Translation of Robotic Apparel for Alleviating Low Back Pain

Study Overview
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Brief Summary
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This is a NIAMS-sponsored pilot clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this pilot trial is to preliminary test the impact of a wearable soft robotic exosuit device on pain and disability when used in the physical therapy treatment of individuals with Low Back Pain (LBP). This pilot trial will also determine whether the exosuit improves training capacity within session and through the course of physical therapy care by longitudinally assessing natural and exosuit augmented biomechanics. Ultimately, these results will inform the design of a larger pragmatic clinical trial.

Detailed Description
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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 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 outcome measures of LBP-related disability and pain--i.e., Oswestry Disability Index (ODI) and Pain Enjoyment of Life and General Activity (PEG)-- will be assessed at baseline and every visit of physical therapy care, as well as a 1-month post-discharge. Biomechanics will be assessed with exosuit mounted inertial measurement units at every 3rd visit throughout the plan of care. Other survey-based outcomes will be assessed a baseline, discharge, and 1-month post-discharge.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Back Exosuit


Participation Criteria
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Eligibility Criteria
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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: Must be able to attend all scheduled visits and 1-month phone follow-up Must not be pregnant or likely to become pregnant within 6 weeks Must not have had surgery to address current LBP Must not have radicular symptoms or pain below the buttock Must not have had 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
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm clinical trials with propensity-matched control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exosuit Augmented Physical Therapy<br>Participants will receive 12 sessions of physical therapy care. This care will incorporate evidence-based physical therapy care based on clinical presentation to include manual therapy, therapeutic exercise, and functional therapeutic activities. Between 20-40 minutes of each session will include exosuit use. | Device: Back Exosuit<br>* The device is worn like a backpack. It weighs 6 pounds. Participants will be able to perform movements naturally in the device. A ribbon serves as an external muscle to reduce the load and effort during lifting. As participants bend forward, the device assists the participant by supporting some of their body weight by gently pulling back. As participants stand up, the device assists them by gently pulling their trunk upright. Participants will feel the level of assistance change slightly as they move faster or slower. Participants will use this device during 20-40 minutes of physical therapy exercises during 12 visits over 4-6 weeks. Once it is fit and adjusted to each participant's comfort, the physical therapist will control the level of assistance the device provides similarly to how they would adapt any given exercise. Participants may start with more assistance and wean down over the course of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Pain Intensity and Interference Score | Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from 0 to 10, with higher scores indicating increased pain intensity. | Baseline, Week 6, 1-month post (i.e., 30 days after week 6) | 
| Patient-Reported Disability Score | Patient-reported pain intensity and interference is measured by the Modified Oswestry Disability Questionnaire (MDQ) scale. The MDQ is a series of 10 questions. Results range from 0 to 5, with higher scores indicating increased low-back related disability. | Baseline, Week 6, 1-month post (i.e., 30 days after week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk range of motion | Inertial measurement unit acquired biomechanics of trunk range of motion (degrees) during motion in cardinal planes and overhead squatting. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point. | Baseline, Week 6 | 
| Velocity of trunk motion | Inertial measurement unit acquired biomechanics of trunk velocity of motion (degrees per second) during motion in cardinal planes and overhead squatting. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point. | Baseline, Week 6 | 
| Trunk coordination | Inertial measurement unit acquired biomechanics of trunk coordination during during motion in cardinal planes and overhead squatting. Coordination is characterized by the describing the roundness of the phase portrait between range of motion and velocity. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point. | Baseline, Week 6 | 
| Deadlift peak force | Measured during maximum voluntary isometric contractions (kg) using stationary dynamometer. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point. | Baseline, Week 6 | 
| Trunk endurance | Endurance characterized during isometric standing forward lean with arms crossed (seconds) and legs and back straight. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point. | Baseline, Week 6 | 
| Five Times Sit to Stand | Time (seconds) taken to transfer from sit to stand five times with arms crossed. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point. | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Chronic Pain, Rehabilitation, Exosuit, Clinical Trial