Improved Training Program for Fall Prevention of War Fighters with Lower Extremity Trauma
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-002999
Sponsor Protocol Number: 16-002999
About this study
This project has three main objectives. First, we will extend our previously successful rehabilitation protocol to a larger set of active-duty service members who have suffered combat-related lower limb trauma. Second, we will assess the extent to which the benefits of improved motor skills conferred by the rehabilitation protocol are retained following training. Third, we will identify, evaluate, and implement existing low cost technologies for measuring trunk control, the training outcome of critical importance, which may be used in lieu of expensive fixed motion capture systems.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Eligible active duty and retired service members and veterans with lower limb trauma (transfemoral amputations, bilateral amputations, and limb salvage), that participated in conventional rehab at the participating military treatment centers.
- For subjects with amputations, residual limb volume must not have fluctuated significantly in the past two months to be considered for inclusion in this study and the individual must be a community ambulator (i.e., K-Level 3 or 4).
- For subjects with limb salvage, they will have an IDEO and have completed the associated training program.
- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
- All subjects must be 18 years of age or older.
Exclusion Criteria:
- Patients with dysvascular disease will be excluded, because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kenton Kaufman, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available