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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2022-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation; Traumatic, Hand

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Prosthesis

Patient is temporarily fit with Point Digit partial hand prosthetic system

Group Type EXPERIMENTAL

Point Digit

Intervention Type DEVICE

The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket

Interventions

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Point Digit

The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No