NCT02569190

Brief Summary

Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable stroke

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

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

September 18, 2015

Last Update Submit

April 28, 2016

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention

    at the first day of intervention and 8 weeks after the first day

Secondary Outcomes (4)

  • Functional ambulation category

    at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

  • Fugl-meyer assessment

    at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

  • Medical research council

    at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

  • Trunk control test

    at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

Study Arms (1)

Walkbot

EXPERIMENTAL

Receive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all.

Device: Walkbot

Interventions

WalkbotDEVICE

Robot assisted gait training

Walkbot

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First stroke attack
  • Within 3 months after stroke onset
  • Supratentorial stroke
  • Unilateral stroke

You may not qualify if:

  • Bilateral stroke
  • infratentorial stroke
  • Cognitive disabilities or serious psychiatric illness.
  • Difficulty in walking due to orthopedic problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Health Service Medical Center

Seoul, Gangdong-gu, 05368, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dae Hyun Kim, Master

    Veterans hospital, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 18, 2015

First Posted

October 6, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

KR(1)