To Validate Point Mini User Needs

Point Designs

Status: Enrolling

Conditions: Amputation, Congenital; Amputation; Traumatic, Hand

Treatments: Device: Point Mini

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06504667

445969

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

Details and patient eligibility

About

The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

Enrollment: 5 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 fingers loss at the MCP level
• Intact thumb with full range of motion
• Fluent in English
• Between the ages of 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: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Prosthesis

Experimental group

Description:

Patient is temporarily fit with Point Mini finger prosthetic system

Treatment:

Device: Point Mini