Robotic Leg Movements for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Methodist Rehabilitation Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This study seeks to evaluate whether the speed (cadence) of lower extremity robotic movement has an impact on orthostatic hypotension and upright tolerance when training with the ErigoPro robotic tilt-stepper. It is hypothesized more frequent short-lasting leg movements (faster cadence) reduces the occurrence/severity of orthostatic hypotension better than less frequent longer-lasting leg movements (slower cadence).

Eligibility Criteria

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.

Inclusion Criteria

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.

+3 more

Exclusion 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.

+2 more

Participant Groups

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.

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.