NCT02680691

Brief Summary

The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

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, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

February 9, 2016

Last Update Submit

March 1, 2018

Conditions

Stroke

Keywords

infratentorial strokerobotpostural balanceRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Berg Balance Scale at 4 Weeks

    Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life

    Baseline and 4 weeks from baseline

Secondary Outcomes (8)

  • Berg Balance Scale

    Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  • Trunk impairment scale

    Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  • Functional Ambulation Category

    Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  • 10m walk test

    Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  • Fugl-Meyer Assessment

    Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  • +3 more secondary outcomes

Study Arms (2)

Robot, then conventional training

EXPERIMENTAL

Robot assisted gait training 4 weeks after conventional gait training

Other: Robot, then conventional training

Conventional, then robot training

ACTIVE COMPARATOR

Conventional gait training 4 weeks after robot assisted gait training

Other: Conventional, then robot training

Interventions

Robot, then conventional trainingOTHER

Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline

Robot, then conventional training
Conventional, then robot trainingOTHER

Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline

Conventional, then robot training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with infratentorial stroke
  • Cognitively intact enough to understand and follow the instructions from the investigator

You may not qualify if:

  • chronic neurological pathology
  • orthopedic injuries
  • femur lengths of less than 34cm
  • severely limited range of lower extremity joint motion
  • medical instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

Location

Related Publications (1)

  • Kim HY, Shin JH, Yang SP, Shin MA, Lee SH. Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2019 Jul 29;16(1):99. doi: 10.1186/s12984-019-0553-5.

    PMID: 31358017DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 11, 2016

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

March 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)