To Evaluate the Clinical Impact of the Point Powered System

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Point Designs
Study ID
NCT07135947
Status
Not Yet Recruiting

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Conditions

  • Amputation; Traumatic, Hand

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Point Powered partial hand prosthetic system — DEVICE
    The Point Powered system includes 1-4 3-joint mechatronic digits, low-profile EMG electrodes, a low-profile controller, and flexible batteries. These components will be integrated into a waterproof and dustproof packaging

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Aug 2025
Primary completion
Mar 1, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Current/No Device
    Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device.
  • Experimental: Point Powered
    Outcome measurements will be performed after the subject has been fit with the Point Powered at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.

Primary Outcome Measure

Assessment of Capacity for Myoelectric Control (ACMC) [ Time Frame: Baseline (pre-fitting) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Denver | Anschutz Medical CampusAuroraColorado80045
Stephen Huddle
[email protected]
303-724-5893
Richard Weir, PhD (PRINCIPAL_INVESTIGATOR)
Point DesignsBroomfieldColorado80020
Rebecca Connolly
[email protected]
720-600-4753
Levin Sliker, PhD (PRINCIPAL_INVESTIGATOR)
Hanger ClinicLafayetteColorado80026
Rebecca Connolly
[email protected]
720-600-4753

Find similar trials in Aurora, CO

By research site
University of Colorado Denver | Anschutz Medical Campus· Aurora, COPoint Designs· Broomfield, COHanger Clinic· Lafayette, CO

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