- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418976
Walking and Balance Post-TBI
April 25, 2013 updated by: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29208
- 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as measured by study completion.
Time Frame: post-treatment (after 20-day intervention)
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Feasibility will be determined by the ratio of participants that complete the intervention.
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post-treatment (after 20-day intervention)
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Feasibility as measured by pain ratings.
Time Frame: during 20-day intervention
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Feasibility will be determined by daily change in pain scores as measured using visual analog scales.
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during 20-day intervention
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Feasibility as measured by fatigue ratings.
Time Frame: during 20-day intervention
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Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.
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during 20-day intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy as measured by improvements in gait and mobility.
Time Frame: from pre- to post-treatment during 20-day intervention.
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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.
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from pre- to post-treatment during 20-day intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stacy Fritz, Ph.D., P.T., University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
August 16, 2011
First Submitted That Met QC Criteria
August 16, 2011
First Posted (Estimate)
August 17, 2011
Study Record Updates
Last Update Posted (Estimate)
April 26, 2013
Last Update Submitted That Met QC Criteria
April 25, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INTRuST-Walking and Balance
- Pro00007596 (Other Identifier: University of South Carolina IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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