Rapid Rehabilitation to Treat Lower Extremity Trauma
Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
January 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
March 19, 2026
March 1, 2026
3.2 years
December 8, 2021
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Fall incidence change between baseline and 6 months
0, 6 months
Study Arms (1)
Injured Service Members
EXPERIMENTALInterventions
Patient reported physical function outcomes
Performance based measure assessing general physical function and balance ability.
Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.
Survey on confidence, stumbles and falls.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kenton Kaufman, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 8, 2021
First Posted
February 7, 2022
Study Start
January 8, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03