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Automatic Prosthetic Foot Stiffness Modulation to Improve Balance in the Real World

NCT07791433 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-28

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if automatic stiffness modulation improves balance control in ambulatory individuals with below-knee amputations in real-world conditions. The main question this clinical trial will answer is:

• Can a user-specific automatic stiffness prosthesis improve balance control compared to user's fixed stiffness prosthesis that was clinically prescribed?

Participants will perform free-ranging ambulatory activities outside the laboratory that include nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain) while wearing, in random order, 1) a fixed stiffness prosthesis that was clinically prescribed and 2) an automatic stiffness prosthesis that uses an open source ankle configured to implement a user- and activity-specific automatic stiffness modulation control scheme intended to improve balance control.

Conditions

  • Lower Limb Amputation Below Knee

Interventions

DEVICE

Fixed stiffness prosthesis

The participant's clinically prescribed prosthesis whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).

DEVICE

Automatic stiffness prosthesis

A novel prosthesis whose user-specific and activity-specific stiffness profile is automatically modulated based on their ambulatory activity.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07791433 on ClinicalTrials.gov