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Trial record 12 of 185 for:    functional | Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT03438409
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Crystal Massie, 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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Other: Robotic gait training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438409


Contacts
Contact: Crystal Massie, PhD, OTR 317-278-9617 massiec@iu.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Crystal Massie, PhD, OTR    317-278-9617    massiec@iu.edu   
Sponsors and Collaborators
Indiana University

Responsible Party: Crystal Massie, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03438409     History of Changes
Other Study ID Numbers: 1703719961
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries