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Gait Rehabilitation for Amputation (GEM Trial)

N/A

Recruiting

Led By Cory L. Christiansen, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to ambulate in the community without assistive device

Step length asymmetry during walking (>1.0 asymmetry index.)

Must not have

Unstable heart condition including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis

Active cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation, in hopes of reducing long-term disability.

Who is the study for?

This trial is for older Veterans with diabetes or peripheral artery disease who have had a non-traumatic amputation below the knee. They should be able to walk without help and have had their amputation between 6 months and 10 years ago. Those with traumatic or cancer-related amputations, unstable heart conditions, infections, or active cancer treatment cannot join.

What is being tested?

The study tests two gait training programs designed to improve walking symmetry in Veterans after lower limb loss: error-augmentation and error-correction training, plus supervised walking. It aims to see if these can reduce disability and improve skin health on the remaining limb.

What are the potential side effects?

While not explicitly listed, potential side effects may include muscle soreness, fatigue from exercise, skin irritation at the residual limb due to increased activity during gait training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own without any help from devices.

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My walking step lengths are uneven.

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I have diabetes and/or peripheral artery disease.

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I have had one lower leg amputated due to reasons other than injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an unstable heart condition.

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I am currently receiving treatment for cancer.

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I currently have a serious infection.

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I had an amputation due to injury or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Step Length Symmetry

Secondary study objectives

Free-living daily step count

Six-minute walk test

World Health Organization Disability Assessment Scale 2.0

Other study objectives

Socket Comfort Score

Transcutaneous oximetry

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Error-correction trainingExperimental Treatment1 Intervention

A 4-week, 8 session, treadmill-based gait training program, with error-correction of step asymmetry delivered with an auditory metronome signal while walking on a treadmill. During each training block, the metronome will be set to overcorrect stance time asymmetry through use of asymmetrical metronome tones, 2:1 ratio.

Group II: Error-augmentation trainingExperimental Treatment1 Intervention

A 4-week, 8 session, treadmill-based gait training program, with error-augmentation of step asymmetry delivered on a split-belt treadmill. Each training session will adhere to the same schedule. During the training blocks on the treadmill, the belt under the limb with the shorter step length will be set at 3/4 of the pre-intervention over-ground self-selected walking speed while the belt under the limb with the longer step length will be set to 1/2 of the fast belt speed (2:1 ratio between belts).

Group III: Supervised wakingActive Control1 Intervention

A 4-week, 8 session, treadmill-based supervised walking program. The active comparator group will participate in a supervised treadmill walking program of the same frequency and duration, to the two experimental groups.

0 / 8Eligibility criteria met