Rapid Rehabilitation to Treat Lower Extremity Trauma

March 17, 2026 updated by: Kenton R. Kaufman, PhD, PE, Mayo Clinic

Improved Training Method for Advanced Rehabilitation of Warfighters With 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injured Service Members
Behavioral: Promis Physical Function Questionnaire
Patient reported physical function outcomes
Behavioral: L Test
Performance based measure assessing general physical function and balance ability.
Behavioral: Narrowing Beam Walking Test
Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.
Behavioral: PEQ-A
Survey on confidence, stumbles and falls.
Other Names:
  • Prosthesis Evaluation Questionnaire - Addendum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Time Frame: 0, 6 months
Fall incidence change between baseline and 6 months
0, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kenton Kaufman, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-010009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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