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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438409
Recruitment Status : Terminated (Changes in personnel at Institution.)
First Posted : February 19, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Crystal Massie, Indiana University

Tracking Information
First Submitted Date  ICMJE August 4, 2017
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • 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 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03438409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Official Title  ICMJE Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE TBI (Traumatic Brain Injury)
Intervention  ICMJE Other: Robotic gait training
Robotic gait training
Study Arms  ICMJE Experimental: Single Arm Study
This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training.
Intervention: Other: Robotic gait training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 4, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
20
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438409
Other Study ID Numbers  ICMJE 1703719961
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Crystal Massie, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indiana University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP