Actively Recruiting
Automatic Activity-Dependent and Phase-Varying Prosthetic Foot Stiffness Modulation to Improve Balance Control in Individuals With Lower-Limb Amputations
Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2026-05-13
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how different prosthetic foot stiffness levels affect balance control in individuals with below-knee amputations. The study aims to find the best stiffness that improves balance during various daily walking activities, as people with lower limb amputations face higher fall risks due to lost ankle muscle function. This trial focuses on optimizing prosthesis stiffness to enhance stability and reduce falls. Participants will use a special prosthesis fitted with three different prosthetic feet varying in stiffness: their usual prescribed stiffness, one two levels stiffer, and one two levels less stiff. They will perform nine walking tasks including walking at different speeds on level ground, walking up and down slopes, carrying a load, walking on uneven terrain, and walking in circles with the prosthetic limb inside or outside the circle. These tasks occur on treadmills or overground in a randomized order. During visits lasting about 3 hours, participants will be monitored with motion capture to measure their balance by observing body movement patterns. The main measurement is the peak-to-peak range of whole-body angular momentum in the frontal plane during walking. Researchers will analyze which stiffness level best supports balance for each activity. Rest breaks are provided as needed, and participants will continue using their own sockets adjusted as necessary.
CONDITIONS
Brief Title
Automatic Prosthetic Foot Stiffness Modulation to Improve Balance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transtibial (below-knee) amputation
- Using a prosthesis for at least 6 months
- Wearing the prosthesis for 4 or more hours on average each day
- At least one year post-amputation
- Able to walk on a treadmill
You will not qualify if you...
- Having any disorder, pain, or injury besides the amputation that affects walking
- Current skin irritation or injury on the residual limb
- Using an assistive walking device such as a cane or walker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 visit (approximately 3 hours)
Participants are fit with three different prosthetic feet of varying stiffness levels to test balance control.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108
Actively Recruiting
Research Team
G
Glenn K Klute, PhD
E
Elise Campbell
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
9
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