Soft Active Back Exosuit to Reduce Workplace Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2025-04-26

Brief Summary

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The goal of this clinical trial is to determine if a wearable back exosuit can make it safer and easier for workers who bend, lift, and lower objects in an industrial setting.

Many studies have shown that wearable back exoskeletons or exosuits can provide helpful forces making a person's back muscles work less. It is believed that exosuits can lower a person's level of workplace effort and fatigue, making it less likely for them to have back pain at work. Back exosuits could be a solution to make a job easier, but how well they work in the real-world over a long period of time is unclear.

The investigators want to know if workers who wear a back exosuit during the workday will have lower rates of lower back pain or injury than those who are not wearing a back exosuit. The investigators also want to know how well exosuit technology integrates into the workplace (for example, how this technology improves or hinders job performance).

Participants will be randomized into an exosuit group or control group. Participants in the exosuit group will be given a back exosuit that they can use as much as they want at work. All participants will complete surveys monthly.

Researchers will compare the exosuit group to the control group to see if using a back exosuit in a workplace can reduce a person's risk and impact of low back injury or pain. The investigators also want to see if a back exosuit impacts job productivity and if participants find the exosuit becomes useful or bothersome over time.

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Detailed Description

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Conditions

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Low Back Pain Musculoskeletal Pain Low Back Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into an exosuit or a control group using a 2:1 stratified ratio. Strata will be developed based on workplace, lifetime back pain history, and job tenure (\>90 days). Participants in each group will complete regular workplace tasks while wearing or not wearing a back exosuit respectively.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Because of the transparency of a back exosuit, it is not feasible to blind participants and study team members. However, an independent blind statistician will perform our primary intention to treat analysis on our primary outcome measures. The statistician will perform analysis consistent with our statistical analysis plan, transforming data prior to knowledge of group assignment.

Additional secondary analysis will be performed on open labeled data.

Study Groups

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Exosuit

Exosuit refers to a soft active back exosuit. Participants in the exosuit arm will be fitted to a personal back exosuit device. Participants will be trained on how to use the device (retrieval, donning, powering up, mode switching, and doffing). Participants will be instructed to use the device at work, emphasizing they wear it whenever it seems practical (e.g. lifting) for as long as it remains comfortable. Associates from Verve Motion will check in with exosuit participants to address comfort issues and help participants integrate the exosuit into their workday.

Group Type EXPERIMENTAL

Back Exosuit

Intervention Type DEVICE

The back exosuit is a soft wearable robotic suit designed to improve a wearer physiology, kinetics, kinematics to reduce the possibility of injury. The back exosuit is primarily composed of textiles that wrap around an individual's shoulder (backpack) and thighs (thigh wrap) to serve as anchor points. An actuating element attaches to those anchor elements to provide assistive forces while the user performs a physical activity. The soft wearable robot integrates sensing components to be able to detect user biomechanics and device function and actuating elements via algorithms that command the actuation based on users' intent. To encourage usability, the device is easy to don and intuitive to use. This back exosuit has demonstrated significant reductions in back (18%), hip (11%) and knee (22%) extensor muscle activity during a 1-hour workplace simulation task when compared to lifting without a suit.

Control

Control participants will not be assigned a back exosuit. Participants in the control group will perform workplace tasks as normal, completing study surveys at baseline and monthly for 4 months that are identical to exosuit group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Back Exosuit

The back exosuit is a soft wearable robotic suit designed to improve a wearer physiology, kinetics, kinematics to reduce the possibility of injury. The back exosuit is primarily composed of textiles that wrap around an individual's shoulder (backpack) and thighs (thigh wrap) to serve as anchor points. An actuating element attaches to those anchor elements to provide assistive forces while the user performs a physical activity. The soft wearable robot integrates sensing components to be able to detect user biomechanics and device function and actuating elements via algorithms that command the actuation based on users' intent. To encourage usability, the device is easy to don and intuitive to use. This back exosuit has demonstrated significant reductions in back (18%), hip (11%) and knee (22%) extensor muscle activity during a 1-hour workplace simulation task when compared to lifting without a suit.

Intervention Type DEVICE

Other Intervention Names

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Verve SafeLift Suit

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old
* Works as a full-time (\>35 hours/ week) employee for our Industrial Partner
* Regularly bends, lifts, or lowers objects below hip height \>50% of their working day for multiple periods lasting more than 1 hour without sitting
* Can read and speak in English
* Has internet access
* Has completed an Exosuit Shift Demonstration
* Thigh circumference is \> 19" and \< 32"
* Back length (Neck to Iliac Crest) is \>18"

Exclusion Criteria

* Temporary workers not directly employed by our Industrial Partner
* Diagnosed or self-reported sensory motor disorders (stroke, Parkinson's disease, ALS, multiple sclerosis, spinal cord injury, etc.)
* Use of a pacemaker or other powered, implanted medical devices
* Medical condition that would make the participant likely to break bones (i.e., osteoporosis or osteopenia)
* Spinal fracture in the past 2 years
* Spinal surgery at multiple vertebral levels in the participant's lifetime, including vertebroplasty but excluding injections, such as steroids, nerve blockers, etc.
* Sought medical care for spinal surgery at a single vertebral level in the past 2 years, including vertebroplasty but excluding injections, such as steroids, nerve blockers, etc.
* Current malignant cancer
* Currently pregnant
* Skin issues / sensitivity that an exosuit could exacerbate (e.g., thin skin, sensitive skin, easy rashing, easy bruising or skin conditions, Epidermolysis Bullosa, etc.)
* A current episode of upper back or neck pain, requiring modified duties at work
* A recent episode of LBP resulting in pain (sharp, shooting, burning), radiating below one or both legs (past mid-thigh) in the last 3 months (e.g., sciatica)
* A recent episode of back pain resulting in time off work, modified duties, or seeking medical attention in the last 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes