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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00007596 | Other Identifier | University of South Carolina IRB |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy Fritz, Ph.D., P.T. | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina | Columbia | South Carolina | 29208 | United States |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
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| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |