NCT03991364

Brief Summary

Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.

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 Jul 2019

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

First Submitted

Initial submission to the registry

June 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

June 18, 2019

Last Update Submit

June 18, 2019

Conditions

Keywords

Robot-assisted gait trainingstrokegait speed

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure (EE)

    EE(kcal/min): energy expenditure per minute

    2 weeks after baseline

Secondary Outcomes (11)

  • Energy expenditure (EE)

    baseline, 1 weeks after baseline, 3 weeks after baseline

  • Heart rate (HR)

    baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline

  • Volume of Oxygen (VO2)

    baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline

  • Respiratory Quotient (R)

    baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline

  • Metabolic equivalent (METS)

    baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline

  • +6 more secondary outcomes

Study Arms (2)

Constant gait speed group

EXPERIMENTAL

experimental group that applied the speed of the robot-assisted gait training constantly

Other: Constant gait speed group

Increasing gait speed group

OTHER

control group that applied the gradual increase of the speed of the robot-assisted gait training

Other: Increasing gait speed group

Interventions

The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.

Constant gait speed group

The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.

Increasing gait speed group

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
  • 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

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 19, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations