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Comparisons of Two Types of Armeo Robot for Upper Extremities

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03465267
Enrollment
20
Registered
2018-03-14
Start date
2017-06-01
Completion date
2018-12-31
Last updated
2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, upper extremity rehabilitation robot, stroke rehabilitation

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.

Interventions

DEVICEArmeo 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.

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.

Sponsors

National Rehabilitation Center, Seoul, Korea
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor does not know the allocation of participants.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Wolf motor function testchange from baseline at 4 weeksChange of Wolf motor function test

Secondary

MeasureTime frameDescription
Stroke impact scalebaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineStroke impact scale (Health-related quality of life measurements in stroke patients)
Motor activity logbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineMotor activity log
Mean velocity of upper extremity during reaching taskbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineCurvature of the magnetic sensor trajectory (Kinematics of upper extremity)during reaching task
Curvature of upper extremity during reaching taskbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineCurvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Jerk of upper extremity during reaching taskbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineJerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Fugl-Meyer Assessmentbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineFugl-Meyer Assessment
Behavioral activation system/behavioral inhibition system scalebaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineBehavioral activation system subscale, behavioral inhibition system subscale
Beck depression indexbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselineBeck depression index
Intrinsic motivation inventorybaseline, 4 weeks after baseline, 8 weeks after baselineIntrinsic motivation inventory
Stroke rehabilitation motivation scalebaseline, 4 weeks after baseline, 8 weeks after baselineStroke rehabilitation motivation scale
% maximal voluntary contraction of upper extremity muscles during reaching taskbaseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baselinesurface EMG of upper extremity during reaching task

Countries

South Korea

Contacts

Primary ContactJoon-Ho Shin, MS
asfreelyas@gmail.com82-2-901-1884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026