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

NCT ID: NCT06501092

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation; Traumatic, Hand Amputation, Congenital

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Current/No Device

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Point Mini

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.

Group Type EXPERIMENTAL

Point Mini

Intervention Type DEVICE

Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets

Interventions

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Point Mini

Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Point Designs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Levin Sliker, PhD

Role: PRINCIPAL_INVESTIGATOR

Point Designs

Locations

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Point Designs

Lafayette, Colorado, United States

Site Status NOT_YET_RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Connolly

Role: CONTACT

720-600-4753

Levin Sliker, PhD

Role: CONTACT

720-600-4753

Facility Contacts

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Rebecca Connolly

Role: primary

720-600-4753

Levin Sliker, PhD

Role: backup

720-600-4753

Colleen Coulter

Role: primary

404-785-5684

Rebecca Connolly

Role: backup

720-600-4753

Other Identifiers

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4R44HD113485-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

445970

Identifier Type: -

Identifier Source: org_study_id

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