NCT03341065

Brief Summary

Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial

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 Apr 2016

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

April 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

October 22, 2017

Last Update Submit

November 13, 2017

Conditions

StrokeRobot Assisted Gait Training

Outcome Measures

Primary Outcomes (1)

  • Change of Range of motion of ankle joint at 4 weeks

    ankle joint motion of sagittal plane during gait

    4 weeks from baseline

Secondary Outcomes (12)

  • Trunk impairment scale

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Berg Balance Scale

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • 10m walk test

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Fugl-Meyer Assessment

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Korean version of Falls efficacy scale

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • +7 more secondary outcomes

Study Arms (2)

exoskeleton type robot

EXPERIMENTAL

exoskeleton type robot assisted gait training (Lokomat orthosis)

Device: exoskeleton type robot

end-effector type robot

EXPERIMENTAL

end-effector type robot assisted gait training (G-EO system)

Device: end-effector type robot

Interventions

exoskeleton type robotDEVICE
exoskeleton type robot
end-effector type robotDEVICE
end-effector type robot

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Ankle dorsiflexor strength: medical research council scale 2 or 3
  • Functional ambulation category score 3

You may not qualify if:

  • History of surgery of affected lower limb
  • Fracture of affected lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

RECRUITING

Related Links

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
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2017

First Posted

November 14, 2017

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)