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Back Exosuit for Back Pain

N/A

Waitlist Available

Research Sponsored by Wyss Institute at Harvard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, months (1-4)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a wearable back exosuit can help reduce strain and fatigue for industrial workers and prevent back injuries.

Who is the study for?

This trial is for full-time workers aged 18-65 who regularly perform tasks involving bending, lifting, or lowering objects and have a back length of over 18 inches. They must speak English, have internet access, and not be pregnant or have certain medical conditions like osteoporosis or recent severe back pain.

What is being tested?

The study tests if wearing a back exosuit at work reduces lower back pain or injury compared to those without it. Participants are randomly assigned to use the exosuit as desired during work hours while completing monthly surveys about their experience and any changes in job performance.

What are the potential side effects?

Potential side effects may include discomfort from wearing the exosuit, skin issues due to sensitivity with the suit material, possible hindrance in movement leading to reduced productivity, or reliance on the device over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, months (1-4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, months (1-4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months (1-4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Level of work-interfering low back pain (changes over time and differences between groups)

Self-reported incidence of low back pain (changes over time and differences between groups)

Workplace reported incidence of a low back injury (differences between groups)

Secondary study objectives

Self-reported intensity of global pain (changes over time and differences between groups)

Self-reported intensity of localized body discomfort (changes over time and differences between groups)

Self-reported perception of physical fatigue and effort (changes over time and differences between groups)

+2 more

Other study objectives

Perceived intervention satisfaction, job productivity, device usability, and device adverse events (changes over time and differences between groups)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExosuitExperimental Treatment1 Intervention

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 II: ControlActive Control1 Intervention

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.

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