NCT03465267

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

March 1, 2018

Last Update Submit

March 7, 2018

Conditions

Stroke

Keywords

strokeupper extremity rehabilitation robotstroke rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change of Wolf motor function test

    Change of Wolf motor function test

    change from baseline at 4 weeks

Secondary Outcomes (11)

  • Fugl-Meyer Assessment

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Stroke impact scale

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Motor activity log

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Mean velocity of upper extremity during reaching task

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Curvature of upper extremity during reaching task

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • +6 more secondary outcomes

Study Arms (2)

Armeo power

EXPERIMENTAL

Armeo power robot for upper extremity

Device: Armeo power

Armeo spring

EXPERIMENTAL

Armeo spring robot for upper extremity

Device: Armeo spring

Interventions

Armeo powerDEVICE

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 power
Armeo springDEVICE

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.

Armeo spring

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Onset ≥ 3 months
  • ≤ Fugl-Meyer Assessment score ≤ 50
  • ≤ 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

You may not qualify if:

  • History of surgery of affected upper limb
  • Fracture of affected upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33076952DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin, MS

CONTACT

82-2-901-1884asfreelyas@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor does not know the allocation of participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 14, 2018

Study Start

June 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)