Rapid Rehabilitation to Treat Lower Extremity Trauma

NCT ID: NCT05225792

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Lower Limb Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Injured Service Members

Group Type EXPERIMENTAL

Promis Physical Function Questionnaire

Intervention Type BEHAVIORAL

Patient reported physical function outcomes

L Test

Intervention Type BEHAVIORAL

Performance based measure assessing general physical function and balance ability.

Narrowing Beam Walking Test

Intervention Type BEHAVIORAL

Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.

PEQ-A

Intervention Type BEHAVIORAL

Survey on confidence, stumbles and falls.

Interventions

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Promis Physical Function Questionnaire

Patient reported physical function outcomes

Intervention Type BEHAVIORAL

L Test

Performance based measure assessing general physical function and balance ability.

Intervention Type BEHAVIORAL

Narrowing Beam Walking Test

Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.

Intervention Type BEHAVIORAL

PEQ-A

Survey on confidence, stumbles and falls.

Intervention Type BEHAVIORAL

Other Intervention Names

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Prosthesis Evaluation Questionnaire - Addendum

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kenton R. Kaufman, PhD, PE

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenton Kaufman, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Huyber, CCRP

Role: CONTACT

(507) 266-0984

Facility Contacts

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Christine Deml

Role: primary

507-266-0984

Other Identifiers

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21-010009

Identifier Type: -

Identifier Source: org_study_id

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