Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

April 10, 2017 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

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

18 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
  • 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

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: 3D exoskeleton type robot
3 dimension exoskeleton type upper extremity robot
Device: 3D exoskeleton type robot
3 dimension exoskeleton type upper extremity robot
Experimental: 2D end-effector type robot
2 dimension end-effector type upper extremity robot
Device: 2D end-effector type robot
2 dimension end-effector type upper extremity robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Fugl-Meyer Assessment
Time Frame: Fugl-Meyer Assessment change from baseline at 4 weeks
Fugl-Meyer Assessment change from baseline at 4 weeks
Wolf motor function test
Time Frame: Fugl-Meyer Assessment change from baseline at 4 weeks
Fugl-Meyer Assessment change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wolf motor function test
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Motor status score
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
medical research council scale of upper extremity
Time Frame: baseline
baseline
Modified Ashworth scale of upeer extremity
Time Frame: baseline
baseline
Pain of upper extremity
Time Frame: from baseline to 4 weeks after baseline
Pain complaints from participants
from baseline to 4 weeks after baseline
Stroke impact scale
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Smoothness
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during point-to-point
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Reach Error
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during point-to-point
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Path Error
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during point-to-point
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Mean velocity
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during point-to-point
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Maximum velocity
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during point-to-point
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Cricle size
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during circle drawing
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Cricle independence
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Kinematics from Inmotion2 during circle drawing
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Intrinsic motivation inventory
Time Frame: 4 weeks after baseline
4 weeks after baseline
stroke rehabilitation motivation scale
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Beck depression index
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 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.

Helpful Links

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

April 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

October 23, 2016

First Submitted That Met QC Criteria

April 1, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2015-01-005

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.

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