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High-Intensity Exercise for Spinal Cord Injury

N/A

Recruiting

Led By Thomas G Hornby

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Individuals with motor incomplete SCI (AIS C or D) > 12 mo. duration with anatomical lesions between C1-T10

Individuals with motor incomplete SCI (AIS C or D) > 12 mo. duration will be recruited to participate in the study, with further criteria including anatomical lesions between C1-T10..

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes from baseline to post-testing at 8 weeks

Awards & highlights

Study Summary

This trial aims to compare the effects of high and low-intensity walking exercise in people with spinal cord injury to improve mobility.

Who is the study for?

This trial is for adults aged 18-75 with chronic motor incomplete spinal cord injury (AIS C or D), lasting more than a year, and lesions between C1-T10. They should be able to walk with minimal assistance and have normal range of motion in their legs. Excluded are those over 400 lbs, with certain health issues like unhealed wounds, heart disease, severe osteoporosis, lung diseases, or brain injuries.Check my eligibility

What is being tested?

The study tests the effectiveness of high-intensity walking training versus lower-intensity exercise for people with chronic motor incomplete spinal cord injury. It aims to see which intensity level improves walking ability better.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include muscle soreness, fatigue, joint stress or pain due to intense physical activity involved in the high-intensity walking training.

Eligibility Criteria

Inclusion Criteria

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

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I have a spinal cord injury between C1-T10 and can still move somewhat.

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I have a spinal cord injury that is not fully paralyzing, lasting more than a year, between my neck and mid-back.

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I can walk and move my ankles, knees, and hips within normal ranges.

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I am between 18 and 75 years old and can walk with little or no help.

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I can walk and move my ankles, knees, and hips within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from baseline to post-testing at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes from baseline to post-testing at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline to post-testing at 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Fastest overground walking speed

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Intensity Locomotor TrainingExperimental Treatment1 Intervention

High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates close to 80% of heart rate reserve.

Group II: Low Intensity Locomotor TrainingActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Walking training

2015

Completed Phase 2

~140

0 / 5Eligibility criteria met