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

Not Applicable

Not yet recruiting

• Conditions: Amputation; Traumatic, Hand; Amputation, Congenital
• Interventions: Device: Point Mini

• Registration Number: NCT06501092
• Lead Sponsor: Point Designs

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Study Start: 2025-03-03
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Point Mini	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.

Primary Outcome Measures

Name	Time	Method
ABILHAND-Kids	60 days post-fitting	The ABILHAND-Kids is a measure of manual ability for children with upper limb impairment. ABILHAND-Kids consists of a questionnaire listing 21 manual activities and the child's parents respond with their perception of the child's performance and effort on a 3-point scale.
DISABKIDS	60 days post-fitting	The DISABKIDS questionnaire measures general quality of life and the level of distress caused by the chronic condition. Both self-report and parent proxy-report versions are available. It is suitable for pediatric patients between 4-16 years of age with chronic health conditions.

Secondary Outcome Measures

Name	Time	Method
Weekly Diary Entries	Through study completion, an average of 3 months	Throughout the study, subjects and their parents will fill out weekly logs asking their experiences during the day, number of hours wearing the device, descriptions of the tasks performed, and open-response sections to clarify/detail any other events. The weekly logs will be in sealed envelopes and not opened until the completion of the study by the experimenters.

Trial Locations

Locations (2)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Point Designs; 🇺🇸 Lafayette, Colorado, United States