NCT03438409

Brief Summary

The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

August 4, 2017

Last Update Submit

December 4, 2018

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (2)

  • Change in Functional Gait Outcomes

    Gait speed will be assessed using a gait mat.

    Change from baseline gait speed to post-test up to 6 weeks following the intervention.

  • Change in Endurance

    Endurance will be assessed using the 6-minute walk test.

    Change from baseline distance covered to post-test up to 6 weeks following the intervention.

Secondary Outcomes (1)

  • Change in balance

    Change from baseline balance to post-test up to 6 weeks following the intervention.

Study Arms (1)

Single Arm Study

EXPERIMENTAL

This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training.

Other: Robotic gait training

Interventions

Robotic gait trainingOTHER

Robotic gait training

Single Arm Study

Eligibility Criteria

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

You may qualify if:

  • over 18 years of age
  • traumatic brain injury at least 6 months prior to study

You may not qualify if:

  • currently receiving outpatient therapy
  • medically unstable
  • body weight \> 150 kgs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

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
Assistant Professor

Study Record Dates

First Submitted

August 4, 2017

First Posted

February 19, 2018

Study Start

July 1, 2017

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

US(1)