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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248907
Recruitment Status : Withdrawn (Due to Corona Virus guidelines, we have decided to withdraw the study.)
First Posted : January 30, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Davidson, Loma Linda University

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

Condition or disease Intervention/treatment Phase
Amputation Other: 0 pound tension Other: 2 pound tension Other: 4 pound tension Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Evaluating the Effect of Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System
Actual Study Start Date : January 28, 2020
Actual Primary Completion Date : April 27, 2020
Actual Study Completion Date : April 27, 2020

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248907


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Michael Davidson, MPH Loma Linda University
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Responsible Party: Michael Davidson, Assistant Professor Department of Orthotics and Prothetics, Loma Linda University
ClinicalTrials.gov Identifier: NCT04248907    
Other Study ID Numbers: 5190492
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No