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

NCT ID: NCT04248907

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2020-04-27

Brief Summary

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

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.

Conditions

Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

0 pound tension

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

2 pound tension

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

4 pound tension

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Michael Davidson

Assistant Professor Department of Orthotics and Prothetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Davidson, MPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

5190492

Identifier Type: -

Identifier Source: org_study_id