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Recruiting NCT05225792

Rapid Rehabilitation to Treat Lower Extremity Trauma

No phase Interventional Lower Limb Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Promis Physical Function Questionnaire, L Test, Narrowing Beam Walking Test, PEQ-A.
Who it may be relevant to
Registry conditions: Lower Limb Trauma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05225792 · 21-010009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