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Behavioural Intervention

Amplified Gait Training for Spinal Cord Injury (AGILE SCI Trial)

N/A

Waitlist Available

Led By Keith Edward Gordon, 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

Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 week change from baseline, 10 week change from baseline, 3 month change from baseline

Awards & highlights

AGILE SCI Trial Summary

This trial is testing a new way to improve the balance of people with incomplete spinal cord injuries.

Who is the study for?

This trial is for Veterans with spinal cord injuries (SCI) who can walk 10 meters without physical help but may use devices like a cane or ankle braces. They must be medically stable, able to travel to the test site, and have had their injury for over 6 months. People with severe spasticity, knee-crossing braces, inability to stand for 30 minutes, serious heart/lung disease, frequent fractures or other leg issues are excluded.Check my eligibility

What is being tested?

The study tests two ways of gait training: one in a Movement Amplification Environment and another on a treadmill. The goal is to see which method better improves walking balance and mobility in individuals with SCI.See study design

What are the potential side effects?

While specific side effects aren't listed here, gait training could potentially cause muscle soreness, fatigue or increase the risk of falls during sessions due to challenges associated with balance and mobility exercises.

AGILE SCI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My spinal cord injury is between my neck and mid-back, and I have some motor function.

AGILE SCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 week change from baseline, 10 week change from baseline, 3 month change from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 week change from baseline, 10 week change from baseline, 3 month change from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 week change from baseline, 10 week change from baseline, 3 month change from baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Daily Stepping

Lane Width Optimization Test

Secondary outcome measures

10 Meter Walk Test (10MWT)

Activities Specific Balance Confidence (ABC) Scale

Balance Evaluations Systems Test (BESTest)

+11 more

AGILE SCI Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Movement Amplification groupExperimental Treatment1 Intervention

The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.

Group II: Treadmill groupActive Control1 Intervention

Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,417 Total Patients Enrolled

Northwestern UniversityOTHER

1,585 Previous Clinical Trials

917,195 Total Patients Enrolled

Keith Edward Gordon, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL

Media Library

Gait training performed in a Movement Amplification Environment (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04340063 — N/A

Gait training performed in a Movement Amplification Environment (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340063 — N/A

Frequently Asked Questions

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

Is there currently an opportunity to participate in this experiment?

"Affirmative. According to clinicaltrials.gov, this research effort is actively recruiting participants since it was posted on October 15th 2020 and updated on December 8th 2021. A total of 36 individuals are required from 1 hospital location."

Answered by AI

What does this clinical trial seek to accomplish?

"This trial, to be monitored over a 10 Week Change from Baseline and 3 Month Change from Baseline period, aims to evaluate Lane Width Optimization Test. Secondary outcomes are the following: 10 Meter Walk Test (10MWT), The World Health Organization Quality of Life Scale (WHOQOL-BREF) and Biomechanical Assessment - Minimum lateral margin of stability. Respectively defined as an individual's average walking speed assessment; a 26 item self-report quality of life evaluation focusing on physical, psychological, social and environmental health with scores ranging 0-100; quantifying changes in dynamic balance during each step taken while walking via"

Answered by AI

Is it feasible for me to join this research endeavor?

"This medical trial requires 36 participants with spinal cord injuries aged 18 and 75. To qualify, applicants must meet an array of prerequisites: Neurologic level of the SCI between C1-T10 according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D; 6 months since initial injury has elapsed; Passive range of motion in legs functional without hindering locomotor training; Capable of travelling to testing location unaided; Mobility over 10m independent from physical support, though unilateral assistive devices such as single cane/anklefoot orthosis are acceptable."

Answered by AI

Is the trial recruiting elderly participants?

"Stipulated by the eligibility requirements, this clinical trial permits adults aged 18 to 75 years old."

Answered by AI

How many participants is the research team seeking for their project?

"Yes, data posted on clinicaltrials.gov signifies that this research is currently open for enrollment. The trial was first made available on October 15th 2020 and the latest update occurred December 8th 2021. A total of 36 volunteers need to be recruited from one venue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury

2020. "Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340063.

All > Spinal Cord