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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 belowSelect...
I have a spinal cord injury between C1-T10 and can still move somewhat.
Select...
I have a spinal cord injury that is not fully paralyzing, lasting more than a year, between my neck and mid-back.
Select...
I can walk and move my ankles, knees, and hips within normal ranges.
Select...
I am between 18 and 75 years old and can walk with little or no help.
Select...
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
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
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 from 30% to 40% of heart rate reserve.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Walking training
2015
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
988 Previous Clinical Trials
1,091,118 Total Patients Enrolled
Rehabilitation Hospital of IndianaOTHER
12 Previous Clinical Trials
5,469 Total Patients Enrolled
Thomas G HornbyPrincipal InvestigatorIndiana University School of Medicine
3 Previous Clinical Trials
2,180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a spinal cord injury between C1-T10 and can still move somewhat.You have a history of autonomic dysreflexia.You weigh more than 400 pounds.I have a spinal cord injury that is not fully paralyzing, lasting more than a year, between my neck and mid-back.I cannot stand for 10 minutes without feeling dizzy or faint.I am currently receiving physical therapy.I can walk and move my ankles, knees, and hips within normal ranges.I wear a significant brace for my neck or upper back.I am between 18 and 75 years old and can walk with little or no help.I do not have major health issues like unhealed wounds, infections, heart disease, severe bone loss, nerve damage in legs, brain injury, or lung problems that limit my ability to exercise.I have a baclofen pump or had botulinum toxin injections in my legs within the last 3 months.I can walk and move my ankles, knees, and hips within normal ranges.You need a ventilator to help you breathe.I am between 18 and 75 years old and can walk with little or no help.
Research Study Groups:
This trial has the following groups:- Group 1: High Intensity Locomotor Training
- Group 2: Low Intensity Locomotor Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Rehabilitation Hospital of Indiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
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