Translation of Robotic Apparel for Alleviating Low Back Pain

Boston University Charles River Campus

Status: Enrolling

Conditions: Low Back Pain

Treatments: Device: Back Exosuit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05736393

6716

4UH3AR076731-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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').

Full description

Low back pain (LBP) has a lifetime prevalence of 80%, with approximately 20% of individuals experiencing recurrent episodes or chronic LBP (cLBP). Unfortunately, the evidence for the effectiveness of most rehabilitative treatment is low. With an economic burden approaching $100-billion in the United States alone, the National Institutes of Health has invested millions of dollars in innovative technologies aiming to improve rehabilitative care for low back injuries. As part of this initiative, the investigator's collaborative network of expert clinicians, engineers, and researchers have developed and tested robotic apparel technology (exosuit) that supplements ergonomic and biomechanical training and can be utilized by clinicians in the treatment of individuals with LBP.

Failed rehabilitation, and thus progression from acute to cLBP, is thought to be caused by maladaptive motor control strategies, muscle hyperactivity, reduced movement variability, and development of fear-avoidance-beliefs. The exosuit technology was designed to reduce exertion, encourage safe, varied movement strategies, and promote recovery through well-timed assistive forces to the trunk and hips during flexion postures and lifting tasks. The proposed project builds on this work through use of the exosuit to augment traditional physical therapy care. In doing so, the investigators will determine whether this technology can enhance rehabilitation after back injuries, interrupt the progression of acute to chronic LBP, encourage non-maladaptive movement strategies, and expedite the timeline of return to prior level of function.

To examine the effects of exosuit augmented physical therapy rehabilitation and reduce disability, the investigators will recruit individuals with LBP who are referred to or receiving physical therapy into a single arm clinical trial. The investigators will evaluate feasibility, safety and usability of the exosuit, as well as changes in pain and disability throughout 6 weeks of rehabilitation and compare outcomes to a historical control group who received usual care. The investigators will also evaluate changes in fear-avoidance beliefs, range of motion, and motor control and compare outcomes between exosuit-augmented and no suit conditions over the 6 weeks. Primary outcomes of feasibility, usability, and safety of using a back exosuit to augment routine physical therapy will be evaluated. Secondary outcomes include the efficacy of using a back exosuit to augment routine physical therapy, measured by comparing changes in self-perceived pain and disability compared to the historical control group. Tertiary outcomes include the identification of interventional phenotypes by determining the relationship between changes in symptoms and changes in biomechanics function through exosuit-augmented physical therapy.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Exosuit Augmented Physical Therapy

Experimental group

Description:

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.

Treatment:

Device: Back Exosuit