Acquired Brain InjuryNCT05934773
Post-Brain Injury Walking and Balance Recovery Program
A study testing KineAssist robotic treadmill in people with Acquired Brain Injury and Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and balance in relation to walking speed, strength, endurance, and balance after traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury, Stroke, Traumatic Brain Injury
- What is being tested?
- KineAssist robotic treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 4 Apr 2025
- Phase
- Interventional
- 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
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 or have a certified interpreter that is English-speaking who will be present for interpretation during the study
- 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 10Show 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
- Body weight greater than 250 pounds (due to robotic device weight restrictions)
Trial locations and contacts
1 site in 1 country.
United States1 site
Moody Neurorehabilitation Institute
Galveston, Texas, 77550
About this study
The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and balance in relation to walking speed, strength, endurance, and balance after traumatic brain injury (TBI).
The aim and primary hypothesis of this research project is:
Read more
Aim) Test and implement a new personalized intervention strategy, in addition to usual and customary care at an inpatient rehabilitation clinic, to improve patient outcomes with secondary conditions associated with impaired balance and walking that typically occur post brain injury. After validation of the locomotor Battery of tests, we will implement a personalized training strategy for individuals based on their battery profile.
Hypothesis) Individuals training with this individualized protocol will demonstrate improved walking and balance outcomes and those with lesser pre-intervention impairment will improve at a greater rate than those with greater pre-intervention impairment.
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 (1, 2). Ochi et al (2) reported that survivors of a TBI may have a gait characterized by an asymmetrical pattern with a prolonged stance phase and a shorter step length for the less-affected limb. Such impairments can interfere with a person's ability to walk and may create dependency on a caregiver or an assistive device. Following hospital discharge, there is a greater fall risk as well as a decrease in physical activity and an increase in sedentary behaviors that lead to deconditioning . Improving a person's ability to walk is often one of the most important parts of their rehabilitation program after a TBI. The importance of repetitive, task-based walking practice to get people to a point where they can walk normally has been recognized and built into the rehabilitation setting. Schmidt and Lee say that motor learning shows a neural specificity of practice because it involves the integration of sensory and motor information, which happens during practice and leads to the sensorimotor solution that leads to accurate, consistent, and skilled movements. It has been shown that rehabilitation based on the ideas of repetitive, intensive, task-oriented training works (2).
Clinicians use their bodies to lift, move, and provide "safety nets" for patients who may be up to three times larger than they are. The intensity and duration of physical therapy sessions are often limited due to the exhaustion of the clinician. Safety concerns sometimes limit the extent to which the clinician is able to challenge the patient as much as possible to enhance learning, because falls and other injuries are not desirable. Robots are tireless, precise devices that can do repetitive motion. In these rather early days in the development of human-machine interactions, there are many unrealized functions that robotic technology can do for rehabilitation (3). The device, the KineAssist MX (https://www.woodway.com/products/kineassist/ ) can facilitate, rather than replace, the efforts of a therapist. This collaborative approach in rehabilitation robotic design was utilized by starting with the end user (clinician) and implementing the feedback received to create a device that assists with functional mobility in stroke rehabilitation. Improvement of walking and balance outcomes in gait-impaired population requires the re-evaluation of current approaches and the testing/implementation of new approaches.
This study will involve the use of a robotic treadmill device to ameliorate physical therapy gait rehabilitation sessions for people with TBI condition and compare their walking abilities before and after our training protocol. In this study, we will be evaluating our novel gait training protocol efficacy for improving TBI individuals walking regarding their endurance, balance, and strength. If it is found that walking performance improves significantly for TBI individuals who are trained by this device, particularly for people with the greatest walking and balance impairment, clinicians and physical therapists can consider implementing this protocol for the TBI population's walking and balance rehabilitation.
- Conditions
- Acquired Brain Injury, Stroke, Traumatic Brain Injury
- Being tested
- KineAssist robotic treadmill
- Keywords
- Gait Rehabilitation, Robotic Treadmill
- Medical subject headings
- Brain Injuries, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KineAssist robotic treadmillDevice
A formal standardization procedure will be used. Prior to testing, the participant's weight, height, age, blood pressure, and resting heart rate will be recorded. Each session will take place over a 1 hour period. All of our participants will have 1 evaluation sessions prior to the training sessions (overground) and 1 evaluation sessions at the end of the training sessions (overground).
Each participant will have the training sessions up to 3 times each week. The total number of training sessions would be 12-16 sessions (based on duration of stay) of robotic treadmill training for, distributed equally over each specific training modality (Endurance x 4, Strength x 4, Speed x 4, and Dynamic Balance x 4).
| Study group | Role | What they receive |
|---|---|---|
| Gait Rehabilitation | Experimental | 12-16 gait rehabilitation sessions on a robotic treadmill, emphasizing gait scaffolds: endurance, strength, speed, and balance. 3-4 sessions of training for each. Receives: Device: KineAssist robotic treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial 10-Meter Walk Test (meters/second)
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Measured: Before the first training session up to 7 days
Final 10-Meter Walk Test (meters/second)
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Measured: After the final training session up to 7 days
Initial Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: Before the first training session up to 7 days
Final Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: After the final training session up to 7 days
Initial 6-Minute Walk Test (meters)
The six-minute walk test (6MWT) is a performance measure that can assess fall risk, walking speed, and walking endurance. The patient is instructed to walk as much distance as possible during the six minutes in an obstructed area in the clinic; breaks were allowed, if needed.
