To Assess the Utility of the Point Mini in a Clinical Take-home Study

Point Designs

Status: Enrolling

Conditions: Amputation, Congenital; Amputation; Traumatic, Hand

Treatments: Device: Point Mini

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06501092

445970

4R44HD113485-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.

Enrollment: 14 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level
• Intact thumb with full range of motion
• Fluent in English
• Age between 5 and 15 years

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: Crossover Assignment

Masking: None (Open label)

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14 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 Mini

Experimental group

Description:

Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.

Treatment:

Device: Point Mini