Recruiting

Rapid Rehabilitation

Sponsor:

Mayo Clinic

Code:

NCT05225792

Conditions

Lower Limb Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Promis Physical Function Questionnaire

L Test

Narrowing Beam Walking Test

PEQ-A

Study Details

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.

Conditions

Lower Limb Trauma

Study ID

NCT05225792

Start date

Jan 8, 2024

Status verified date

Mar, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Injured Service Members

Interventions

Promis Physical Function Questionnaire

Patient reported physical function outcomes

L Test

Performance based measure assessing general physical function and balance ability.

Narrowing Beam Walking Test

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

PEQ-A

Survey on confidence, stumbles and falls.

Primary outcome measure

  • Prosthesis Evaluation Questionnaire-Addendum (PEQ-A) [ Time Frame: 0, 6 months ]

Central Contacts and Locations

Central contacts

Christine Huyber, CCRP

(507) 266-0984Huyber.Christine@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Christine Deml

507-266-0984deml.christine@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-19.