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Due to Corona Virus guidelines, we have decided to withdraw the study.
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To assess the effects various distraction values have on the 'slippage' effect of a transtibial pin-lock system
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Davidson, MPH | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
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| 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. |
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| 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. |
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| 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) |