Evaluation of the Pedal-Controlled Surgistep Platform to Improve Ergonomics

August 22, 2025 updated by: Atman Desai, Stanford University

A Prospective Crossover Study Evaluating the Pedal-Controlled Surgistep Platform to Improve Ergonomics in Neurosurgical Operations

Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

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 Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Health Care

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Regularly perform neurosurgical procedures (cranial/spine)
  • Willing to use both devices (multiple times each).

Exclusion Criteria:

  • Severe MSK conditions preventing device usage
  • Inability/refusal to participate in observation or surveys.

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: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SurgiStep Platform
The surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks.
Device: SurgiStep Platform
The Surgistep (pedal-controlled, adjustable platform) allows real-time height adjustment during surgery. The surgeons can adjust the height of the platform.
Device: Standard Foot stool
Foot stool is considered as the standard of care during surgery.
Placebo Comparator: Standard surgical practice
The surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks.
Device: SurgiStep Platform
The Surgistep (pedal-controlled, adjustable platform) allows real-time height adjustment during surgery. The surgeons can adjust the height of the platform.
Device: Standard Foot stool
Foot stool is considered as the standard of care during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid Entire Body Assessment (REBA) Scale Score
Time Frame: During the surgery upto 60 minutes
The REBA (Rapid Entire Body Assessment) score, used to assess the risk of musculoskeletal disorders (MSDs) in work tasks, ranges from 1 to 15. A lower REBA score indicates a lower risk, with scores below 4 considered to have minimal risk. Higher scores indicate increased risk, with scores of 8 or more indicating a high risk that requires immediate attention and intervention
During the surgery upto 60 minutes
Rapid Upper Limb Assessment (RULA) Scale Score
Time Frame: During the surgery upto 60 minutes
The RULA (Rapid Upper Limb Assessment) scale ranges from 1 to 7, with lower scores indicating lower risk and higher scores indicating higher risk of musculoskeletal disorders.
During the surgery upto 60 minutes

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Atman Desai, MD, Stanford University

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 (Estimated)

August 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Estimated)

August 26, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 80476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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