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Exosuit for Musculoskeletal 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

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.

Do I qualify?Apply below to find out

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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

Media Library

Exosuit Clinical Trial Eligibility Overview. Trial Name: NCT05802914 — N/A

Musculoskeletal Pain Research Study Groups: Control, Exosuit

Musculoskeletal Pain Clinical Trial 2023: Exosuit Highlights & Side Effects. Trial Name: NCT05802914 — N/A

Exosuit 2023 Treatment Timeline for Medical Study. Trial Name: NCT05802914 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications required to take part in this investigation?

"To partake in this research, applicants must present with lower back pain and be between 18-65 years of age. 300 volunteers are required to complete the trial successfully."

Answered by AI

Can individuals who are older than 35 years partake in this research?

"Qualified individuals for this medical research must be between 18 and 65 years of age. Separately, there are eighteen trials available to younger patients as well as 297 studies that seniors can participate in."

Answered by AI

Is there presently any recruitment for this research endeavor?

"The updated information on clinicaltrials.gov reveals that this specific trial is not presently onboarding patients. Originally posted on February 8th 2023, the most recent edit was conducted March 25th of the same year. Although not recruiting now, there are still 371 trials in need of volunteers at this time."

Answered by AI

What objectives is this research endeavor hoping to realize?

"This clinical trial, which will be monitored through Baseline and Months (1-4), aims to evaluate the self-reported incidence of lower back pain across time and between groups. Secondary objectives include measuring workplace reported severity of lowback pain among different patient cohorts using insurance claims for LBI, days off work following a LBI, modified duties after an injury as well as medical payouts associated with such injuries. Additionally, global pains intensity and localized body discomfort at various joints are also being evaluated throughout this study by utilizing Pain Enjoyment Lift General Activity Scale 3 and Cornell MSD Scale respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Soft Active Back Exosuit to Reduce Workplace Back Pain

David Adam Quirk 2023. "Soft Active Back Exosuit to Reduce Workplace Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05802914.

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