Speed of Robotic Leg Movements and Orthostatic Hypotension in Subacute SCI

March 11, 2024 updated by: Methodist Rehabilitation Center

Does the Speed of Robotic Leg Movements During Tilt-table Verticalization Affect Orthostatic Hypotension in Persons With Subacute SCI

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (≥10 mmHg) blood pressure upon transition from lying down to an upright position regardless of the presence or absence of overt symptoms (dizziness, lightheadedness, blurred vision, loss of consciousness).

OH is quite common after a spinal cord injury (SCI), especially with more severe injuries above the T6 level. OH can significantly interfere with activities of daily living and it can also interfere with participation during inpatient rehabilitation. Nearly 75% of acute SCI subjects were found to have OH and ~60% reported symptoms of OH during physical therapy activities, which limited almost 50% of the treatment sessions. Developments in rehabilitation technology have culminated in a device, a robotic tilt-stepper (RTS), e.g., known as the Erigo (Hocoma). In an RTS, the robot moves the legs through a pre-selected range of motion at different speeds to limit blood pooling during verticalization. This can be augmented by patterned functional electrical stimulation (FES), e.g., the ErigoPro.

The proof-of-principle study by the developers of the Erigo showed that passive leg movements can stabilize hemodynamic responses in healthy subjects who exhibited near-syncope when placed at 75-deg. for 30 min. Two earlier studies that examined the effect of passive leg movements on hemodynamic responses in healthy subjects used only one movement speed. Two other studies in chronic SCI (which compared the hemodynamic effects of passive leg movements alone or in combination with FES during a tilt-table verticalization) also used only one movement speed. Chi et al. showed no difference in vital signs between application of passive leg movements, FES, or the combination thereof in comparison to baseline.

Based on the literature review, it appears that no previous study has systematically examined the effects of different speeds of robotic leg movements on hemodynamic responses, which is the simplest and most user-friendly way to use RTS in a busy clinical setting. Moreover, no study recruited the most relevant target population, that is, persons with a subacute SCI who often develop OH when moved from lying down to a sitting or standing position. Therefore, it is the intent of this study to determine whether the speed of leg movement during progressive movement towards an upright position has a meaningful impact on a subjects blood pressure and onset of OH.

To test this hypothesis, healthy subjects and subjects with SCI will be recruited to participate in a one time training session with the ErigoPro. The study will occur in the SCI floor of a large rehab center. The sit-up test will be performed to assess if transitioning from supine to sitting position provokes symptoms/signs of OH. All prescribed medication will be noted and allowed as to not interfere with regular care and to reflect a real clinical practice. Each subject will then be transferred to the Erigo and secured to the device. Once secured to the device, the trial will be initiated and the subject will remain in supine for a resting period of approximately 5 minutes (to allow the subjects cardiovascular system to reach steady state) followed by another 2 minutes with their hemodynamic values continuously monitored by a beat-to-beat monitoring device (the Finapres Nova) which will aid in establishment of baseline hemodynamic thresholds. The assigned cadence (either 0, 40, or 80 steps per minute) will be initiated and the subject will then be progressed through angles of elevation including 0, 25, 50, and 75 degrees, spending approximately 2 minutes in each position with hemodynamic responses continuously monitored. If the subject demonstrates any signs/symptoms of OH or their blood pressure falls below or exceeds the established thresholds for safety or any other significant issues arise, they will be immediately returned to the supine position (0 degrees), the assigned cadence discontinued, and that portion of the trial terminated. If the subject demonstrates a return to baseline hemodynamic values within 5 - 10 minutes and they agree to continuation of the trial, they will be progressed to the next assigned speed. Should they not return to baseline values, the medical team will be contacted and the attending physician consulted. Any signs noted by the investigator or symptoms reported by the patient will be recorded and should a portion of the trial be terminated, the cause will be investigated to determine if it was truly due to OH or another issue. If the subject achieves 75 degrees for 2 minutes with no significant issues, they will be returned to supine followed by the next assigned speed being tested in the same fashion as the previously tested assigned speed.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Methodist Rehabilitation Center
        • Contact:
        • Contact:
          • Dobrivoje Stokic, MD, DSc
          • Phone Number: 601-981-2611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Healthy subjects and subjects with SCI:

Inclusion Criteria:

  1. 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)
  2. Age 16 - 70 years (Healthy & SCI)
  3. Traumatic SCI AIS A - C or non-traumatic SCI, all levels of injury (SCI)
  4. Time since SCI ≤ 12 weeks (SCI)
  5. Weight ≤ 297 lb, leg length 29" - 39" (per ErigoPro manual) (Healthy & SCI)
  6. Systolic BP >80 mmHg and <140 mmHg in supine measured by nursing staff in the 24 hours prior to recruitment. (Healthy & SCI)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
Robotic tilt-stepper lower extremity movements at the cadence of 0, 40, and 80 steps/minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure variation
Time Frame: From enrollment to end of session, approximately 2 Hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variation
Time Frame: From enrollment to end of session, approximately 2 Hours
Heart rate will be beat-to-beat monitored. At each assigned cadence, heart rate is compared to 0-degrees elevation.
From enrollment to end of session, approximately 2 Hours
Frequency of orthostatic hypotension symptoms
Time Frame: From enrollment to end of session, approximately 2 Hours
Subject will be instructed to report subjective symptoms (dizziness, lightheadedness, blurred vision, etc) during each elevation angle for each assigned cadence and will be prompted by open ended questions. The investigator(s) will document any additional signs of symptoms (sweating, loss of consciousness, etc) that may not have been reported by the subject.
From enrollment to end of session, approximately 2 Hours
Frequency of discontinuation of a portion of the study or termination of the entire study
Time Frame: From enrollment to end of session, approximately 2 Hours
Investigator(s) will record the presence or absence of events requiring discontinuation of a portion of the study or termination of the entire study at each elevation angle for each assigned cadence.
From enrollment to end of session, approximately 2 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Rehabilitation Center

Investigators

  • Study Director: Dobrivoje Stokic, MD, DSc, Methodist Rehabilitation Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 12, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC_ErigoPro_in_SCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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