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Robotic Movement
Robotic Leg Movements for Spinal Cord Injury
N/A
Recruiting
Research Sponsored by Methodist Rehabilitation Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of session, approximately 2 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare if faster or slower movement of legs on a robotic device impacts blood pressure and ability to tolerate being upright.
Who is the study for?
This trial is for individuals aged 16-70 with recent spinal cord injuries (SCI) who experience low blood pressure when standing, weighing less than 297 lbs with leg lengths of 29" - 39". It's not for those with weight-bearing issues, skin lesions where the device fits, uncontrolled diabetes, severe joint contractures in lower limbs, or increased pain/spasticity during leg movements.
What is being tested?
The study tests if different speeds of robotic leg movements using ErigoPro can help manage orthostatic hypotension—low blood pressure upon standing—in people with subacute SCI. It compares faster cadence to slower cadence to see which better prevents or reduces these drops in blood pressure.
What are the potential side effects?
While specific side effects are not listed for this intervention, potential risks may include discomfort from the device fitting and possible increase in symptoms like dizziness or fainting if the condition worsens during testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to end of session, approximately 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of session, approximately 2 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systolic blood pressure variation
Secondary study objectives
Frequency of discontinuation of a portion of the study or termination of the entire study
Frequency of orthostatic hypotension symptoms
Heart rate variation
Awards & 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: TreatmentExperimental Treatment1 Intervention
Progressive elevation (0 degrees, 25 degrees, 50 degrees, 75 degrees; x2 minutes in each position) while on robotic tilt-stepper at the cadence of 0, 40, and 80 steps/minute.
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Who is running the clinical trial?
Methodist Rehabilitation CenterLead Sponsor
6 Previous Clinical Trials
139 Total Patients Enrolled
Dobrivoje Stokic, MD, DScStudy DirectorMethodist Rehabilitation Center
1 Previous Clinical Trials
7 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have weight-bearing restrictions as noted in your medical records or by your main therapist (for spinal cord injury).You have skin sores that make it difficult to use the tilt-table or robot cuffs.You have uncontrolled diabetes with nerve-related issues.You have severe stiffness in your hip, knee, or ankle joints that cannot be improved.You have experienced noticeable signs of low blood pressure during or outside of therapy sessions, or your primary therapist has noted a drop in blood pressure during therapy sessions.Your spinal cord injury occurred within the last 12 weeks.You weigh less than 297 pounds and have a leg length between 29 and 39 inches.Your blood pressure should be between 80 and 140 mmHg when measured while lying down by the nursing staff within 24 hours before joining the study.Your pain or muscle stiffness gets worse when someone else moves your legs during a physical exam.People between the ages of 16 and 70, who are either healthy or have a spinal cord injury.You have a spinal cord injury from a traumatic or non-traumatic cause, at any level of the spine.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
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