Your session is about to expire
← Back to Search
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)
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 moreOther 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.
Find a Location
Who is running the clinical trial?
Liberty MutualIndustry Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled
Verve MotionUNKNOWN
Wyss Institute at Harvard UniversityLead Sponsor
5 Previous Clinical Trials
133 Total Patients Enrolled
Boston UniversityOTHER
476 Previous Clinical Trials
9,993,240 Total Patients Enrolled
1 Trials studying Low Back Pain
11 Patients Enrolled for Low Back Pain
University of DelawareOTHER
161 Previous Clinical Trials
25,252 Total Patients Enrolled
5 Trials studying Low Back Pain
380 Patients Enrolled for Low Back Pain
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
498 Previous Clinical Trials
1,089,286 Total Patients Enrolled
21 Trials studying Low Back Pain
268,626 Patients Enrolled for Low Back Pain
Industrial PartnerUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spinal fracture within the last 2 years.I am experiencing upper back or neck pain that affects my work.I have been diagnosed with or believe I have a sensory motor disorder like stroke or Parkinson's.I have had spinal surgery at more than one level of my spine, not including injections.I have cancer that is active and spreading.I have a condition like osteoporosis that makes my bones likely to break.I have had lower back pain that spreads to my legs in the last 3 months.I had spinal surgery or vertebroplasty at one level in the last 2 years, but no injections.I've had back pain that affected my work or needed a doctor's visit in the last 3 months.I am between 18 and 65 years old.I frequently bend and lift objects at work for long periods.My thigh circumference is between 19 inches and 32 inches.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Exosuit
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.