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Walking and Balance Post-TBI

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ClinicalTrials.gov Identifier: NCT01418976
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Tracking Information
First Submitted Date  ICMJE August 16, 2011
First Posted Date  ICMJE August 17, 2011
Last Update Posted Date April 26, 2013
Study Start Date  ICMJE July 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Feasibility as measured by study completion. [ Time Frame: post-treatment (after 20-day intervention) ]
    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 ]
    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 ]
    Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01418976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Efficacy as measured by improvements in gait and mobility. [ Time Frame: from pre- to post-treatment during 20-day intervention. ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Walking and Balance Post-TBI
Official Title  ICMJE IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Difficulties, Ambulation
  • Brain Injuries, Traumatic
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Intensive Mobility Training (IMT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2013)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2011)
12
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01418976
Other Study ID Numbers  ICMJE INTRuST-Walking and Balance
Pro00007596 ( Other Identifier: University of South Carolina IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Study Sponsor  ICMJE INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators  ICMJE U.S. Army Medical Research and Development Command
Investigators  ICMJE
Principal Investigator: Stacy Fritz, Ph.D., P.T. University of South Carolina
PRS Account INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP