Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training

December 4, 2018 updated by: Crystal Massie, Indiana University
The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm Study
This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training.
Other: Robotic gait training
Robotic gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Gait Outcomes
Time Frame: Change from baseline gait speed to post-test up to 6 weeks following the intervention.
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
Time Frame: Change from baseline distance covered to post-test up to 6 weeks following the intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in balance
Time Frame: Change from baseline balance to post-test up to 6 weeks following the intervention.
Balance will be assessed using the Berg Balance Scale.
Change from baseline balance to post-test up to 6 weeks following the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1703719961

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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