Status:
ACTIVE_NOT_RECRUITING
Speed of Robotic Leg Movements and Orthostatic Hypotension in Subacute SCI
Lead Sponsor:
Methodist Rehabilitation Center
Conditions:
Spinal Cord Injuries
Orthostatic Hypotension
Eligibility:
All Genders
16-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
Orthostatic hypotension (OH) refers to a drop in blood pressure as a result of sitting up or standing up (moving against gravity). OH has been defined as a decrease in systolic (≥20 mmHg) or diastolic...
Eligibility Criteria
Inclusion
- Healthy subjects and subjects with SCI:
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04029974
Start Date
August 20 2019
End Date
December 1 2026
Last Update
May 8 2025
Active Locations (1)
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1
Methodist Rehabilitation Center
Jackson, Mississippi, United States, 39216