Post-Brain Injury Walking and Balance Recovery Program

NCT05934773 | Terminated

• 1 other identifier: 22-0162
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Stroke; Traumatic Brain Injury

Keywords

Gait Rehabilitation; Robotic Treadmill

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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.

  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.

  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.

  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.

  After the final training session up to 7 days

Study Arms (1)

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.

Device: KineAssist robotic treadmill

Interventions

KineAssist robotic treadmill DEVICE

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).

Gait Rehabilitation

Eligibility Criteria

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

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 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

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
• Body weight greater than 250 pounds (due to robotic device weight restrictions)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• The Moody Foundation: collaborator

Study Sites (1)

Moody Neurorehabilitation Institute

Galveston, Texas, 77550, United States

Location

Related Publications (4)

• 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.

  PMID: 21425604 BACKGROUND

• 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.

  PMID: 10191370 BACKGROUND

• 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.

  PMID: 28093370 BACKGROUND

• 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). 2015 Jan;30(1):40-5. doi: 10.1016/j.clinbiomech.2014.11.006. Epub 2014 Nov 25.

  PMID: 25481856 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: August 18, 2022
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)