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Behavioural Intervention
Arm and Leg Cycling for Spinal Cord Injury
N/A
Waitlist Available
Led By Jose L Pons, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if motorized cycling can help people with a spinal cord injury improve walking ability. Researchers expect it to help.
Who is the study for?
This trial is for individuals aged 18-75 with an incomplete spinal cord injury (SCI) at least one year post-injury. Participants must be able to walk 10 meters with or without assistive devices and have a walking speed less than 0.8 m/s. They should have upper body strength to cycle for at least 15 minutes. Those with complete paraplegia, progressive neurological diseases, significant other diseases, or contraindications for MRI/TMS are excluded.
What is being tested?
The study tests if motor-assisted cycling involving both arms and legs can improve walking function in people with incomplete SCI. It explores whether this exercise regulates spinal movement patterns enough to restore abilities like walking.
What are the potential side effects?
While the trial does not involve drugs that typically cause side effects, participants may experience fatigue from physical exertion or discomfort associated with the use of cycling equipment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 10-meter walking test (10MWT)
Change in 6-minute walking test (6MWT)
Secondary study objectives
Change in Modified Ashworth Scale (MAS)
Change in balance with the Berg balance scale (BBS)
Change in cadence.
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SCI subjectExperimental Treatment1 Intervention
Subject with SCI
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
17,920 Total Patients Enrolled
Jose L Pons, PhDPrincipal InvestigatorShirley Ryan AbilityL
7 Previous Clinical Trials
436 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have partial paralysis affecting my limbs.My walking speed is slower than 0.8 meters per second.I have complete paralysis from the neck down or waist down.My spinal cord injury is at T12 or lower without upper motor neuron damage.I can walk by myself for 30 feet, even with aids like a cane or brace.I do not have any major health issues that would stop me from participating fully in the study.I have partial paralysis affecting my limbs and/or torso.My neurological condition is getting worse.It has been over a year since my injury.I can use an arm bike for at least 15 minutes without help.I do not have metal implants, seizures, drug use, depression, or am not pregnant.I am unable to understand or sign the consent form for this study.I am between 18 and 75 years old.My spinal cord injury is above the T11 level.
Research Study Groups:
This trial has the following groups:- Group 1: SCI subject
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.