Status:
COMPLETED
Walking and Balance Post-TBI
Lead Sponsor:
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Difficulties, Ambulation
Brain Injuries, Traumatic
Eligibility:
All Genders
18+ years
Phase:
NA
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 signifi...
Eligibility Criteria
Inclusion
- greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility.
- the ability to follow simple three-step commands;
- the ability to communicate presence and location of pain;
- the ability to sit independently without back or arm support for five minutes;
- the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes;
- the ability to walk 10 meters with maximum 1 person assisting;
- presence of motor deficits (determined by clinical assessment of paresis);
- age ≥ 18;
- ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf
Exclusion
- unable to ambulate 500 feet prior to TBI;
- history of serious chronic obstructive pulmonary disease or oxygen dependence;
- severe weight bearing pain;
- lower-extremity amputation;
- non-healing ulcers on the lower-extremity;
- renal dialysis or end stage liver disease;
- legal blindness or severe visual impairment;
- 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°);
- history of deep venous thrombosis or pulmonary embolism within 6 months
- uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
- severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest;
- intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded);
- history of severe uncontrolled seizure disorder;
- other neurological conditions such as multiple sclerosis or Parkinson's Disease;
- pain that is scored greater than 5 out of 10 on a visual analog scale;
- any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body).
- any other health problems judged by their screening physician to put the client at significant risk of harm during the study
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01418976
Start Date
July 1 2011
End Date
March 1 2013
Last Update
April 26 2013
Active Locations (1)
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1
921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
Columbia, South Carolina, United States, 29208