Using a robotic exosuit to help relieve low back pain
Translation of Robotic Apparel for Alleviating Low Back Pain: Back Pain Consortium (BACPAC)
This study is testing whether a wearable robotic exosuit can help people with low back pain recover better during physical therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05736393 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a wearable soft robotic device, known as an exosuit, on individuals aged 18-70 suffering from low back pain (LBP). Conducted under the NIH HEAL Initiative, the study aims to augment traditional physical therapy interventions with this innovative technology. The exosuit is designed to reduce exertion and promote safe movement strategies during rehabilitation, potentially enhancing recovery from back injuries. Participants will undergo physical therapy while using the exosuit to assess its effectiveness in improving rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-70 who have been diagnosed with low back pain and can walk without assistive devices.
Not a fit: Patients who have undergone surgery for their current low back pain or have pain symptoms below the knee may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes for patients with low back pain.
How similar studies have performed: Other studies have explored robotic assistance in rehabilitation, showing promising results, but this specific application of an exosuit for low back pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Boston University Physical Therapy Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Conor Walsh, PhD — Harvard University
- Study coordinator: Boston University Physical Therapy Center
- Email: backexo@bu.edu
- Phone: 617-358-3700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.