Limb Health and Socket Pressure in Response to Powered Ankle Protheses (OPORP)

November 19, 2025 updated by: Dr. Sashwati Roy, Indiana University

Limb Health and Socket Pressure in Response to Powered Ankle Prostheses

this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Some estimates suggest that by 2050, as many as 3.6 million people in the United States will be living with limb loss, and at least 60% of them will have had at least a foot removed For military personnel, combat-related amputations remain one of the most common major disabling war-related injuries from modern armed conflict. Technological advancements in active prosthetic devices for individuals with transtibial amputation offer the potential for superior function in key areas that could lead to higher rates of RTD and improved quality of life. Currently intended primarily for individuals with a K-level of 3 or 4, active transtibial prostheses that provide controlled plantar/dorsiflexion in either swing (microprocessor-controlled prostheses) or late stance (prostheses with powered propulsion) are likely to become the gold standard in the future as technology continues to improve Indeed, users of these types of prostheses have higher mobility than those using any of the other four categories of prosthetic ankle-foot mechanisms for unlimited community ambulators. Note that a major insurer has recently declared microprocessor-controlled ankle-foot prostheses medically necessary for members whose functional level is 3 or above.The PROPRIO FOOT® by Ossur, is a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. This added ankle control of these devices reduces the risk of falls by increasing toe clearance supports more natural standing posture on slopes and improves stair and slope ascent/descent capability by adapting to the change in terrain. On stairs, the PROPRIO FOOT® has been shown to improve affected leg knee kinematics (increased knee flexion) and kinetics (increased knee moment) instance. These improvements also contributed to higher interlimb symmetry reduced energetic cost of slope ascent and higher Amputee Mobility Predictor with a Prosthesis (AMPPRO) scores . Although the ankle of the PROPRIO FOOT® can be controlled in swing, the device does not have adequate power to provide an active propulsion instance. The Empower ankle by Ottobock is a powered prosthesis that provides active propulsion in late stance to mimic the positive work performed by the ankle plantar flexors in push-off. The Empower has been shown to improve affected leg kinematics (increased ankle range of motion and reduced knee flexion) on smooth flat ground ramp ascent and gravel]. In terms of kinetics, the Empower likewise results in increased ankle power on level ground stairs and ramps . Active prostheses like the PROPRIO FOOT® and Empower ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, perhaps enhancing RTD for military personnel. As with all prosthetic components, though, these active devices are of little use if they induce pain and/or injury at the residual limb to the degree that the user will simply not wear them. The investigators will examine how optimal fit of lower limb prostheses can impact individuals comfort and/or reduce irritation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bryce Hockman, CCRP
  • Phone Number: 3172782715
  • Email: bbhockma@iu.edu

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46228
        • Indiana University Health Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18 and above
  • Weight ≤ 280 lb
  • Ambulate at a K3 level or higher-level determined from patient EHR
  • At least 3 months post-amputation per physician discretion
  • Residual limb length greater than 4.5 inches
  • Use of a passive prosthesis
  • Unilateral transtibial amputees
  • Must be able to ambulate without any assistive devices
  • Subjects must be able to follow directions and give informed consent on their own

Exclusion Criteria:

  • Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
  • Other amputees
  • Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
  • Women who are pregnant or who plan to become pregnant in the near future
  • Individuals diagnosed with renal failure
  • Participants unwilling to wear a cloth face covering for the duration of each visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Proprio Foot
each participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio
Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.
Experimental: Empower foot
ach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio
Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Powered Transtibial Prosthesis on Socket Pressure
Time Frame: 4 weeks
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Skin Perfusion
Time Frame: 4 weeks
Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.
4 weeks
Transepidermal Water Loss (TEWL)
Time Frame: 4 weeks
Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense
University of Notre Dame

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sashwati Roy, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.

IPD Sharing Time Frame

6 months after completion

IPD Sharing Access Criteria

Email study contact

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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