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Clinical Trials/NCT05225792
NCT05225792
Recruiting
N/A

Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma

Mayo Clinic1 site in 1 country40 target enrollmentJanuary 8, 2024

Overview

Phase
N/A
Intervention
Promis Physical Function Questionnaire
Conditions
Lower Limb Trauma
Sponsor
Mayo Clinic
Enrollment
40
Locations
1
Primary Endpoint
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2024
End Date
September 30, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenton R. Kaufman, PhD, PE

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Arms & Interventions

Injured Service Members

Intervention: Promis Physical Function Questionnaire

Injured Service Members

Intervention: L Test

Injured Service Members

Intervention: Narrowing Beam Walking Test

Injured Service Members

Intervention: PEQ-A

Outcomes

Primary Outcomes

Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)

Time Frame: 0, 6 months

Fall incidence change between baseline and 6 months

Study Sites (1)

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