Comparisons of Two Types of Armeo Robot for Upper Extremities

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465267
• Other study ID #: NRC-2017-01-007
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2018
• Last updated: March 7, 2018
• Start date: June 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Wolf motor function test	Change of Wolf motor function test	change from baseline at 4 weeks
Secondary	Fugl-Meyer Assessment	Fugl-Meyer Assessment	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Stroke impact scale	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
Secondary	Motor activity log	Motor activity log	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Mean velocity of upper extremity during reaching task	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
Secondary	Curvature of upper extremity during reaching task	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
Secondary	Jerk of upper extremity during reaching task	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
Secondary	% maximal voluntary contraction of upper extremity muscles during reaching task	surface EMG of upper extremity during reaching task	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Behavioral activation system/behavioral inhibition system scale	Behavioral activation system subscale, behavioral inhibition system subscale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Beck depression index	Beck depression index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Intrinsic motivation inventory	Intrinsic motivation inventory	baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Stroke rehabilitation motivation scale	Stroke rehabilitation motivation scale	baseline, 4 weeks after baseline, 8 weeks after baseline