Measured: Before the first training session up to 7 days
Final 6-Minute Walk Test (meters)
The six-minute walk test (6MWT) is a performance measure that can assess fall risk, walking speed, and walking endurance. The patient is instructed to walk as much distance as possible during the six minutes in an obstructed area in the clinic; breaks were allowed, if needed.
Measured: After the final training session up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start18 Aug 2022
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Why it stopped: The study was administratively closed by the Institutional Review Board (IRB) due to the Principal Investigator (PI) no longer being affiliated with the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- The Moody Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934773
- Sponsor's protocol ID
- 22-0162
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet identified the appropriate platform to share the data
Publications
Zhou XR, Fan LH, Yang XP. [Assessment of dynamic posture equilibrium function after traumatic brain injury]. Fa Yi Xue Za Zhi. 2010 Dec;26(6):428-31. Chinese.
PubMed 21425604Ochi F, Esquenazi A, Hirai B, Talaty M. Temporal-spatial feature of gait after traumatic brain injury. J Head Trauma Rehabil. 1999 Apr;14(2):105-15. doi: 10.1097/00001199-199904000-00002.
PubMed 10191370Esquenazi A, Lee S, Wikoff A, Packel A, Toczylowski T, Feeley J. A Comparison of Locomotor Therapy Interventions: Partial-Body Weight-Supported Treadmill, Lokomat, and G-EO Training in People With Traumatic Brain Injury. PM R. 2017 Sep;9(9):839-846. doi: 10.1016/j.pmrj.2016.12.010. Epub 2017 Jan 16.
PubMed 28093370Wang J, Hurt CP, Capo-Lugo CE, Brown DA. Characteristics of horizontal force generation for individuals post-stroke walking against progressive resistive forces. Clin Biomech (Bristol). 2015 Jan;30(1):40-5. doi: 10.1016/j.clinbiomech.2014.11.006. Epub 2014 Nov 25.
PubMed 25481856
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Brain Injury Walking and Balance Recovery Program
- ClinicalTrials.gov ID
- NCT05934773
- Acronym / sponsor ID
- 22-0162
- Conditions
- Acquired Brain Injury, Stroke, Traumatic Brain Injury
- Keywords
- Gait Rehabilitation, Robotic Treadmill
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was administratively closed by the Institutional Review Board (IRB) due to the Principal Investigator (PI) no longer being affiliated with the institution.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- The Moody Foundation
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 7 Jul 2023 (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.
The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and balance in relation to walking speed, strength, endurance, and balance after traumatic brain injury (TBI).
The aim and primary hypothesis of this research project is:
Aim) Test and implement a new personalized intervention strategy, in addition to usual and customary care at an inpatient rehabilitation clinic, to improve patient outcomes with secondary conditions associated with impaired balance and walking that typically occur post brain injury. After validation of the locomotor Battery of tests, we will implement a personalized training strategy for individuals based on their battery profile.
Hypothesis) Individuals training with this individualized protocol will demonstrate improved walking and balance outcomes and those with lesser pre-intervention impairment will improve at a greater rate than those with greater pre-intervention impairment.
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 (1, 2). Ochi et al (2) reported that survivors of a TBI may have a gait characterized by an asymmetrical pattern with a prolonged stance phase and a shorter step length for the less-affected limb. Such impairments can interfere with a person's ability to walk and may create dependency on a caregiver or an assistive device. Following hospital discharge, there is a greater fall risk as well as a decrease in physical activity and an increase in sedentary behaviors that lead to deconditioning . Improving a person's ability to walk is often one of the most important parts of their rehabilitation program after a TBI. The importance of repetitive, task-based walking practice to get people to a point where they can walk normally has been recognized and built into the rehabilitation setting. Schmidt and Lee say that motor learning shows a neural specificity of practice because it involves the integration of sensory and motor information, which happens during practice and leads to the sensorimotor solution that leads to accurate, consistent, and skilled movements. It has been shown that rehabilitation based on the ideas of repetitive, intensive, task-oriented training works (2).
Clinicians use their bodies to lift, move, and provide "safety nets" for patients who may be up to three times larger than they are. The intensity and duration of physical therapy sessions are often limited due to the exhaustion of the clinician. Safety concerns sometimes limit the extent to which the clinician is able to challenge the patient as much as possible to enhance learning, because falls and other injuries are not desirable. Robots are tireless, precise devices that can do repetitive motion. In these rather early days in the development of human-machine interactions, there are many unrealized functions that robotic technology can do for rehabilitation (3). The device, the KineAssist MX (https://www.woodway.com/products/kineassist/ ) can facilitate, rather than replace, the efforts of a therapist. This collaborative approach in rehabilitation robotic design was utilized by starting with the end user (clinician) and implementing the feedback received to create a device that assists with functional mobility in stroke rehabilitation. Improvement of walking and balance outcomes in gait-impaired population requires the re-evaluation of current approaches and the testing/implementation of new approaches.
