To Assess the Utility of the Point Mini in a Clinical Take-home Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorPoint Designs
About this trial
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 criteria
Qualifiers
Unilateral or bilateral partial hand limb differences
Fluent in English or Spanish
Ability to follow simple directions
Age between 3 and 17 years
Disqualifiers
Patients with any unhealed wounds on their residual limb(s)
Significant cognitive deficits as determined upon clinical evaluation
Inability to follow simple directions
Significant physical deficits including pain and scarring impacting the design and fitting of the Point Mini prosthesis
Trial design
Treatments tested in this trial
- Point Mini
Treatment groups
14 Participants
are divided into 2 treatment groupsSponsors and collaborators
Point Designs
Lead sponsor
Children's Healthcare of Atlanta
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov