Walking and Balance Post-TBI



Status:Completed
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:July 2011
End Date:July 2013
Contact:Stacy Fritz, Ph.D., P.T.
Email:REHABLAB@MAILBOX.SC.EDU
Phone:803-777-6887

Use our guide to learn which trials are right for you!

IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE


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.


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
We found this trial at
1
site
?
mi
from
Columbia, SC
Click here to add this to my saved trials