Comparisons of Two Types of Armeo Robot for Upper Extremities

March 7, 2018 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial

Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 142884
        • Recruiting
        • National Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Armeo power
Armeo power robot for upper extremity
Device: Armeo power

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.
Experimental: Armeo spring
Armeo spring robot for upper extremity
Device: Armeo spring

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Wolf motor function test
Time Frame: change from baseline at 4 weeks
Change of Wolf motor function test
change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale (Health-related quality of life measurements in stroke patients)
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor activity log
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor activity log
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Mean velocity of upper extremity during reaching task
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Curvature of the magnetic sensor trajectory (Kinematics of upper extremity)during reaching task
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Curvature of upper extremity during reaching task
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk of upper extremity during reaching task
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% maximal voluntary contraction of upper extremity muscles during reaching task
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
surface EMG of upper extremity during reaching task
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system/behavioral inhibition system scale
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system subscale, behavioral inhibition system subscale
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression index
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression index
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
baseline, 4 weeks after baseline, 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Rehabilitation Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2017-01-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Armeo power

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe