Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton

NCT07393971 | Not Yet Recruiting FDA Device

• 2 other identifiers: 0587-25-FB55136
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more efficient. By using information from the person wearing the device, the exoskeleton can quickly find the level of support that works best for them. The long-term goal is to create personalized walking assistance that can help people with mobility limitations move more comfortably and with less effort.

Conditions

Healthy Young Adults

Keywords

robotic ankle exoskeleton; human-in-the-loop optimization; wearable robotics; musculoskeletal modeling; muscle activation analysis

Outcome Measures

Primary Outcomes (1)

• Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller

  Device feasibility will be evaluated by the successful real-time operation of the robotic ankle exoskeleton and adaptive controller during treadmill walking. Feasibility is defined as the controller's ability to continuously generate, update, and apply assistive torque in real time based on incoming biomechanical and physiological data without system failure, interruption, or safety-related termination. Successful operation will be confirmed by continuous controller function and synchronized data acquisition across walking trials.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Net Metabolic Rate During Exoskeleton-Assisted Walking Measured by Indirect Calorimetry

  through study completion, an average of 1 year

• Estimated Metabolic Rate Derived From Joint-Space Musculoskeletal Modeling

  through study completion, an average of 1 year

• Estimated Lower-Limb Muscle Activation Derived From Joint-Space Musculoskeletal Modeling

  through study completion, an average of 1 year

• Lower-Limb Muscle Activation Measured by Surface Electromyography During Walking

  through study completion, an average of 1 year

• During treadmill walking trials conducted at a single study visit

  through study completion, an average of 1 year

Study Arms (1)

Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller

EXPERIMENTAL

This arm employs a within-subject design with two methods of estimating metabolic cost versus the gold standard measure of metabolic cost, wherein a single participant is subjected to two distinct measurements. This design allows for a direct comparison of the effects of each method (i.e., estimation versus gold standard) within the same individual, minimizing intersubject variability and enhancing the statistical power of the analysis.

Device: Adaptive Torque Control System for Ankle Exoskeleton

Interventions

Adaptive Torque Control System for Ankle Exoskeleton DEVICE

This intervention uses a robotic ankle exoskeleton equipped with a real-time adaptive controller that adjusts plantarflexion torque based on each participant's walking mechanics. Unlike standard exoskeleton controllers that use fixed or pre-programmed assistance levels, this system employs human-in-the-loop optimization to continuously update torque magnitude and timing during treadmill walking. The controller integrates metabolic estimations, kinematic data, and musculoskeletal modeling to identify individualized assistance patterns that reduce walking effort and improve muscle activation efficiency. Participants complete multiple walking trials while the controller automatically modifies assistance to determine the optimal personalized settings.

Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• able to walk independently on a treadmill for 10 minutes,
• free of neurological, cardiovascular, pulmonary, or musculoskeletal conditions that limit walking and exercising,
• no current lower extremity pain or injury,
• able to wear an exoskeleton and safety harness, can provide informed consent

You may not qualify if:

• history of neurological disease that affected gait or balance,
• current or recent lower extremity musculoskeletal injury or surgery,
• chronic lower extremity pain during walking,
• inability to participate in moderate-intensity exercise,
• require an assistive device for walking,
• any metabolic or systemic diseases that may be exacerbated by exercise

Sponsors & Collaborators

• University of Nebraska: lead
• Madonna Rehabilitation Hospital: collaborator

Study Sites (1)

Biomechanics Research Building, University of Nebraska at Omaha

Omaha, Nebraska, 68108, United States

Location

Study Officials

• Farah Fallahtafti, PhD

  Department of Biomechanics, University of Nebraska at Omaha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farah Fallahtafi, PhD

CONTACT

4025543075; ffallahtafti@unomaha.edu

Study Design

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

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)