To Evaluate the Clinical Impact of the Point Powered System

Point Designs

Status: Not yet enrolling

Conditions: Amputation; Traumatic, Hand

Treatments: Device: Point Powered partial hand prosthetic system

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07135947

R44NS122687 (U.S. NIH Grant/Contract)

348027

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Current/No Device

No Intervention group

Description:

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.

Point Powered

Experimental group

Description:

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.

Treatment:

Device: Point Powered partial hand prosthetic system