Walking and Balance Post-TBI

NCT01418976 | Completed DMC

• 2 other identifiers: INTRuST-Walking and BalancePro00007596
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficulties, Ambulation; Brain Injuries, Traumatic

Keywords

physical therapy techniques; brain injuries, traumatic; walking; gait; postural balance

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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

Secondary Outcomes (1)

• Efficacy as measured by improvements in gait and mobility.

  from pre- to post-treatment during 20-day intervention.

Study Arms (1)

Intensive Mobility Training (IMT)

EXPERIMENTAL

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)

Interventions

Intensive Mobility Training (IMT) BEHAVIORAL

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.

Intensive Mobility Training (IMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Mobility Limitation; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Stacy Fritz, Ph.D., P.T.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

US (1)