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TerminatedNCT03438409Updated Dec 6, 2018

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

An interventional study of Robotic gait training in TBI (Traumatic Brain Injury), sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-06.

Sponsored by Indiana University · Not applicable, Interventional, and Treatment

Why this study was terminated
Changes in personnel at Institution.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • TBI (Traumatic Brain Injury)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • currently receiving outpatient therapy
  • medically unstable
  • body weight > 150 kgs
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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

Interventions

  • OtherRobotic gait training

    Robotic gait training

05

What researchers measure

Primary outcomes

  1. Change in Functional Gait Outcomes

    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.

  2. Change in Endurance

    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 outcomes

  1. Change in balance

    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.

06

Study locations

1 site
  • Indiana University
    Indianapolis, Indiana 46202, United States
07

Registry details

Key details

Study ID
NCT03438409
Lead sponsor
Indiana University
Responsible party
Crystal Massie (Assistant Professor, Indiana University) — Principal investigator
First posted
Feb 19, 2018
Start date
Jul 1, 2017
Primary completion
Jul 30, 2018
Completion
Jul 30, 2018
Last update
Dec 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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