Speed of Robotic Leg Movements and Orthostatic Hypotension in Subacute SCI

NCT04029974 | Active Not Recruiting FDA Device

• 1 other identifier: MRC_ErigoPro_in_SCI
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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-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).

Conditions

Spinal Cord Injuries; Orthostatic Hypotension

Keywords

Spinal cord injury; Orthostatic hypotension; Verticalization; ErigoPro; Finapres Nova

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure variation

  Systolic blood pressure will be beat-to-beat monitored. At each assigned cadence, systolic blood pressure is compared to 0-degrees elevation.

  From enrollment to end of session, approximately 2 Hours

Secondary Outcomes (3)

• Heart rate variation

  From enrollment to end of session, approximately 2 Hours

• Frequency of orthostatic hypotension symptoms

  From enrollment to end of session, approximately 2 Hours

• Frequency of discontinuation of a portion of the study or termination of the entire study

  From enrollment to end of session, approximately 2 Hours

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Device: ErigoPro

Interventions

ErigoPro DEVICE

Robotic tilt-stepper lower extremity movements at the cadence of 0, 40, and 80 steps/minute.

Treatment

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Methodist Rehabilitation Center: lead

Study Sites (1)

Methodist Rehabilitation Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (17)

• Consensus statement on the definition of orthostatic hypotension, pure autonomic failure, and multiple system atrophy. The Consensus Committee of the American Autonomic Society and the American Academy of Neurology. Neurology. 1996 May;46(5):1470. doi: 10.1212/wnl.46.5.1470. No abstract available.

  PMID: 8628505 BACKGROUND

• Ravensbergen HJ, de Groot S, Post MW, Slootman HJ, van der Woude LH, Claydon VE. Cardiovascular function after spinal cord injury: prevalence and progression of dysfunction during inpatient rehabilitation and 5 years following discharge. Neurorehabil Neural Repair. 2014 Mar-Apr;28(3):219-29. doi: 10.1177/1545968313504542. Epub 2013 Nov 15.

  PMID: 24243916 BACKGROUND

• Sahota IS, Ravensbergen HR, McGrath MS, Claydon VE. Cerebrovascular responses to orthostatic stress after spinal cord injury. J Neurotrauma. 2012 Oct 10;29(15):2446-56. doi: 10.1089/neu.2012.2379. Epub 2012 Sep 20.

  PMID: 22720841 BACKGROUND

• Illman A, Stiller K, Williams M. The prevalence of orthostatic hypotension during physiotherapy treatment in patients with an acute spinal cord injury. Spinal Cord. 2000 Dec;38(12):741-7. doi: 10.1038/sj.sc.3101089.

  PMID: 11175374 BACKGROUND

• Gillis DJ, Wouda M, Hjeltnes N. Non-pharmacological management of orthostatic hypotension after spinal cord injury: a critical review of the literature. Spinal Cord. 2008 Oct;46(10):652-9. doi: 10.1038/sc.2008.48. Epub 2008 Jun 10.

  PMID: 18542098 BACKGROUND

• Sampson EE, Burnham RS, Andrews BJ. Functional electrical stimulation effect on orthostatic hypotension after spinal cord injury. Arch Phys Med Rehabil. 2000 Feb;81(2):139-43. doi: 10.1016/s0003-9993(00)90131-x.

  PMID: 10668765 BACKGROUND

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  PMID: 11322152 BACKGROUND

• Faghri PD, Yount JP, Pesce WJ, Seetharama S, Votto JJ. Circulatory hypokinesis and functional electric stimulation during standing in persons with spinal cord injury. Arch Phys Med Rehabil. 2001 Nov;82(11):1587-95. doi: 10.1053/apmr.2001.25984.

  PMID: 11689980 BACKGROUND

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  PMID: 12501950 BACKGROUND

• Chao CY, Cheing GL. The effects of lower-extremity functional electric stimulation on the orthostatic responses of people with tetraplegia. Arch Phys Med Rehabil. 2005 Jul;86(7):1427-33. doi: 10.1016/j.apmr.2004.12.033.

  PMID: 16003676 BACKGROUND

• Hamzaid NA, Tean LT, Davis GM, Suhaimi A, Hasnan N. Electrical stimulation-evoked contractions blunt orthostatic hypotension in sub-acute spinal cord-injured individuals: two clinical case studies. Spinal Cord. 2015 May;53(5):375-9. doi: 10.1038/sc.2014.187. Epub 2014 Nov 4.

  PMID: 25366533 BACKGROUND

• Chi L, Masani K, Miyatani M, Adam Thrasher T, Wayne Johnston K, Mardimae A, Kessler C, Fisher JA, Popovic MR. Cardiovascular response to functional electrical stimulation and dynamic tilt table therapy to improve orthostatic tolerance. J Electromyogr Kinesiol. 2008 Dec;18(6):900-7. doi: 10.1016/j.jelekin.2008.08.007. Epub 2008 Oct 2.

  PMID: 18835189 BACKGROUND

• Czell D, Schreier R, Rupp R, Eberhard S, Colombo G, Dietz V. Influence of passive leg movements on blood circulation on the tilt table in healthy adults. J Neuroeng Rehabil. 2004 Oct 25;1(1):4. doi: 10.1186/1743-0003-1-4.

  PMID: 15679913 BACKGROUND

• Yoshida T, Masani K, Sayenko DG, Miyatani M, Fisher JA, Popovic MR. Cardiovascular response of individuals with spinal cord injury to dynamic functional electrical stimulation under orthostatic stress. IEEE Trans Neural Syst Rehabil Eng. 2013 Jan;21(1):37-46. doi: 10.1109/TNSRE.2012.2211894. Epub 2012 Aug 9.

  PMID: 22899587 BACKGROUND

• Sarabadani Tafreshi A, Riener R, Klamroth-Marganska V. Distinctive Steady-State Heart Rate and Blood Pressure Responses to Passive Robotic Leg Exercise and Functional Electrical Stimulation during Head-Up Tilt. Front Physiol. 2016 Dec 9;7:612. doi: 10.3389/fphys.2016.00612. eCollection 2016.

  PMID: 28018240 BACKGROUND

• Claydon VE, Krassioukov AV. Orthostatic hypotension and autonomic pathways after spinal cord injury. J Neurotrauma. 2006 Dec;23(12):1713-25. doi: 10.1089/neu.2006.23.1713.

  PMID: 17184183 BACKGROUND

• Currie KD, Wong SC, Warburton DE, Krassioukov AV. Reliability of the sit-up test in individuals with spinal cord injury. J Spinal Cord Med. 2015 Jul;38(4):563-6. doi: 10.1179/2045772315Y.0000000004. Epub 2015 Mar 4.

  PMID: 25738545 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dobrivoje Stokic, MD, DSc

  Methodist Rehabilitation Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject repeated measures design

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 23, 2019
• Study Start: August 20, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)