Rapid Rehabilitation to Treat Lower Extremity Trauma

Not Applicable

Recruiting

• Conditions: Lower Limb Trauma

• Registration Number: NCT05225792
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-07
• Study Start: 2024-01-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-04-01
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)	0, 6 months	Fall incidence change between baseline and 6 months

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States