Health TrialsbyHealthPanel

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

ConditionLower Limb Amputation Below Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSeattle Institute for Biomedical and Clinical Research

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral transtibial (below-knee) amputation

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

Disqualifiers

Presence of disorder, pain, or injury other than amputation that interferes with gait

Current skin irritation or injury on residual limb

Use of an assistive device for walking (cane, walker, etc.)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Walking on 0% slope at self-selected speedExperimental treatment 3 interventions
Group B: Walking on 0% slope at 15% slower than self-selected speedExperimental treatment 3 interventions
Group C: Walking on 0% slope at 15% faster than self-selected speedExperimental treatment 3 interventions
Group D: Walking up an 8% slope at self-selected speedExperimental treatment 3 interventions
Group E: Walking down an 8% slope at self-selected speedExperimental treatment 3 interventions
Group F: Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic sideExperimental treatment 3 interventions
Group G: Walking on uneven terrain at self-selected speedExperimental treatment 3 interventions
Group H: Walking around a 2-meter diameter circle with the prosthesis on the inside of the circleExperimental treatment 3 interventions
Group I: Walking around a 2-meter diameter circle with the prosthesis on the outside of the circleExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Peak-to-peak range of the frontal plane whole-body angular momentum

Frontal plane whole-body angular momentum is a measure of the extent to which a person will rotate in the frontal plane in the absence of an external force or torque. The peak-to-peak range quantifies how much this metric varies and is used to describe a person's balance.

Time frame
During study visit (approximately 3 hours)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seattle Institute for Biomedical and Clinical Research

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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