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').
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
Boston University Physical Therapy Center
Boston, Massachusetts, United States
Change in Suit Usability measured by Quebec User Evaluation of Satisfaction with Assistive technology (QUEST survey 2.0)
Suit usability measured by the QUEST survey 2.0. The QUEST is a standardized usability scale to determine a user's device satisfaction. Results range from 1 to 5 on a Likert Scale, with higher scores (5) corresponding to a very satisfied response.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Suit Safety measured by patient-reported pain
The Numerical Rating Scale of Pain will measure patient-reported levels of current pain intensity at the beginning and end of every study visit. Results range from 0 to 10, with higher scores indicating increased pain intensity.
Time frame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment)
Change in Suit Safety measured by patient reported body discomfort
The patient-reported level of current body discomfort will be appraised using a localized Numerical Rating Scale of Pain. At the end of every study visit, participants will rank their pain level in regions contacted by the exosuit, including the i) shoulders, chest, and upper back, ii) lower back, and iii) the thighs and lower legs. Results range from 0 to 10, with higher scores indicating increased pain intensity.
Time frame: Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment)
Change in Suit Effect & Safety measured by Perceived Task Discomfort
The patient-reported level of task discomfort will be measured at the end of selected biomechanical assessment tasks (performed with the suit in a slack and active condition). Participants will rank task discomfort on a numerical rating scale of task discomfort. Results range from 0 to 10, with higher scores indicating higher total body difficulty.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
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Change in Suit Effect measured by Concern of Movement
Patient-reported level of concern of movement will be measured at the end of each biomechanical visit. Four selected images from the Photo Series of Daily Activity will be ranked, with the participants envisioning themselves completing the task with or without the aid of the exosuit (Quirk et al., 2023). Results range from 0 to 10, with higher scores indicating higher concern with completing the task.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Suit Effect measured by Perceived task effort
Patient-reported level of task effort will be measured at the end of selected biomechanical assessment tasks (performed with the suit in a slack and active condition). Participants will rank task difficulty on a numerical rating scale of task difficulty. Results range from 0 to 10, with higher scores indicating higher task difficulty.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Biomechanical Suit Effect measured by Trunk range of motion
Inertial measurement units (IMUs) are positioned on the torso and each thigh. IMU biomechanics will be processed to determine the peak trunk range of motion. This measure will be calculated in all planes of motion. For selected biomechanical assessment tasks (performed with the suit in a slack and active condition) peak angles and velocity will quantify biomechanical effects.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Biomechanical Suit Effect measured by Trunk velocity
Inertial measurement units (IMUs) are positioned on the torso and each thigh. IMU biomechanics will be processed to determine the peak trunk velocity. This measure will be calculated in all planes of motion. For selected biomechanical assessment tasks (performed with the suit in a slack and active condition) peak angles and velocity will quantify biomechanical effects.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Biomechanical Suit Effect measured by trunk coordination
Inertial measurement units (IMUs) are positioned on the torso and each thigh. IMU biomechanics will be processed to determine the peak trunk velocity. This measure will be calculated in all planes of motion. For selected biomechanical assessment tasks (performed with the suit in a slack and active condition) peak angles and velocity will quantify biomechanical effects.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Functional Suit effect measured by peak deadlift pull force
Measured during maximum voluntary isometric contractions (kg) will be measured using a stationary dynamometer. Peak full force will be measured for the slack and active suit condition.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Functional Suit Effect measured by peak dynamic lifting force
Measured during dynamic 4 repetitions, progressive (5 pound incremental) floor-to-waist functional capacity lifting evaluation. The maximum mass lifted (repetitions performed) will compared between the slack and active suit conditions.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Functional Suit Effect measured by endurance lifting task
Measured during dynamic 2.5 minute dynamic asymmetric lifting task. The maximum repetitions performed will compared between the slack and active suit conditions.
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Change in Pain measured by Numerical rating scale of pain (worst in last 24 hours)
Patient-reported level of their worse pain intensity in the last 24 hours will be measured by the Numerical Rating Scale of Pain, at the beginning and end of every study visit. Results range from 0 to 10, with higher scores indicating increased pain intensity.
Time frame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment), and follow-up post discharge (up to 13 weeks post time 0)
Change in Patient-reported Disability score measured by the modified Oswestry Disability Questionnaire (MDQ)
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.
Time frame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment), and follow-up post discharge (up to 13 weeks post time 0)