Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05057377
Study type Observational
Source The University of Texas Medical Branch, Galveston
Contact David Brown
Phone 4097473001
Email [email protected]
Status Recruiting
Phase
Start date September 22, 2021
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04111549 - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth N/A
Recruiting NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Not yet recruiting NCT02776488 - Exogenous Lactate Infusion in Traumatic Brain Injury (ELI-TBI) Phase 2
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT04559724 - Gait Training Through a New Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes N/A
Not yet recruiting NCT04515420 - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Recruiting NCT04331392 - Online Memory Intervention for Individuals With Traumatic Brain Injury N/A
Recruiting NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Recruiting NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Not yet recruiting NCT04893837 - Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
Completed NCT03671083 - Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Enrolling by invitation NCT03867513 - The Role of MEG in Assessment and Diagnosis In mTBI
Enrolling by invitation NCT02525432 - Autologous Stem Cell Study for Adult TBI (Phase 2b) Phase 2
Enrolling by invitation NCT02652598 - Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD Phase 2
Completed NCT03648476 - Intervention to Change Attributions That Are Negative (ICAN) N/A
Active, not recruiting NCT04166617 - Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury N/A