Speed of Robotic Leg Movements and Orthostatic Hypotension in Subacute SCI

Running, not enrolling · Not applicable

Conditions studied: Spinal Cord Injuries, Orthostatic Hypotension

In brief

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).

Key facts

Study ID

NCT04029974

Run by

Methodist Rehabilitation Center

People needed

35

Starts

2019-08-20

Expected to finish

2026-12-01

Last updated by the study team

2025-05-08

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Reported overt signs/symptoms of OH during and/or outside of therapy sessions or primary therapist reports a drop in blood pressure consistent with OH during therapy sessions (SCI)
• Age 16 - 70 years (Healthy \& SCI)
• Traumatic SCI AIS A - C or non-traumatic SCI, all levels of injury (SCI)
• Time since SCI ≤ 12 weeks (SCI)
• Weight ≤ 297 lb, leg length 29" - 39" (per ErigoPro manual) (Healthy \& SCI)
• Systolic BP >80 mmHg and <140 mmHg in supine measured by nursing staff in the 24 hours prior to recruitment. (Healthy \& SCI)

You may not qualify if…

• Weight bearing precautions per medical record or primary therapist report (SCI)
• Skin lesions preventing fitting on the tilt-table or in robot cuffs (Healthy \& SCI)
• History of uncontrolled diabetes (diabetic autonomic issues) (Healthy \& SCI)
• Increase in pain/spasticity during passive leg movements during a hands-on eligibility assessment (SCI)
• Severe fixed contractures affecting the lower limbs (hip, knee, ankle joints) (SCI)

Where it is running

• Methodist Rehabilitation Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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