Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury

NCT05057377 | Completed

• 1 other identifier: 20-0300
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic brain injury (TBI) due to trauma and/or neurologic disease is a leading cause of long-term disability in the United States. The loss of balance for people with a traumatic brain injury can have a large effect on their walking abilities and this can come with a number of challenges. There is a greater risk of falling after being discharged from the hospital. In addition, people are more likely to become sedentary after TBI, which leads to the loss of muscle strength. To help provide the best care, clinicians need accurate measurements when people begin their therapy, as well as throughout to ensure they are making appropriate progress. The tests currently used by clinicians may not provide the most accurate measurements that show what a person is capable of physically doing. The study you are being asked to participate in aims to provide more accurate measurements by using a robotic treadmill device and by assessing motivating factors that are important to you. The treadmill device will allow us to more accurately test your walking ability in a safe, fall-free environment.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (6)

• Change in 10-Meter Walk Test-Overground

  The 10-meter walk test assess walking speed in meters per second over a short duration.

  Baseline, pre-intervention.

• Change in 5x Sitting to Standing Resistance Test

  In order to measure walking strength, participants will be asked to perform a Sit-to-Stand test. Beginning from a sitting position, a participant is asked to stand and return to a seated position. They will be asked to repeat this procedure 5 times.

  Baseline, pre-intervention.

• 6-Minute Walk Test

  In order to measure walking endurance, participants will be asked to walk as far as they are able to comfortably walk during a 6 minute time period, with the total distance (in meters) being the outcome.

  Baseline, pre-intervention.

• Top Walking Speed/Max Tolerated using Robotic Device

  In order to measure walking speed, and with the assistance of the safety enhanced robotic-treadmill device, a participant's maximum walking speed will be measured in meters per second.

  During the intervention.

• Deadband Resistance/Max Tolerated using Robotic Device

  In order to measure walking strength, participants will be asked to walk on the robotic-treadmill device as fast as they can over a series of trials. Resistance of the treadmill will be increased until a maximum is reached and recorded.

  During the intervention.

• 6-Minute Walk Test using Robotic Device

  In order to measure walking endurance, participants will be asked to walk as far as they are able to comfortably walk during a 6 minute time period while using the robotic-treadmill device.

  During the intervention.

Study Arms (1)

Post-TBI Participants

Over a 2-day period post-TBI adults age 18 years and older, will undergo overground assessments with a questionnaire regarding motivation during day 1, followed by robotic safety-environment assessments during day 2.

Diagnostic Test: Standard Overground Assessment; Diagnostic Test: Robotic Safety-Environment Assessment

Interventions

Standard Overground Assessment DIAGNOSTIC_TEST

The standard overground methods to assess three main components of walking are the 10 Meter Walk Test (meters/second, used to measure speed), 5x Sit-to-Stand (seconds, used to measure strength), and the 6-Minute Walk Test (meters, used to measure endurance).

Post-TBI Participants

Robotic Safety-Environment Assessment DIAGNOSTIC_TEST

The methods for assessment of the three main components of walking in the robotic environment will be the maximum walking speed tolerated (meters/second, to measure speed), deadband resistance (kilograms, to measure strength), and the 6-minute walk test (meters, to measure endurance).

Post-TBI Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult, post-TBI individuals currently enrolled at the Moody Neurorehabilitation Institute.

You may qualify if:

• Adults ages 18 years and older
• All demographic groups will be invited to participate and would have equal access
• Post-TBI individuals currently enrolled at the Moody Neurorehabilitation Institute
• Ambulatory with or without assistive devices
• Subjects with expressive aphasia in the case of a caregiver able to provide assistance when needed
• English-speaking only
• Medically stable (controlled hypertension, no arrhythmia, stable cardiovascular status)
• Able to provide written informed consent

You may not qualify if:

• Subjects with loss of lower limb
• History of serious cardiac disease (e.g., myocardial infarction)
• Uncontrolled blood pressure (systolic pressure \>140 mmHg, diastolic blood pressure \>90 mmHg)
• Subjects with receptive aphasia
• Presence of cerebellar and brainstem deficits
• Severe cognitive disorder
• Uncontrolled respiratory or metabolic disorders
• Major or acute musculoskeletal problems
• Spasticity management that included phenol block injections within 12 months or botulinum toxin injections within 4 months of the study
• Participants undergoing any rehabilitation therapy during the timeframe of this study.
• Body weight greater than 250 pounds (due to robotic device weight restrictions)
• Non-English speaking individuals

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Moody Neurorehabilitation Institute at Galveston

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Brown, PhD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 27, 2021
• Study Start: September 22, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

US (1)