Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Walking and Balance Post-TBI

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01418976
First received: August 16, 2011
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Difficulties, Ambulation
Brain Injuries, Traumatic
Behavioral: Intensive Mobility Training (IMT)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • Feasibility as measured by study completion. [ Time Frame: post-treatment (after 20-day intervention) ] [ Designated as safety issue: No ]
    Feasibility will be determined by the ratio of participants that complete the intervention.

  • Feasibility as measured by pain ratings. [ Time Frame: during 20-day intervention ] [ Designated as safety issue: Yes ]
    Feasibility will be determined by daily change in pain scores as measured using visual analog scales.

  • Feasibility as measured by fatigue ratings. [ Time Frame: during 20-day intervention ] [ Designated as safety issue: Yes ]
    Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.


Secondary Outcome Measures:
  • Efficacy as measured by improvements in gait and mobility. [ Time Frame: from pre- to post-treatment during 20-day intervention. ] [ Designated as safety issue: No ]
    Efficacy will be measured by improvements in mobility and gait as measured by the Dynamic Gait Index, Timed Up and Go, Six- Minute Walk, and Falls Efficacy Scale.


Enrollment: 11
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility.
  2. the ability to follow simple three-step commands;
  3. the ability to communicate presence and location of pain;
  4. the ability to sit independently without back or arm support for five minutes;
  5. the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes;
  6. the ability to walk 10 meters with maximum 1 person assisting;
  7. presence of motor deficits (determined by clinical assessment of paresis);
  8. age ≥ 18;
  9. ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf

Exclusion Criteria:

  1. unable to ambulate 500 feet prior to TBI;
  2. history of serious chronic obstructive pulmonary disease or oxygen dependence;
  3. severe weight bearing pain;
  4. lower-extremity amputation;
  5. non-healing ulcers on the lower-extremity;
  6. renal dialysis or end stage liver disease;
  7. legal blindness or severe visual impairment;
  8. severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°);
  9. history of deep venous thrombosis or pulmonary embolism within 6 months
  10. uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
  11. severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest;
  12. intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded);
  13. history of severe uncontrolled seizure disorder;
  14. other neurological conditions such as multiple sclerosis or Parkinson's Disease;
  15. pain that is scored greater than 5 out of 10 on a visual analog scale;
  16. any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body).
  17. any other health problems judged by their screening physician to put the client at significant risk of harm during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418976

Locations
United States, South Carolina
921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Stacy Fritz, Ph.D., P.T. University of South Carolina
  More Information

No publications provided

Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01418976     History of Changes
Other Study ID Numbers: INTRuST-Walking and Balance, Pro00007596
Study First Received: August 16, 2011
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
physical therapy techniques
brain injuries, traumatic
walking
gait
postural balance

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014