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Post-Brain Injury Walking and Balance Recovery Program

Primary Purpose

Acquired Brain Injury, Stroke, Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KineAssist robotic treadmill
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring Gait Rehabilitation, Robotic Treadmill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Body weight greater than 250 pounds (due to robotic device weight restrictions)

Sites / Locations

  • Moody Neurorehabilitation InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gait Rehabilitation

Arm Description

12-16 gait rehabilitation sessions on a robotic treadmill, emphasizing gait scaffolds: endurance, strength, speed, and balance. 3-4 sessions of training for each.

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2023
Last Updated
June 28, 2023
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05934773
Brief Title
Post-Brain Injury Walking and Balance Recovery Program
Official Title
Post-Brain Injury Walking and Balance Recovery Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
August 18, 2023 (Anticipated)
Study Completion Date
August 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Stroke, Traumatic Brain Injury
Keywords
Gait Rehabilitation, Robotic Treadmill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gait Rehabilitation
Arm Type
Experimental
Arm Description
12-16 gait rehabilitation sessions on a robotic treadmill, emphasizing gait scaffolds: endurance, strength, speed, and balance. 3-4 sessions of training for each.
Intervention Type
Device
Intervention Name(s)
KineAssist robotic treadmill
Intervention Description
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).
Primary Outcome Measure Information:
Title
Initial 10-Meter Walk Test (meters/second)
Description
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Time Frame
Before the first training session up to 7 days
Title
Final 10-Meter Walk Test (meters/second)
Description
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Time Frame
After the final training session up to 7 days
Title
Initial Berg Balance Scale
Description
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.
Time Frame
Before the first training session up to 7 days
Title
Final Berg Balance Scale
Description
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.
Time Frame
After the final training session up to 7 days
Title
Initial 6-Minute Walk Test (meters)
Description
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.
Time Frame
Before the first training session up to 7 days
Title
Final 6-Minute Walk Test (meters)
Description
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.
Time Frame
After the final training session up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Body weight greater than 250 pounds (due to robotic device weight restrictions)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David A Brown, PT, Phd
Phone
409-747-3001
Email
davibrow@utmb.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Negar Moradian, MD-MPH
Phone
8327440712
Email
nemoradi@utmb.edu
Facility Information:
Facility Name
Moody Neurorehabilitation Institute
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Brown, PT, Phd
Phone
773-410-0072
Email
davibrow@utmb.edu
First Name & Middle Initial & Last Name & Degree
Negar Moradian, MD-MPH
Phone
8327440712
Email
nemoradi@utmb.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have not yet identified the appropriate platform to share the data
Citations:
PubMed Identifier
21425604
Citation
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.
Results Reference
background
PubMed Identifier
10191370
Citation
Ochi 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.
Results Reference
background
PubMed Identifier
28093370
Citation
Esquenazi 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.
Results Reference
background
PubMed Identifier
25481856
Citation
Wang 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, Avon). 2015 Jan;30(1):40-5. doi: 10.1016/j.clinbiomech.2014.11.006. Epub 2014 Nov 25.
Results Reference
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Post-Brain Injury Walking and Balance Recovery Program

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