Validation of User Needs of the Point Digit With Partial Hand Amputees

Point Designs

Status: Completed

Conditions: Amputation; Traumatic, Hand

Treatments: Device: Point Digit

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04763278

R42HD097827 (U.S. NIH Grant/Contract)

253922

Details and patient eligibility

About

The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees 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: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
• Fluent in English
• Individuals aged 18 or greater

Exclusion criteria

• 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 occupational therapist 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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7 participants in 1 patient group

Prosthesis

Experimental group

Description:

Patient is temporarily fit with Point Digit partial hand prosthetic system

Treatment:

Device: Point Digit