Translation of Robotic Apparel for Alleviating Low Back Pain

Description

This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study investigates the effect(s) of augmenting physical therapy (PT) interventions with the use of an experimental wearable soft robotic device ('exosuit').

Conditions

Low Back Pain

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Study Overview

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Study Details

Study overview

This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study investigates the effect(s) of augmenting physical therapy (PT) interventions with the use of an experimental wearable soft robotic device ('exosuit').

Translation of Robotic Apparel for Alleviating Low Back Pain: Back Pain Consortium (BACPAC)

Translation of Robotic Apparel for Alleviating Low Back Pain

Condition
Low Back Pain
Intervention / Treatment

-

Contacts and Locations

Boston

Boston University Physical Therapy Center, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18-70
  • * Diagnosis of LBP by licensed medical provider or self-report of lower back pain (initially gathered through partial HIPAA waiver, and confirmed during in-person screening visit)
  • * Self-reported LBP with bending or lifting
  • * Able to walk without an assistive device.
  • * Willing and able to provide informed consent.
  • * Provide HIPAA Authorization to allow communication with the primary healthcare provider (e.g., treating physical therapist) for communication (as needed) during the study period.
  • * Must undergo physical therapy examination with research physical therapist and be assigned a Treatment-Based Classification (TBC) of movement impairment or control impairment.
  • * Unable to attend all scheduled visits and 1-month phone follow-up
  • * Currently pregnant or likely to become pregnant within 6 weeks
  • * Having received surgery to address current LBP
  • * Having pain or symptoms below the knee that seems related to their current LBP
  • * Having current LBP lasting less than 2 weeks
  • * Diagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.)
  • * Use of a pacemaker or other implanted medical devices
  • * Currently under treatment for cancer
  • * Skin issues / sensitivity that an exosuit could exacerbate (e.g., Epidermolysis Bullosa)
  • * Any other medical conditions that would preclude safe use of the exosuit device as determined by a physical therapist

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston University Charles River Campus,

Conor Walsh, PhD, PRINCIPAL_INVESTIGATOR, Harvard University

Lou N. Awad, PhD,DPT, PRINCIPAL_INVESTIGATOR, Boston University

Study Record Dates

2024-10-30