Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System

April 29, 2020 updated by: Michael Davidson, Loma Linda University

Evaluating the Effect of Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System

To assess the effects various distraction values have on the 'slippage' effect of a transtibial pin-lock system

Study Overview

Status

Status

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Withdrawn

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

This experiment will consist of a total of four visits. The testing process will consist of a series of castings, surveys, data collection, and outcome testing that includes both endurance and aerobic exercises while wearing the check sockets of varying tension values. The outcome measures will be performed in the Nichol Hall Motion Capture Lab.

  • The participants will sign consent forms and three casts will be taken on the first visit.
  • The second visit will consist of fitting test socket A, which includes socket adjustments and the dynamic alignment. Once the socket is properly fit on the subject, we will begin their three trials (with two to three minute breaks in between trials) of the Time Up and Go assessment (TUG) followed by the Prosthesis Evaluation Questionnaire (PEQ) survey.
  • Visit three will be comprised of socket B fitting, alignment, and testing. The subjects will proceed with the same procedure as stated in visit two. Following the outcome measures, participants will take the PEQ survey for socket B.
  • Visit four is the final visit of testing and data collection. Socket C will be presented to the subject and they will go through the same dynamic alignment process and outcome testing as the previous visits. Once finished, the subjects will take the final PEQ survey on socket C and receive their compensation.

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

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 Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • K3-K4 level ambulator (Participants assessed as a K3 level are community ambulators, with the ability to tread on low level barriers and ambulate at variable speed. The highest K-level, (K4), is for high active, athletic ambulators with the ability or potential to ambulate at high impact, stress, or energy levels.)
  • 18 years or older
  • unilateral trans-tibial amputees with intact skin
  • must have worn their prosthesis for at least 5 months

Exclusion Criteria:

  • patients requiring a custom liner
  • those on dialysis or have heart conditions
  • patients requiring an assistive device (Examples of assistive devices would include; canes, walkers, forearm crutches, wheelchairs, hemi walkers, or rollators)

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: Crossover 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: Socket A
To eliminate variables while casting the student investigators will be using a system very similar to that of Ossur's ICEX, developed in Reykjavik, Iceland. The ICEX system uses an air bladder system that allows a socket to be constructed directly onto the residuum; resulting in even pressure distribution during the time of casting. The ICEX system will ensure that the student investigators are obtaining consistent socket pressures and that the team will be precisely testing the distraction values on the multiple sockets obtained in this experiment. During this experiment, the researchers will be using a modified air bladder system.
Other: 0 pound tension
A digital fish scale will be attached to the distal strap of a gel liner to measure the distraction values while casting. A digital fish scale can measure in pounds or kilograms depending on how you set it. The digital fish scale will be held in place while casting to maintain a consistent tension between the scale and the residual limb.
Active Comparator: Socket B
To eliminate variables while casting the student investigators will be using a system very similar to that of Ossur's ICEX, developed in Reykjavik, Iceland. The ICEX system uses an air bladder system that allows a socket to be constructed directly onto the residuum; resulting in even pressure distribution during the time of casting. The ICEX system will ensure that the student investigators are obtaining consistent socket pressures and that the team will be precisely testing the distraction values on the multiple sockets obtained in this experiment. During this experiment, the researchers will be using a modified air bladder system.
Other: 2 pound tension
A digital fish scale will be attached to the distal strap of a gel liner to measure the distraction values while casting. A digital fish scale can measure in pounds or kilograms depending on how you set it. The digital fish scale will be held in place while casting to maintain a consistent tension between the scale and the residual limb.
Active Comparator: Socket C
To eliminate variables while casting the student investigators will be using a system very similar to that of Ossur's ICEX, developed in Reykjavik, Iceland. The ICEX system uses an air bladder system that allows a socket to be constructed directly onto the residuum; resulting in even pressure distribution during the time of casting. The ICEX system will ensure that the student investigators are obtaining consistent socket pressures and that the team will be precisely testing the distraction values on the multiple sockets obtained in this experiment. During this experiment, the researchers will be using a modified air bladder system.
Other: 4 pound tension
A digital fish scale will be attached to the distal strap of a gel liner to measure the distraction values while casting. A digital fish scale can measure in pounds or kilograms depending on how you set it. The digital fish scale will be held in place while casting to maintain a consistent tension between the scale and the residual limb.

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
Timed Up and Go Test
Time Frame: change between visit 1(baseline/start of study) and visit 2 (about 1 week fter visit 1)
This assessment requires a standard armchair, a stopwatch, and a walkway clearly marked at 10 feet. The participant will be instructed to begin to walk on the word "Go". Promptly, the participant will stand up from the armchair, walk to the line on the floor at a normal pace, turn, then walk back to chair at their selected pace, and sit down again. Due to the fact that the participant will have to do this task three time they will be given a two to three minute resting period in between trials.
change between visit 1(baseline/start of study) and visit 2 (about 1 week fter visit 1)

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
Timed Up and Go Test
Time Frame: change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)
This assessment requires a standard armchair, a stopwatch, and a walkway clearly marked at 10 feet. The participant will be instructed to begin to walk on the word "Go". Promptly, the participant will stand up from the armchair, walk to the line on the floor at a normal pace, turn, then walk back to chair at their selected pace, and sit down again. Due to the fact that the participant will have to do this task three time they will be given a two to three minute resting period in between trials.
change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)
Prosthesis Evaluation Questionnaire
Time Frame: change between visit 1(baseline/start of study) and visit 2 (about 1 week after visit 1)
This questionnaire asks questions regarding the participant's socket, specific bodily sensations, pain in the residual limb, as well as social and emotional aspects of using a prosthesis.
change between visit 1(baseline/start of study) and visit 2 (about 1 week after visit 1)
Prosthesis Evaluation Questionnaire
Time Frame: change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)
This questionnaire asks questions regarding the participant's socket, specific bodily sensations, pain in the residual limb, as well as social and emotional aspects of using a prosthesis.
change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)

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.
Loma Linda University

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: Michael Davidson, MPH, Loma Linda 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.
January 28, 2020

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.
April 27, 2020

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.
April 27, 2020

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).
January 29, 2020

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.
January 29, 2020

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.
January 30, 2020

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.
May 1, 2020

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.
April 29, 2020

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.
April 1, 2020

More Information

Terms related to this study

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.
  • 5190492

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.

Clinical Trials on Amputation

Clinical Trials on 0 pound tension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings