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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.)

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

GEM Trial 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.Check my eligibility

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.See study design

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.

GEM Trial 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.

GEM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Step Length Symmetry

Secondary outcome measures

Free-living daily step count

Six-minute walk test

World Health Organization Disability Assessment Scale 2.0

Other outcome measures

Socket Comfort Score

Transcutaneous oximetry

GEM 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,399 Total Patients Enrolled

Cory L. Christiansen, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO

3 Previous Clinical Trials

223 Total Patients Enrolled

Media Library

Error-augmentation gait training Clinical Trial Eligibility Overview. Trial Name: NCT03995238 — N/A

Below Knee Amputation Research Study Groups: Error-augmentation training, Supervised waking, Error-correction training

Below Knee Amputation Clinical Trial 2023: Error-augmentation gait training Highlights & Side Effects. Trial Name: NCT03995238 — N/A

Error-augmentation gait training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995238 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is senescence a factor when recruiting participants for this trial?

"Based on the requirements of this medical trial, only patients aged 50 to 89 are eligible. Separately, there are 195 studies for minors and 1076 trials specifically targeting adults over 65 years old."

Answered by AI

Are there any vacancies for participants in this trial?

"According to clinicaltrials.gov, this study is open for recruitment and was first advertised on October 9th 2019 before being updated on May 11th 2022."

Answered by AI

Might I qualify for inclusion in this medical experiment?

"This research opportunity is open to 54 individuals, ranging in age from 50 to 89 years old and diagnosed with diabetes mellitus. Additional requirements include unilateral transtibial amputation occurring between 6 months and 10 years prior, a step length asymmetry index greater than 1.0 when walking, and the ability to ambulate without an assistive device on community grounds."

Answered by AI

How many participants have been accepted to take part in this investigation?

"Affirmative, according to the clinicaltrials.gov website this medical study is actively looking for participants and was last updated on May 11th 2022. The trial first posted on October 9th 2019 and requires 54 individuals from 1 specific site."

Answered by AI

Recent research and studies

Physical TherapyJournal

Error-manipulation Gait Training for Veterans with Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol

Kline, Paul W, Noel So, Thomas Fields, Elizabeth Juarez-Colunga, and Cory L Christiansen. 2021. “Error-manipulation Gait Training for Veterans with Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/pzab192.

clinicaltrials.govStudy

Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation

2019. "Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03995238.

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