Prosthetic Smart Socket Technology to Improve Patient Interaction, Usability, Comfort, Fit, and Function.

March 18, 2019 updated by: University of South Florida
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces

Study Overview

Status

Status

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

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

Limb loss requires prosthetic use. Prostheses usually consist of 2 components: 1) a soft interface to protect the skin and underlying musculoskeletal tissue and 2) a structural interface to enable attachment of prosthetic components to the human body. The interface connects the patient's body to the prosthetic components and thus ground during gait. The interface has 2 purposes: 1) to distribute weight-bearing forces throughout the entire residual limb (RL) and 2) to suspend the prosthesis during swing phase and unweighting. The interface assists in distributing vertical loads during weight bearing to minimize focal loading on pressure intolerant tissues. The interface also suspends prosthetic components to the RL in swing phase and other periods of unweighting.

Many amputees experience RL complications and decreased mobility resulting from the inability to detect excess pressure or a lack of distal contact with newly fit and poorly fit interfaces. A smart socket technology interface could benefit every new prosthetic patient by prompting the user of a compromised socket fit prior to inhibiting functional use and safety. Further, the smart socket technology interface may ultimately prevent other health complications and improve patient interaction, usability, comfort, fit and function. The ALPS iForce most economically measures these variables more comprehensively than any other known single device. Therefore the smart socket interface technology chosen for this proposal is the ALPs iForce. The iForce tracks pressure over time and indicates to the user when positive or negative distal pressure exists by providing volume management suggestions (i.e. sock-ply adjustments). The user interacts with data measured sent wirelessly to an application on a smart phone (Android/iOS/Windows), handheld device, or PC. Suggestions may include removal or application of prosthetic socks over the RL, or other appropriate volume management strategies, to improve fit and comfort. Early warning to possible skin irritation and breakdown may lead to a healthier limb.

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 (Anticipated)

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.
60

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.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Contact:

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Unilateral transtibial amputation
  2. Unilateral revision or reconstruction of transtibial amputation
  3. Candidate for intermediate stage (i.e. preparatory) socket fitting
  4. Male or female, of any ethnicity
  5. 18-60 yrs of age (i.e. active military age)
  6. 100-275 lbs.

Exclusion Criteria:

  1. Body weight <100 or >275 lbs
  2. Does not speak English or Spanish
  3. Any other level of amputation than unilateral TTA

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Arm 1: Smart socket technology w/patient prompting
The prosthetic user WILL receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). Investigators will have access to the Smart Socket Technology database.
Device: Prosthetic smart socket technology with patient prompting
The smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort.
No Intervention: Arm 2: Clinical protocol. No patient prompting
The prosthetic user WILL NOT receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). However, investigators will have access to the Smart Socket Technology database.

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
Intermediate stage prosthetic complications
Time Frame: Will be tracked for 120 days.
Clinical documentation will track incidence of dermatologic issues, skin breakdown, sock ply, circumference, infection and wound severity.
Will be tracked for 120 days.
Limb volume activity of the residual limb
Time Frame: Will be tracked for 120 days
Limb volume will be tracked through clinical documentation including residual limb volumetrics (circumferential measurements), sock-ply changes (journal), and required interface changes will be used to record volume activity and corresponding consequence and management strategies.
Will be tracked for 120 days
Intermediate stage prosthetic complications (clinical documentation)
Time Frame: Will be tracked for 120 days
Re-hospitalization rate
Will be tracked for 120 days
Intermediate stage prosthetic complications (clinical documentation)
Time Frame: Will be tracked for 120 days
Revision rate will be documented
Will be tracked for 120 days

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
Balance and Stability
Time Frame: 30 days post-amputation and at end of trial (120 days)
Post-amputation balance and stability will be tested with the Amputee Mobility Predictor (AMP). The AMP is a brief physical assessment (≈15min to administer) to objectively determine a lower extremity amputee's functional level. Subjects are assessed by progressing through a hierarchy of mobility tasks including sitting balance, standing balance, obstacle crossing, variable gait speed and stair gait.
30 days post-amputation and at end of trial (120 days)
Mobility
Time Frame: 30 days post-amputation and at end of trial (120 days)

L-Test of Functional Mobility and the 2 minute walk test will be used to assess mobility. The L-Test is practical in design and intended to be used in a standard clinical hallway.29 Subjects begins the test seated in a chair.

The patient rises from the chair, walks three meters, turns 90 degrees and then walks an additional seven meters. Upon completing seven meters, the subject turns 180 degrees, returns, turns 90 degrees to face the chair, and returns the three meters to his chair, where they retake the seat.
30 days post-amputation and at end of trial (120 days)
Step Activity
Time Frame: 120 days
The Smart Socket Technology in this proposal has the capability of measuring step count activity. Step activity monitoring is utilized to count the number of steps taken.
120 days
Step Activity
Time Frame: 120 days
Step activity monitoring is used to count the duration of step bout activity per stepping episode.
120 days

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.
University of South Florida

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.
U.S. Army Medical Research Acquisition Activity

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.
March 29, 2018

Primary Completion (Anticipated)

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.
May 1, 2019

Study Completion (Anticipated)

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 1, 2019

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).
April 4, 2017

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.
June 22, 2017

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.
June 26, 2017

Study Record Updates

Last Update Posted (Actual)

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.
March 20, 2019

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.
March 18, 2019

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.
March 1, 2019

More Information

Terms related to this study

Keywords

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.
  • Pro00026455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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