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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Point Mini
DevicePatient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: Current/No DeviceNo intervention 0 interventions
Group B: Point MiniExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-fitting), 60 days post-fitting2
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.
Time frame
Baseline (pre-fitting), 60 days post-fittingSecondary outcomes
1
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.
Time frame
Through study completion, an average of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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