TERMINATED

Post-Brain Injury Walking and Balance Recovery Program

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Post-Brain Injury Walking and Balance Recovery Program

Quick Facts

Study Start:2022-08-18
Study Completion:2025-04-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05934773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ages 18 years and older
  2. * All demographic groups will be invited to participate and would have equal access
  3. * Post-TBI individuals currently enrolled at the Moody Neurorehabilitation Institute
  4. * Ambulatory with or without assistive devices
  5. * Subjects with expressive aphasia in the case of a caregiver able to provide assistance when needed
  6. * English-speaking or have a certified interpreter that is English-speaking who will be present for interpretation during the study
  7. * Medically stable (controlled hypertension, no arrhythmia, stable cardiovascular status)
  8. * Able to provide written informed consent
  1. * Subjects with loss of lower limb
  2. * History of serious cardiac disease (e.g., myocardial infarction)
  3. * Uncontrolled blood pressure (systolic pressure \>140 mmHg, diastolic blood pressure \>90 mmHg)
  4. * Subjects with receptive aphasia
  5. * Presence of cerebellar and brainstem deficits
  6. * Severe cognitive disorder
  7. * Uncontrolled respiratory or metabolic disorders
  8. * Major or acute musculoskeletal problems
  9. * Spasticity management that included phenol block injections within 12 months or botulinum toxin injections within 4 months of the study
  10. * Body weight greater than 250 pounds (due to robotic device weight restrictions)

Contacts and Locations

Study Locations (Sites)

Moody Neurorehabilitation Institute
Galveston, Texas, 77550
United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-18
Study Completion Date2025-04-04

Study Record Updates

Study Start Date2022-08-18
Study Completion Date2025-04-04

Terms related to this study

Keywords Provided by Researchers

  • Gait Rehabilitation
  • Robotic Treadmill

Additional Relevant MeSH Terms

  • Acquired Brain Injury
  • Stroke
  • Traumatic Brain Injury