MedTrace Logo

Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal

NCT07673328 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-06-29

No results posted yet for this study

Summary

The overall goal of this project is to establish a novel design and control paradigm for modular, partial-assist powered orthoses (exoskeletons) to enhance voluntary lower-limb motion and manage pain in broad patient populations. Building upon a previous study period that addressed weakness from advanced age or muscle fatigue, this current period extends the technology to novel powered unloader orthoses designed to manage knee osteoarthritis (OA) pain. The investigators hypothesize that by providing 15-30% of biological joint torque, these motorized devices can reduce muscular contributions to painful loads on the joint's surfaces during activities of daily living (ADLs). The project aims to develop a task-agnostic, neural network-based controller and establish the feasibility of reducing knee pain and muscle effort in individuals with multi-compartment knee osteoarthritis.

Conditions

  • Lower-limb Orthoses
  • Osteoarthritic Knee Pain
  • Osteoarthritis (OA) of the Knee

Interventions

DEVICE

Modular powered orthosis

This study will investigate modular, lower-limb, powered orthoses that fit to user-specific weakened joints and control force/torque in a manner that enhances voluntary motion in broad patient populations. The central hypothesis is that high-torque, low-inertia motor systems controlled with energetic objectives will enable modular powered orthoses to partially assist the joints. High-torque electric motors combined with minimal transmissions can be freely rotated (i.e., backdriven) by human joints, allowing the use of an emerging torque control method called energy shaping to reduce the perceived weight/inertia of the body during any motion. By mounting these modular actuators to commercial orthoses, this technology will be easily prescribed/configured by clinicians.

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • University of Michigan

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2030-03-30
Completion
2030-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07673328 on ClinicalTrials.gov