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

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03438409
• Other study ID #: 1703719961
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: December 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

Other:
• Robotic gait training
Robotic gait training

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in balance	Balance will be assessed using the Berg Balance Scale.	Change from baseline balance to post-test up to 6 weeks following the intervention.