Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

Conditions

• Lower Limb Amputation Below Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• As-prescribed stiffness — DEVICE
  A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).
• Two categories stiffer than the as-prescribed stiffness — DEVICE
  A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories stiffer than the as-prescribed stiffness.
• Two categories less stiff than the as-prescribed stiffness — DEVICE
  A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.

Study Details

The goal of this clinical trial is to identify prosthesis stiffness that optimizes balance control in individuals with below knee amputations. The main question this clinical trial will answer is: • Is there an optimal stiffness that improves balance control for specific ambulatory activities and users? Participants will wear a novel prosthesis assembled with three prosthetic feet with a range of stiffness levels: each individual's clinically-prescribed foot stiffness and ± two stiffness categories. While wearing the study prostheses, participants will perform nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain).

Key Dates

Start date

Dec 19, 2024

Status verified

May 2026

Primary completion

Jul 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Walking on 0% slope at self-selected speed
  All participants will walk on a treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking overground.
• Experimental: Walking on 0% slope at 15% slower than self-selected speed
  All participants will walk on a treadmill, in a straight line, on a 0% slope, at a speed that is 15% slower than their self-selected walking speed determined while walking overground.
• Experimental: Walking on 0% slope at 15% faster than self-selected speed
  All participants will walk on a treadmill, in a straight line, on a 0% slope, at a speed that is 15% faster than their self-selected walking speed determined while walking overground.
• Experimental: Walking up an 8% slope at self-selected speed
  All participants will walk on a treadmill, in a straight line, up an 8% slope, at their self-selected walking speed determined while walking overground up an 8% slope.
• Experimental: Walking down an 8% slope at self-selected speed
  All participants will walk on a treadmill, in a straight line, down an 8% slope, at their self-selected walking speed determined while walking overground up an 8% slope.
• Experimental: Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic side
  All participants will walk on a treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking overground, while carrying a 5 kg load in one hand on their prosthetic side.
• Experimental: Walking on uneven terrain at self-selected speed
  All participants will walk on an uneven terrain treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking on the uneven terrain treadmill.
• Experimental: Walking around a 2-meter diameter circle with the prosthesis on the inside of the circle
  All participants will walk overground while following the outline of a 2-meter diameter circle, at their self-selected walking speed determined while walking around the circle, with their prosthetic limb on the inside of the circle.
• Experimental: Walking around a 2-meter diameter circle with the prosthesis on the outside of the circle
  All participants will walk overground while following the outline of a 2-meter diameter circle, at their self-selected walking speed determined while walking around the circle, with their prosthetic limb on the outside of the circle.

Primary Outcome Measure

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

Central Contacts

• Glenn K Klute, PhD
  206-277-6792
  [email protected]
• Elise Campbell
  206-277-6792
  [email protected]

Locations (1)

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