Clinical trial NCT04248907: Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System
Official title: Evaluating the Effect of Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amputation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Timed Up and Go Test
timeFrame: change between visit 1(baseline/start of study) and visit 2 (about 1 week fter visit 1)
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)
measure: Prosthesis Evaluation Questionnaire
timeFrame: change between visit 1(baseline/start of study) and visit 2 (about 1 week after visit 1)
measure: Prosthesis Evaluation Questionnaire
timeFrame: change between visit 1(baseline/start of study) and visit 3 (about 2 weeks after visit 1)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Michael Davidson, MPH
role: PRINCIPAL_INVESTIGATOR
References: