N/A
N=7
Validation of User Needs of the Point Digit With Partial Hand Amputees
Amputation; Traumatic, Hand
Bottom Line
View on ClinicalTrials.gov: NCT04763278 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: VAL-1: System Comfort Validation Test — 100 % of participants who Passed test
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Point Digit (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Point Designs
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAL-1: System Comfort Validation Test |
100 | — |
| PRIMARY VAL-2: Unilateral Function Validation Test |
100 | — |
| PRIMARY VAL-3.1: System Robustness Validation Test With 25 lb Bag |
100 | — |
| PRIMARY VAL-3.2: Robustness Validation Test With Hammer |
100 | — |
| PRIMARY VAL-4: Object Release Validation Test |
100 | — |
| PRIMARY VAL-5: Position Function Validation Test |
100 | — |
| PRIMARY VAL-6: Extension Function Validation Test |
100 | — |
| PRIMARY VAL-7: Grip Functions Validation Test |
100 | — |
| PRIMARY VAL-8: Fine Motor Function Validation Test |
100 | — |
| PRIMARY VAL-9: Overall Function & Robustness Validation Test |
100 | — |
Summary
The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
Eligibility Criteria
Inclusion Criteria
- Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
- Fluent in English
- Individuals aged 18 or greater
Exclusion Criteria
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- Uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation
- Serious uncontrolled medical problems as judged by the project therapist.
Data sourced from ClinicalTrials.gov (NCT04763278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.