Walking and Balance Post-TBI

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418976
• Other study ID #: INTRuST-Walking and Balance
• Secondary ID: Pro00007596
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: April 25, 2013
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Difficulties, Ambulation

Intervention

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.

Locations

Country	Name	City	State
United States	921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by study completion.	Feasibility will be determined by the ratio of participants that complete the intervention.	post-treatment (after 20-day intervention)	No
Primary	Feasibility as measured by pain ratings.	Feasibility will be determined by daily change in pain scores as measured using visual analog scales.	during 20-day intervention	Yes
Primary	Feasibility as measured by fatigue ratings.	Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.	during 20-day intervention	Yes
Secondary	Efficacy as measured by improvements in gait and mobility.	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.	from pre- to post-treatment during 20-day intervention.	No