This study will involve the use of a robotic treadmill device to ameliorate physical therapy gait rehabilitation sessions for people with TBI condition and compare their walking abilities before and after our training protocol. In this study, we will be evaluating our novel gait training protocol efficacy for improving TBI individuals walking regarding their endurance, balance, and strength. If it is found that walking performance improves significantly for TBI individuals who are trained by this device, particularly for people with the greatest walking and balance impairment, clinicians and physical therapists can consider implementing this protocol for the TBI population's walking and balance rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait Rehabilitation | Experimental | Device: KineAssist robotic treadmill12-16 gait rehabilitation sessions on a robotic treadmill, emphasizing gait scaffolds: endurance, strength, speed, and balance. 3-4 sessions of training for each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 (10 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 |
|---|---|---|
| KineAssist robotic treadmillA formal standardization procedure will be used. Prior to testing, the participant's weight, height, age, blood pressure, and resting heart rate will be recorded. Each session will take place over a 1 hour period. All of our participants will have 1 evaluation sessions prior to the training sessions (overground) and 1 evaluation sessions at the end of the training sessions (overground). Each participant will have the training sessions up to 3 times each week. The total number of training sessions would be 12-16 sessions (based on duration of stay) of robotic treadmill training for, distributed equally over each specific training modality (Endurance x 4, Strength x 4, Speed x 4, and Dynamic Balance x 4). | Device | Gait Rehabilitation |
Primary outcome
Initial 10-Meter Walk Test (meters/second)
Time frame: Before the first training session up to 7 days
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Final 10-Meter Walk Test (meters/second)
Time frame: After the final training session up to 7 days
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Initial Berg Balance Scale
Time frame: Before the first training session up to 7 days
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Final Berg Balance Scale
Time frame: After the final training session up to 7 days
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Initial 6-Minute Walk Test (meters)
Time frame: Before the first training session up to 7 days
The six-minute walk test (6MWT) is a performance measure that can assess fall risk, walking speed, and walking endurance. The patient is instructed to walk as much distance as possible during the six minutes in an obstructed area in the clinic; breaks were allowed, if needed.
Final 6-Minute Walk Test (meters)
Time frame: After the final training session up to 7 days
The six-minute walk test (6MWT) is a performance measure that can assess fall risk, walking speed, and walking endurance. The patient is instructed to walk as much distance as possible during the six minutes in an obstructed area in the clinic; breaks were allowed, if needed.
Results and safety
The study was stopped early (reason given: The study was administratively closed by the Institutional Review Board (IRB) due to the Principal Investigator (PI) no longer being affiliated with the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 21425604Zhou XR, Fan LH, Yang XP. [Assessment of dynamic posture equilibrium function after traumatic brain injury]. Fa Yi Xue Za Zhi. 2010 Dec;26(6):428-31. Chinese.
- Background: PubMed 10191370Ochi F, Esquenazi A, Hirai B, Talaty M. Temporal-spatial feature of gait after traumatic brain injury. J Head Trauma Rehabil. 1999 Apr;14(2):105-15. doi: 10.1097/00001199-199904000-00002.
- Background: PubMed 28093370Esquenazi A, Lee S, Wikoff A, Packel A, Toczylowski T, Feeley J. A Comparison of Locomotor Therapy Interventions: Partial-Body Weight-Supported Treadmill, Lokomat, and G-EO Training in People With Traumatic Brain Injury. PM R. 2017 Sep;9(9):839-846. doi: 10.1016/j.pmrj.2016.12.010. Epub 2017 Jan 16.
- Background: PubMed 25481856Wang J, Hurt CP, Capo-Lugo CE, Brown DA. Characteristics of horizontal force generation for individuals post-stroke walking against progressive resistive forces. Clin Biomech (Bristol). 2015 Jan;30(1):40-5. doi: 10.1016/j.clinbiomech.2014.11.006. Epub 2014 Nov 25.
- Individual participant dataSharing planned: Undecided. We have not yet identified the appropriate platform to share the data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KineAssist robotic treadmill in people with Acquired Brain Injury and Stroke, 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 10 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: stopped early, as of the sponsor's last update on 24 Dec 2025. 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 was stopped early (reason given: The study was administratively closed by the Institutional Review Board (IRB) due to the Principal Investigator (PI) no longer being affiliated with the institution.). Results are not available in the source record.
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?
Initial 10-Meter Walk Test (meters/second) (time frame: Before the first training session up to 7 days). 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?
On the ClinicalTrials.gov record for NCT05934773, which also lists 4 linked publications.
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 24 Dec 2025.