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

Conditions

• Lower Limb Amputation Below Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Fixed stiffness prosthesis — DEVICE
  The participant's clinically prescribed prosthesis whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).
• Automatic stiffness prosthesis — DEVICE
  A novel prosthesis whose user-specific and activity-specific stiffness profile is automatically modulated based on their ambulatory activity.

Study Details

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.

Key Dates

First listed

Aug 28, 2026

Start date

Nov 30, 2026

Status verified

Aug 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Fixed stiffness prosthesis then automatic stiffness prosthesis
  A within-subject crossover experiment will be conducted to determine if differences in balance control (peak-to-peak range of frontal plane whole body angular momentum) exist between two study prostheses. The two study prostheses include (1) the participant's fixed stiffness prosthesis and (2) a novel, automatic stiffness prosthesis. The order in which participants wore the study prostheses was randomized. The study will be conducted over 2 weeks. All participants will walk a defined course (both indoors and outdoors) about a hospital facility. Participants in this group will wear their fixed stiffness prosthesis first and then the automatic stiffness prosthesis.
• Experimental: Automatic stiffness prosthesis then fixed stiffness prosthesis
  A within-subject crossover experiment will be conducted to determine if differences in balance control (peak-to-peak range of frontal plane whole body angular momentum) exist between two study prostheses. The two study prostheses include (1) the participant's fixed stiffness prosthesis and (2) a novel, automatic stiffness prosthesis. The order in which participants wore the study prostheses was randomized. The study will be conducted over 2 weeks. All participants will walk a defined course (both indoors and outdoors) about a hospital facility. Participants in this group will wear the automatic stiffness prosthesis and then their fixed stiffness prosthesis.

Primary Outcome Measure

Peak-to-peak range of the frontal plane whole-body angular momentum [ Time Frame: During study visit (approximately 3 hours) ]

Locations (1)

Find similar trials in Seattle, WA