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NCT07135947
To Evaluate the Clinical Impact of the Point Powered System
Conditions: Amputation; Traumatic, Hand
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Point Designs
Location: University of Colorado Denver | Anschutz Medical Campus Aurora Colorado
Summary
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
Inclusion Criteria:
* 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
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 clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
* Serious uncontrolled medical problems as judged by the project therapist
Source: ClinicalTrials.gov (NCT07135947). StuddyBuddy aggregates publicly available trial information.