Walking and Balance Post-TBI

NCT01418976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2013-04-26

No results posted yet for this study

Summary

This is a case series study evaluating the feasibility and dosage of Intensive Mobility Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury (TBI) causing significant locomotor impairment, who meet these specific criteria, will be recruited. Location and nature of neural insult will be determined by multimodal Magnetic Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per day for 20 days, focusing on gait and balance. Locomotion and balance will be comprehensively tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT. This study will determine the feasibility of this intervention in the population of TBI patients, allow an estimate of effect size and provide initial information on possible neural predictors of success. Furthermore the investigators will be able to determine whether the dosage of 10 days is sufficient or whether significant improvements are made with 20 days of the intervention.

Conditions

  • Difficulties, Ambulation
  • Brain Injuries, Traumatic

Interventions

BEHAVIORAL

Intensive Mobility Training (IMT)

Intensive Mobility Training will be used as an intensive physical therapy intervention. Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED
  • INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

    lead OTHER

Principal Investigators

  • Stacy Fritz, Ph.D., P.T. · University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418976 on ClinicalTrials.gov