COMPLETED

Translation of Robotic Apparel for Alleviating Low Back Pain

Conditions

Low Back Pain Chronic Pain Rehabilitation Exosuit Clinical Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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').

Official Title

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

Quick Facts

Study Start:2024-03-15

Study Completion:2025-05-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05736393

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Conor Walsh, PhD

PRINCIPAL_INVESTIGATOR

Harvard University

Lou N. Awad, PhD,DPT

PRINCIPAL_INVESTIGATOR

Boston University

Study Locations (Sites)

Boston University Physical Therapy Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

Conor Walsh, PhD, PRINCIPAL_INVESTIGATOR, Harvard University
Lou N. Awad, PhD,DPT, PRINCIPAL_INVESTIGATOR, Boston University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-15

Study Completion Date2025-05-10

Study Record Updates

Study Start Date2024-03-15

Study Completion Date2025-05-10

Terms related to this study

Keywords Provided by Researchers

Low Back Pain
Chronic Pain
Rehabilitation
Exosuit
Clinical Trial

Additional Relevant MeSH Terms

Low Back Pain