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Rapid Rehabilitation for Lower Limb Injury

N/A
Recruiting
Led By Kenton Kaufman, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For subjects with amputations, must be a community ambulator (i.e., K-Level 3 or 4)
For subjects with limb salvage, need to have an IDEO and be entered into the Return-to-Run training program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a new balance training program can help people with limb injuries walk better by improving how much weight they put on the affected limb.

Who is the study for?
This trial is for active duty service members and retired veterans who are community ambulators with lower limb trauma, including certain amputations or limb salvage. They must be enrolled in conventional rehab at military centers and not have excessive pain or neuromuscular issues that would prevent participation.
What is being tested?
The study tests an advanced balance training program aimed at improving weight-bearing on injured limbs to reduce stumbles and falls. Participants will undergo assessments like the Promis Physical Function Questionnaire and various walking tests to measure progress.
What are the potential side effects?
Since this trial involves physical rehabilitation exercises rather than medication, side effects may include muscle soreness, fatigue, or discomfort from the exertion of the therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk independently in the community despite my amputation.
Select...
I use an IDEO brace and am in the Return-to-Run program after limb salvage surgery.
Select...
I have had an amputation or major injury to my lower limb.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Injured Service MembersExperimental Treatment4 Interventions

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,084 Total Patients Enrolled
Kenton Kaufman, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Advance Balance Perturbation Training Program Clinical Trial Eligibility Overview. Trial Name: NCT05225792 — N/A
Lower Limb Injury Research Study Groups: Injured Service Members
Lower Limb Injury Clinical Trial 2023: Advance Balance Perturbation Training Program Highlights & Side Effects. Trial Name: NCT05225792 — N/A
Advance Balance Perturbation Training Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225792 — N/A
~23 spots leftby Apr 2026
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