Comparisons of Two Types of Armeo Robot for Upper Extremities

Overview

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

Full Title of Study: “Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring – Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2018

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Armeo power
    • Armeo power robot for upper extremity
  • Experimental: Armeo spring
    • Armeo spring robot for upper extremity

Clinical Trial Outcome Measures

Primary Measures

  • Change of Wolf motor function test
    • Time Frame: change from baseline at 4 weeks
    • Change of Wolf motor function test

Secondary Measures

  • Fugl-Meyer Assessment
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Fugl-Meyer Assessment
  • 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)
  • Motor activity log
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Motor activity log
  • 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
  • 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
  • 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
  • % 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
  • 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
  • Beck depression index
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Beck depression index
  • Intrinsic motivation inventory
    • Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline
    • Intrinsic motivation inventory
  • Stroke rehabilitation motivation scale
    • Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline
    • Stroke rehabilitation motivation scale

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Rehabilitation Center, Seoul, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joon-Ho Shin, Team manager – National Rehabilitation Center, Seoul, Korea
  • Overall Official(s)
    • Joon-Ho Shin, MS, Principal Investigator, National Rehabilitation Center
  • Overall Contact(s)
    • Joon-Ho Shin, MS, 82-2-901-1884, asfreelyas@gmail.com

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