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

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• Status: Withdrawn
• Conditions: Amputation
• Intervention / Treatment: Other: 0 pound tension; Other: 2 pound tension; Other: 4 pound tension

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test	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

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test	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	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	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

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Michael Davidson, MPH, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID 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