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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44HD113485-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current/No Device | No Intervention | Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device. | |
| Point Mini | Experimental | Outcome measurements will be performed ~60 days after the subject has been fit with a prosthesis, with additional visits occurring immediately post-fitting and ~30 days post-fitting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point Mini | Device | Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets |
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| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2) | The PUFI-2 is a measure of manual ability for children with upper limb impairment with and without a prosthesis. PUFI-2 consists of a questionnaire listing 23-27 manual activities and asks how the child performs the activity, how difficult it is to complete, and whether the prosthesis is useful or not. Both self-report and parent proxy-report versions are available. | Baseline (pre-fitting), 60 days post-fitting |
| PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE) | The PROMIS Ped - UE is a questionnaire that measures upper extremity physical function specifically in children. Both self-report and parent proxy-report versions are available. | Baseline (pre-fitting), 60 days post-fitting |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Diary Entries | Throughout the study, subjects and their parents will fill out weekly logs asking their experiences during the day, number of hours wearing the device, descriptions of the tasks performed, and open-response sections to clarify/detail any other events. The weekly logs will be in sealed envelopes and not opened until the completion of the study by the experimenters. | Through study completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Connolly | Contact | 720-600-4753 | becca@pointdesigns.com | |
| Levin Sliker, PhD | Contact | 720-600-4753 | levin@pointdesigns.com |
| Name | Affiliation | Role |
|---|---|---|
| Levin Sliker, PhD | Point Designs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Point Designs | Not yet recruiting | Lafayette | Colorado | 80026 | United States |
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| ID | Term |
|---|---|
| C565682 | Amputation, Congenital |
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| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30143 | United States |
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