Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05225792
Rapid Rehabilitation to Treat Lower Extremity Trauma
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Research participants will be eligible active duty service members and retired veterans.
- Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
- Are enrolled in conventional rehabilitation at the participating military treatment centers.
- Subjects 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.
- For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
- For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.
Exclusion criteria
- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
Treatment and study plan
Promis Physical Function Questionnaire
BehavioralPatient reported physical function outcomes
L Test
BehavioralPerformance based measure assessing general physical function and balance ability.
Narrowing Beam Walking Test
BehavioralSubjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.
PEQ-A
BehavioralSurvey on confidence, stumbles and falls.
Other names: Prosthesis Evaluation Questionnaire - Addendum
Primary outcomes
-
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Time frame: 0, 6 months
Fall incidence change between baseline and 6 months
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Registry information
Official study title
Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 7, 2022
- Registry last updated
- Mar 19, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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