Back to resultsImproving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Primary Purpose
TBI (Traumatic Brain Injury)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic gait training
Sponsored by
About this trial
This is an interventional treatment trial for TBI (Traumatic Brain Injury)
Eligibility Criteria
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
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm Study
Arm Description
This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training.
Outcomes
Primary Outcome Measures
Change in Functional Gait Outcomes
Gait speed will be assessed using a gait mat.
Change in Endurance
Endurance will be assessed using the 6-minute walk test.
Secondary Outcome Measures
Change in balance
Balance will be assessed using the Berg Balance Scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03438409
Brief Title
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Official Title
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Changes in personnel at Institution.
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm Study
Arm Type
Experimental
Arm Description
This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training.
Intervention Type
Other
Intervention Name(s)
Robotic gait training
Intervention Description
Robotic gait training
Primary Outcome Measure Information:
Title
Change in Functional Gait Outcomes
Description
Gait speed will be assessed using a gait mat.
Time Frame
Change from baseline gait speed to post-test up to 6 weeks following the intervention.
Title
Change in Endurance
Description
Endurance will be assessed using the 6-minute walk test.
Time Frame
Change from baseline distance covered to post-test up to 6 weeks following the intervention.
Secondary Outcome Measure Information:
Title
Change in balance
Description
Balance will be assessed using the Berg Balance Scale.
Time Frame
Change from baseline balance to post-test up to 6 weeks following the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
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Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
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