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Translation of Robotic Apparel for Alleviating Low Back Pain

NCT05736393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

DEVICE

Back Exosuit

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.

Sponsors & Collaborators

  • Harvard University

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Boston University Charles River Campus

    lead OTHER

Principal Investigators

  • Conor Walsh, PhD · Harvard University

  • Lou N. Awad, PhD,DPT · Boston University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-05-10
Completion
2025-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736393 on ClinicalTrials.gov