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

Not Applicable

Terminated

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Other: Robotic gait training

• Registration Number: NCT03438409
• Lead Sponsor: Indiana University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	Robotic gait training	This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training.

Primary Outcome Measures

Name	Time	Method
Change in Functional Gait Outcomes	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 in Endurance	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.

Secondary Outcome Measures

Name	Time	Method
Change in balance	Change from baseline balance to post-test up to 6 weeks following the intervention.	Balance will be assessed using the Berg Balance Scale.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States