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| Name | Class |
|---|---|
| Florida High Tech Corridor Council | OTHER |
| TRS, Inc. | INDUSTRY |
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This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The specific aims of this clinical trial are to:
To evaluate the performance of the prehensors, subjects will complete a randomized A-B crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.) healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or are interested in using a body-powered prosthesis. We anticipate data collection data with 10 non-amputee subject, and 8 amputee subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic hand 1 (Hosmer 5XA) | Active Comparator | This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1 |
|
| Prosthetic hand 2 (TRS Grip 3) | Active Comparator | This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2 |
|
| Non-amputee controls | No Intervention | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hosmer 5XA voluntary opening hook | Device | Voluntary opening prosthetic terminal device ("hand") |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sternal Displacement During Towel Folding Task | Distance sternum is displaced while folding a towel was measured in meters. | Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation. |
| Physical Function Performance 10 Test Score | Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function. | Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation. |
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Inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jason Highsmith, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Voluntary Open Device First Then Voluntary Close Device | Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device) |
| FG001 | Voluntary Close Device First Then Voluntary Open Device | Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device) |
| FG002 | Non-amputee Controls | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. No intervention. Control group.: There are no interventions in this observational arm of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-amputee Control Group | non-amputee healthy controls |
| BG001 | Experimental Group: Unilateral TR or Wrist-disartic Amputees | Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sternal Displacement During Towel Folding Task | Distance sternum is displaced while folding a towel was measured in meters. | Posted | Mean | Standard Deviation | meters | Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voluntary Open (Hosmer 5XA) | This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Highsmith | University of South Florida | 813-974-3806 | mhighsmi@health.usf.edu |
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| TRS Grip 3 voluntary closing hook | Device | Voluntary closing prosthetic terminal device ("hand") |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Non-amputee Controls | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
|
|
| Primary | Physical Function Performance 10 Test Score | Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function. | Posted | Mean | Standard Deviation | units on a scale | Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation. |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Voluntary Close (TRS Grip 3) | This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2 | 0 | 8 | 0 | 8 |
| EG002 | Non-amputee Controls | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. No intervention. Control group.: There are no interventions in this observational arm of the study. | 0 | 10 | 0 | 10 |
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