Comparisons of Two Types of Armeo Robot for Upper Extremities

NCT ID: NCT03465267

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessor does not know the allocation of participants.

Study Groups

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Armeo power

Armeo power robot for upper extremity

Group Type EXPERIMENTAL

Armeo power

Intervention Type DEVICE

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

Armeo spring robot for upper extremity

Group Type EXPERIMENTAL

Armeo spring

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Joon-Ho Shin

Team manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon-Ho Shin, MS

Role: PRINCIPAL_INVESTIGATOR

National Rehabilitation Center

Locations

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National Rehabilitation Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joon-Ho Shin, MS

Role: CONTACT

82-2-901-1884

Facility Contacts

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Joon-Ho Shin, MS

Role: primary

References

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Park JH, Park G, Kim HY, Lee JY, Ham Y, Hwang D, Kwon S, Shin JH. A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study. J Neuroeng Rehabil. 2020 Oct 19;17(1):137. doi: 10.1186/s12984-020-00763-6.

Reference Type DERIVED
PMID: 33076952 (View on PubMed)

Other Identifiers

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NRC-2017-01-007

Identifier Type: -

Identifier Source: org_study_id

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