Translation of Robotic Apparel for Alleviating Low Back Pain

NCT05736393 | Completed DMC FDA Device

• 2 other identifiers: 67164UH3AR076731-02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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').

Conditions

Low Back Pain

Keywords

Low Back Pain; Chronic Pain; Rehabilitation; Exosuit; Clinical Trial

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.

Secondary Outcomes (2)

• Change in Pain measured by Numerical rating scale of pain (worst in last 24 hours)

  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)

  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)

Other Outcomes (19)

• Change in Trunk Biomechanics: peak trunk range of motion

  Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.

• Change in Trunk Biomechanics: peak trunk velocity

  Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.

• Change in Trunk Biomechanics: trunk coordination

  Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.

Study Arms (1)

Exosuit Augmented Physical Therapy

EXPERIMENTAL

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.

Device: Back Exosuit

Interventions

Back Exosuit DEVICE

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.

Exosuit Augmented Physical Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Harvard University: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Boston University Physical Therapy Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (20)

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Related Links

• Data Repository

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Conor Walsh, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Lou N. Awad, PhD,DPT

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm clinical trials with propensity-matched control group.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 21, 2023
• Study Start: March 15, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be made available upon publication of the study. It will remain available thereafter on https://healdata.org.
• Access Criteria: Members of BACPAC can access study data in the HEAL Initiative Data Repository using permalink: https://healdata.org/portal/discovery/HDP00349/

Locations

US (1)