To Evaluate the Clinical Impact of the Point Powered System
ConditionAmputation; Traumatic, Hand
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoint Designs
About this trial
The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment. This study will be a single subject crossover design where one group of 10 adult partial hand amputees will be evaluated on several metrics on their existing prosthetic treatment (Treatment 1) and the Point Powered system (Treatment 2) over a period of three months using standard two-site myoelectric control. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.
Eligibility criteria
Qualifiers
Partial unilateral hand loss with at least index and/or middle fingers amputated at the MCP level
Intact thumb with full range of motion
Fluent in English
Age of 18 years or older
Disqualifiers
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
Trial design
Treatments tested in this trial
- Point Powered partial hand prosthetic system
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Point Designs
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Hanger Clinic: Prosthetics & Orthotics
Collaborator
University of Colorado, Denver
Collaborator
Infinite Biomedical Technologies
Collaborator
Source ClinicalTrials.gov