Difficulties, AmbulationNCT01418976
Walking and Balance Post-TBI
A study testing Intensive Mobility Training (IMT) in people with Difficulties, Ambulation and Brain Injuries, Traumatic, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficulties, Ambulation, Brain Injuries, Traumatic
- What is being tested?
- Intensive Mobility Training (IMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
- Being tested
- Intensive Mobility Training (IMT)
- Keywords
- physical therapy techniques, brain injuries, traumatic, walking, gait, postural balance
- Medical subject headings
- Mobility Limitation, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Mobility Training (IMT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intensive Mobility Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by study completion.
Feasibility will be determined by the ratio of participants that complete the intervention.
Measured: 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.
Measured: 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.
Measured: during 20-day intervention
Secondary outcomes (1)
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.
Measured: from pre- to post-treatment during 20-day intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficulties, AmbulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Stacy Fritz, Ph.D., P.T., Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418976
- Sponsor's protocol ID
- INTRuST-Walking and Balance
- Other IDs
- Pro00007596
- Status last verified
- Apr 2013
- First submitted
- 16 Aug 2011
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE
- ClinicalTrials.gov ID
- NCT01418976
- Acronym / sponsor ID
- INTRuST-Walking and Balance
- Keywords
- physical therapy techniques, brain injuries, traumatic, walking, gait, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical ConsortiumUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Mobility Training (IMT) | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intensive Mobility Training (IMT) |
Primary outcome
Feasibility as measured by study completion.
Time frame: post-treatment (after 20-day intervention)
Feasibility will be determined by the ratio of participants that complete the intervention.
Feasibility as measured by pain ratings.
Time frame: during 20-day intervention
Feasibility will be determined by daily change in pain scores as measured using visual analog scales.
Feasibility as measured by fatigue ratings.
Time frame: during 20-day intervention
Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.
1 secondary outcome
Efficacy as measured by improvements in gait and mobility.
Time frame: from pre- to post-treatment during 20-day intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Fritz, Ph.D., P.T. principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Mobility Training (IMT) in people with Difficulties, Ambulation and Brain Injuries, Traumatic, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by study completion. (time frame: post-treatment (after 20-day intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.