To Assess the Utility of the Point Mini in a Clinical Take-home Study
Point Designs
Summary
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.
Eligibility
- Age range
- 5–15 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level * Intact thumb with full range of motion * Fluent in English * Age between 5 and 15 years Exclusion Criteria: * Patients with a residual limb that is unhealed from the amputation surgery * Unhealed wounds * 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 clinic…
Interventions
- DevicePoint Mini
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Locations (2)
- Point DesignsLafayette, Colorado
- Children's Healthcare of AtlantaAtlanta, Georgia