation motivation scale

Full Information

First Posted
March 1, 2018
Last Updated
March 7, 2018
Sponsor
National Rehabilitation Center, Seoul, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT03465267
Brief Title
Comparisons of Two Types of Armeo Robot for Upper Extremities
Official Title
Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function
Detailed Description
The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist. Thus the results from this study might suggest usefulness of motorized robot.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor does not know the allocation of participants.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Armeo power
Arm Type
Experimental
Arm Description
Armeo power robot for upper extremity
Arm Title
Armeo spring
Arm Type
Experimental
Arm Description
Armeo spring robot for upper extremity
Intervention Type
Device
Intervention Name(s)
Armeo power
Intervention Description
Intervention with Armeo power rehabilitation robot for upper extremity (made by Hocoma), which provide assistive force. The intervention was done 4 weeks, 5 times/week, 30 minutes/day.
Intervention Type
Device
Intervention Name(s)
Armeo spring
Intervention Description
Intervention with Armeo spring rehabilitation robot for upper extremity (made by Hocoma), which is operated only by participants, without any assistive force from robot. The intervention was done 4 weeks, 5 times/week, 30 minutes/day.
Primary Outcome Measure Information:
Title
Change of Wolf motor function test
Description
Change of Wolf motor function test
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
Fugl-Meyer Assessment
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Stroke impact scale
Description
Stroke impact scale (Health-related quality of life measurements in stroke patients)
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Motor activity log
Description
Motor activity log
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
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
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
% maximal voluntary contraction of upper extremity muscles during reaching task
Description
surface EMG of upper extremity during reaching task
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Behavioral activation system/behavioral inhibition system scale
Description
Behavioral activation system subscale, behavioral inhibition system subscale
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Beck depression index
Description
Beck depression index
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Intrinsic motivation inventory
Description
Intrinsic motivation inventory
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Stroke rehabilitation motivation scale
Description
Stroke rehabilitation motivation scale
Time Frame
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 26 ≤ Fugl-Meyer Assessment score ≤ 50 3 ≤ Shoulder or elbow MRC scale ≤ 4 Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+ 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
Citations:
PubMed Identifier
33076952
Citation
Park JH, Park G, Kim HY, Lee JY, Ham Y, Hwang D, Kwon S, Shin JH. A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study. J Neuroeng Rehabil. 2020 Oct 19;17(1):137. doi: 10.1186/s12984-020-00763-6.
Results Reference
derived

Learn more about this trial

Comparisons of Two Types of Armeo Robot for Upper Extremities

We'll reach out to this number within 24 hrs