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

NCT04248907 | Withdrawn

• 1 other identifier: 5190492
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Timed Up and Go Test

  change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)

• Prosthesis Evaluation Questionnaire

  change between visit 1(baseline/start of study) and visit 2 (about 1 week after visit 1)

• Prosthesis Evaluation Questionnaire

  change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)

Study Arms (3)

Socket A

EXPERIMENTAL

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

Socket B

ACTIVE COMPARATOR

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

Socket C

ACTIVE COMPARATOR

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

Interventions

0 pound tension 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 A

2 pound tension 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

4 pound tension 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• years or older
• unilateral trans-tibial amputees with intact skin
• must have worn their prosthesis for at least 5 months

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Study Officials

• Michael Davidson, MPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Orthotics and Prothetics

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 30, 2020
• Study Start: January 28, 2020
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

US (1)