Brain Injuries, TraumaticNCT05057377
Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Standard Overground Assessment and Robotic Safety-Environment Assessment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, post-TBI individuals currently enrolled at the Moody Neurorehabilitation Institute.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Moody Neurorehabilitation Institute at Galveston
Galveston, Texas, 77550
About this study
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.
Read the detailed description
Traumatic brain injury due to trauma and/or neurologic disease is a leading cause of long-term disability in the United States. Balance impairments observed within the post-TBI population can greatly impact walking abilities and pose a variety of challenges. Following hospital discharge, there is a greater fall risk as well as a decrease in physical activity and increase in sedentary behaviors that lead to deconditioning.
It is difficult to determine the extent of what a person is capable of doing using current overground assessment methods, which are the current standard means of physical capability measurements (i.e. 6-minute walk test, 5 times sit-to-stand, 10-meter walk test). Improvement of walking and balance outcomes in this population requires the re-evaluation of current approaches and the testing/implementation of new approaches. This will allow more appropriate assessment of baseline walking abilities in order to apply the appropriate amount of challenge during rehabilitation training. This study will involve the use of a robotic treadmill device in order to determine maximum walking capacities of participants and compare these capacities to standard overground assessments. It has been shown that walking speeds overground are correlated with walking speeds on a robotic device (and even specifically on the KineAssist-MX, which will be used for this project). If it is found that maximum capacities be greater on the robotic device, rehabilitation training goals can be more appropriately tailored to these participants.
The aims and hypotheses of this research project are:
Aim 1) Assess function at preferred performance in an overground environment vs. a safety-enhanced robotic environment to establish concurrent validity.
Hypothesis 1) Participants with the highest overground performances (strength, speed, and endurance) will have the highest performances on the KineAssist-MX and vice versa.
Aim 2) Assess maximum capacities of participants over ground vs. in the safety-enhanced robotic environment to establish content validity.
Hypothesis 2) Maximum capacity will be higher in the safety-enhanced robotic environment than overground and vice versa. Therefore, people will be able to do more in the robotic environment than overground.
Aim 3) Assess the capacities of individuals across different baseline functional strata to establish usability.
Hypothesis 3) Individuals in the lower quadrants of baseline function will have lower maximum capacities in the safety-enhanced robotic environment.
This study will occur over a two-day period of time during which participants will undergo overground assessments during day 1 and robotic safety-environment assessments during day 2. There will be no interventions implemented.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Standard Overground Assessment, Robotic Safety-Environment Assessment
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Overground AssessmentDiagnostic 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).
Robotic Safety-Environment AssessmentDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Standard Overground Assessment; Diagnostic Test: Robotic Safety-Environment Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-Meter Walk Test-Overground
The 10-meter walk test assess walking speed in meters per second over a short duration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start22 Sep 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Brown, PhD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057377
- Sponsor's protocol ID
- 20-0300
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05057377
- Acronym / sponsor ID
- 20-0300
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traumatic brain injury due to trauma and/or neurologic disease is a leading cause of long-term disability in the United States. Balance impairments observed within the post-TBI population can greatly impact walking abilities and pose a variety of challenges. Following hospital discharge, there is a greater fall risk as well as a decrease in physical activity and increase in sedentary behaviors that lead to deconditioning.
It is difficult to determine the extent of what a person is capable of doing using current overground assessment methods, which are the current standard means of physical capability measurements (i.e. 6-minute walk test, 5 times sit-to-stand, 10-meter walk test). Improvement of walking and balance outcomes in this population requires the re-evaluation of current approaches and the testing/implementation of new approaches. This will allow more appropriate assessment of baseline walking abilities in order to apply the appropriate amount of challenge during rehabilitation training. This study will involve the use of a robotic treadmill device in order to determine maximum walking capacities of participants and compare these capacities to standard overground assessments. It has been shown that walking speeds overground are correlated with walking speeds on a robotic device (and even specifically on the KineAssist-MX, which will be used for this project). If it is found that maximum capacities be greater on the robotic device, rehabilitation training goals can be more appropriately tailored to these participants.
The aims and hypotheses of this research project are:
Aim 1) Assess function at preferred performance in an overground environment vs. a safety-enhanced robotic environment to establish concurrent validity.
Hypothesis 1) Participants with the highest overground performances (strength, speed, and endurance) will have the highest performances on the KineAssist-MX and vice versa.
Aim 2) Assess maximum capacities of participants over ground vs. in the safety-enhanced robotic environment to establish content validity.
Hypothesis 2) Maximum capacity will be higher in the safety-enhanced robotic environment than overground and vice versa. Therefore, people will be able to do more in the robotic environment than overground.
Aim 3) Assess the capacities of individuals across different baseline functional strata to establish usability.
Hypothesis 3) Individuals in the lower quadrants of baseline function will have lower maximum capacities in the safety-enhanced robotic environment.
This study will occur over a two-day period of time during which participants will undergo overground assessments during day 1 and robotic safety-environment assessments during day 2. There will be no interventions implemented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-TBI Participants | – | Diagnostic Test: Standard Overground Assessment, Diagnostic Test: Robotic Safety-Environment AssessmentOver 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, post-TBI individuals currently enrolled at the Moody Neurorehabilitation Institute.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Overground AssessmentThe 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). | Diagnostic test | Post-TBI Participants |
| Robotic Safety-Environment AssessmentThe 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). | Diagnostic test | Post-TBI Participants |
Primary outcome
Change in 10-Meter Walk Test-Overground
Time frame: Baseline, pre-intervention.
The 10-meter walk test assess walking speed in meters per second over a short duration.
Change in 5x Sitting to Standing Resistance Test
Time frame: Baseline, pre-intervention.
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.
6-Minute Walk Test
Time frame: Baseline, pre-intervention.
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.
Top Walking Speed/Max Tolerated using Robotic Device
Time frame: During the intervention.
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.
Deadband Resistance/Max Tolerated using Robotic Device
Time frame: During the intervention.
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.
6-Minute Walk Test using Robotic Device
Time frame: During the intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brown, PhD principal investigator
The University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10-Meter Walk Test-Overground (time frame: Baseline, pre-intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.