N/A
N=13
To Assess the Utility of the Point Digit in a Clinical Take-home Study
Amputation; Traumatic, Hand
Bottom Line
View on ClinicalTrials.gov: NCT04755790 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) — 74.6 scores on a scale
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
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) |
91.0 | — |
| PRIMARY Disability of the Arm, Shoulder and Hand (DASH) |
15.5 | — |
| PRIMARY Southampton Hand Assessment Procedure (SHAP) |
75.3 | — |
| PRIMARY EuroQol-5 Dimension (EQ-5D-5L) |
90.1 | — |
| PRIMARY Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) |
91.0 | — |
| PRIMARY Disability of the Arm, Shoulder and Hand (DASH) |
15.5 | — |
| PRIMARY Southampton Hand Assessment Procedure (SHAP) |
75.3 | — |
| PRIMARY EuroQol-5 Dimension (EQ-5D-5L) |
90.1 | — |
| PRIMARY Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) |
91.0 | — |
| PRIMARY Disability of the Arm, Shoulder and Hand (DASH) |
15.5 | — |
| PRIMARY Southampton Hand Assessment Procedure (SHAP) |
75.3 | — |
| PRIMARY EuroQol-5 Dimension (EQ-5D-5L) |
90.1 | — |
| PRIMARY Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) |
91.0 | — |
| PRIMARY Disability of the Arm, Shoulder and Hand (DASH) |
15.5 | — |
| PRIMARY Southampton Hand Assessment Procedure (SHAP) |
75.3 | — |
| PRIMARY EuroQol-5 Dimension (EQ-5D-5L) |
90.1 | — |
Summary
This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.
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 (NCT04755790). 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.