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Not yet recruiting NCT07135947

To Evaluate the Clinical Impact of the Point Powered System

No phase Interventional Amputation; Traumatic, Hand

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point Powered partial hand prosthetic system.
Who it may be relevant to
Registry conditions: Amputation; Traumatic, Hand. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Point Powered partial hand prosthetic system
    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

Primary outcome measures

  • Assessment of Capacity for Myoelectric Control (ACMC) [Time frame: Baseline (pre-fitting)]
  • The Southampton Hand Assessment Procedure (SHAP) [Time frame: Baseline (pre-fitting)]
  • PROMIS Social Isolation [Time frame: Baseline (pre-fitting)]
  • PROMIS Ability to Participate [Time frame: Baseline (pre-fitting)]
  • PROMIS Physical Function - Upper Extremity [Time frame: Baseline (pre-fitting)]
  • PROMIS Satisfaction with Social Roles and Activities [Time frame: Baseline (pre-fitting)]
  • Assessment of Capacity for Myoelectric Control (ACMC) [Time frame: Immediately post-fitting]
  • The Southampton Hand Assessment Procedure (SHAP) [Time frame: Immediately post-fitting]
  • PROMIS Social Isolation [Time frame: Immediately post-fitting]
  • PROMIS Ability to Participate [Time frame: Immediately post-fitting]
Secondary outcome measures (4)
  • Mean Prosthesis Wear Duration (MPWD) [Time frame: Through study completion, an average of 3 months]
  • Bilateral magnitude (BM) [Time frame: Through study completion, an average of 3 months]
  • Magnitude ratio (MR) [Time frame: Through study completion, an average of 3 months]
  • Secondary activity duration variables [Time frame: Through study completion, an average of 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Colorado Denver | Anschutz Medical Campus — Aurora
  • Point Designs — Broomfield
  • Hanger Clinic — Lafayette

Identifiers

NCT: NCT07135947 · 348027 · R44NS122687

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