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Back Exosuit for Lower Back Pain

N/A

Recruiting

Led By Lou N. Awad, PhD,DPT

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

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

Must have

Self-reported LBP with bending or lifting

Age 18-70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)

Awards & highlights

Study Summary

This trial tests how a device worn during physical therapy can help reduce Low Back Pain and improve movement. Results will help decide if larger trials should be done.

Who is the study for?

This trial is for individuals aged 18-70 with lower back pain (LBP) that worsens with bending or lifting. Participants must be able to walk unaided, provide consent, and communicate with healthcare providers. They should not be pregnant, have had recent back surgery, experience pain extending below the buttock, suffer from neurological disorders affecting movement control like stroke or Parkinson's disease, use a pacemaker or similar devices, currently undergo cancer treatment, or have skin conditions aggravated by wearing an exosuit.Check my eligibility

What is being tested?

The study tests a wearable soft robotic 'exosuit' designed to alleviate LBP during physical therapy sessions. It aims to see if this high-tech garment can reduce pain and disability and improve patients' ability to train and move. The results will help plan a larger trial on the effectiveness of this innovative approach in treating LBP.See study design

What are the potential side effects?

Since this is a non-drug intervention focusing on a wearable device for physical support during therapy sessions for back pain relief, specific side effects are not listed but may include discomfort while wearing the device or potential skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience lower back pain when I bend or lift.

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I am between 18 and 70 years old.

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I can walk on my own without needing help from devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Biomechanical Suit Effect measured by Trunk range of motion

Change in Biomechanical Suit Effect measured by Trunk velocity

Change in Biomechanical Suit Effect measured by trunk coordination

+9 more

Secondary outcome measures

Change in Pain measured by Numerical rating scale of pain (worst in last 24 hours)

Change in Patient-reported Disability score measured by the modified Oswestry Disability Questionnaire (MDQ)

Other outcome measures

Change in Patient-reported anxiety symptoms: Generalized anxiety disorder 2-item scale (GAD-2)

Change in Patient-reported physical function: Patient specific functional scale (PSFS)

Change in Physical Function: 5x sit to stand

+16 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exosuit Augmented Physical TherapyExperimental Treatment1 Intervention

participants will attend an in person screening, initial visit (1), 10 (2-11) sessions of physical therapy and a discharge visit (12). Participants will undergo a comprehensive biomechanical analysis on visits 1, 3, 6, 9 and 12, completing an extensive battery of surveys at visits 1, discharge, and 1-month post-discharge. Treatment will incorporate evidence-based physical therapy care based on clinical presentation to include manual therapy, therapeutic exercise, and functional therapeutic activities. A portion of each session will include exosuit use.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor

114 Previous Clinical Trials

12,190 Total Patients Enrolled

Harvard UniversityOTHER

230 Previous Clinical Trials

474,525 Total Patients Enrolled

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

484 Previous Clinical Trials

1,086,745 Total Patients Enrolled

Media Library

Exosuit Augmented Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05736393 — N/A

Lower Back Pain Research Study Groups: Exosuit Augmented Physical Therapy

Lower Back Pain Clinical Trial 2023: Exosuit Augmented Physical Therapy Highlights & Side Effects. Trial Name: NCT05736393 — N/A

Exosuit Augmented Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05736393 — N/A

Frequently Asked Questions

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

Are persons aged 40 or above being enrolled in this research study?

"This medical trial seeks patients between 18 and 70 years old. For those younger or older than the specified age range, there are 13 trials for people under 18 and 259 studies open to individuals over 65."

Answered by AI

Is enrollment for this experiment still open?

"Clinicaltrials.gov indicates that enrolment for this medical trial has been completed, as the last update to its information occurred on February 17th 2023. Despite being inactive, there are still 327 active clinical trials available for prospective candidates."

Answered by AI

Can I join this scientific experiment?

"This clinical trial is accepting applications from those aged between 18 and 70 who suffer lower back pain, provided they meet the following criteria: Licensed medical provider's diagnosis or self-reported LBP with bending/lifting; HIPAA Authorization allowing communication with their primary care provider throughout the study duration; physical therapy examination to determine Treatment-Based Classification of movement/control impairment; ambulatory without an assistive device; willingness to provide informed consent."

Answered by AI

What outcomes is this research endeavor hoping to accomplish?

"This medical study seeks to evaluate Patient-Reported Disability Score over Baseline, Week 6 and post 30 days. Secondary objectives include evaluating Velocity of Trunk Motion through Inertial Measurement Unit Biomechanics Acquired during Slack Suit (no exosuit assistance) or Active Suit (exosuit assistance), Trunk Coordination which is characterized by the description of Range of Motion and Velocity, as well as Deadlift Peak Force measured using a stationary dynamometer while donning either slack suit or active suit conditions at each timepoint."

Answered by AI

Recent research and studies

Annals of the Rheumatic DiseasesJournal

The Global Burden of Low Back Pain: Estimates from the Global Burden of Disease 2010 Study

Hoy, Damian, Lyn March, Peter Brooks, Fiona Blyth, Anthony Woolf, Christopher Bain, Gail Williams, et al.. 2014. “The Global Burden of Low Back Pain: Estimates from the Global Burden of Disease 2010 Study”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2013-204428.

clinicaltrials.govStudy

Translation of Robotic Apparel for Alleviating Low Back Pain

2024. "Translation of Robotic Apparel for Alleviating Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05736393.

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