Automatic Prosthetic Foot Stiffness Modulation to Improve Balance
NCT ID: NCT06711588
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-12-19
2026-06-30
Brief Summary
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• 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).
Detailed Description
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Each participant will be fit with a novel prosthesis that includes a low-profile prosthetic foot whose stiffness category will be determined by their body weight and activity level (standard clinical practice), a prosthetic foot whose stiffness category is two categories stiffer, and another whose stiffness is two categories less stiff. Participants will continue to use their existing prosthetic socket and suspension system, but their pylon length will be adjusted as needed. While wearing the different study prostheses in randomized order, nine ambulatory activities will be performed motion capture laboratory.
1. Walking on level ground at self-selected speed.
2. Walking on level ground at 15% slower than self-selected speed.
3. Walking on level ground at 15% faster than self-selected speed.
4. Walking up an 8% slope at self-selected speed.
5. Walking down an 8% slope at self-selected speed.
6. Walking on level ground at self-selected speed while carrying a 5 kg load in one hand on their prosthetic side.
7. Walking on level but uneven terrain at self-selected speed.
8. Walking a 2-meter diameter circle at self-selected speed with the prosthetic side on the inside of the circle.
9. Walking a 2-meter diameter circle at self-selected speed with the prosthetic side on the outside of the circle.
Ambulatory activities 1 through 6 will be performed on an instrumented treadmill. The load to be carried in activity 6 will be configured as a grocery bag with handles. Activity 7 will be performed on a rocky terrain treadmill. Activities 8 and 9 will be performed overground across five force plates embedded in the laboratory floor while following the outline of a 2-meter diameter circle. Rest breaks during all activities will be provided as needed.
The data from these experiments will be used to calculate the peak-to-peak range of the frontal plane whole-body angular momentum (a measure of balance control). We hypothesize that an optimal user-specific stiffness profile exists that maximizes balance control (i.e., minimizes the peak-to-peak range of frontal plane whole-body angular momentum over the gait cycle) for each ambulatory activity.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
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.
As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
Interventions
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As-prescribed stiffness
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
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
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.
Eligibility Criteria
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Inclusion Criteria
* Been fit with a prosthesis and used it for at least 6 months
* Wear the prosthesis for 4 or more hours on average per day
* Be at least one-year post-amputation
* Able to walk on a treadmill
Exclusion Criteria
* Current skin irritation or injury on residual limb
* Use of an assistive device for walking (cane, walker, etc.)
18 Years
70 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Seattle Institute for Biomedical and Clinical Research
OTHER
Responsible Party
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Principal Investigators
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Glenn Klute, PhD
Role: PRINCIPAL_INVESTIGATOR
US Department of Veterans Affairs
Richard Neptune, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Locations
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VA Puget Sound Healthcare System
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1817327
Identifier Type: -
Identifier Source: org_study_id