Comparisons of Two Types of Armeo Robot for Upper Extremities

Not Applicable

• Conditions: Stroke
• Interventions: Device: Armeo power; Device: Armeo spring

• Registration Number: NCT03465267
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

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.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-07
• Last Update Submitted: 2018-03-07
• Study First Posted: 2018-03-14
• Last Update Posted: 2018-03-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Armeo power	Armeo power	Armeo power robot for upper extremity
Armeo spring	Armeo spring	Armeo spring robot for upper extremity

Primary Outcome Measures

Name	Time	Method
Change of Wolf motor function test	change from baseline at 4 weeks	Change of Wolf motor function test

Secondary Outcome Measures

Name	Time	Method
Stroke impact scale	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	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Motor activity log
Mean velocity of upper extremity during reaching task	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	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	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	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	surface EMG of upper extremity during reaching task
Fugl-Meyer Assessment	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Fugl-Meyer Assessment
Intrinsic motivation inventory	baseline, 4 weeks after baseline, 8 weeks after baseline	Intrinsic motivation inventory
Stroke rehabilitation motivation scale	baseline, 4 weeks after baseline, 8 weeks after baseline	Stroke rehabilitation motivation scale
Behavioral activation system/behavioral inhibition system scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Behavioral activation system subscale, behavioral inhibition system subscale
Beck depression index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Beck depression index

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of