To Validate Point Mini User Needs

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06504667
• Lead Sponsor: Point Designs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Study Start: 2025-03-03
• Primary Completion: 2025-07-03
• Study Completion: 2025-07-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prosthesis	Point Mini	Patient is temporarily fit with Point Mini finger prosthetic system

Primary Outcome Measures

Name	Time	Method
VAL-3.1	Day 1 (10 minutes)	User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)
VAL-5	Day 1 (10 minutes)	User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)
VAL-6	Day 1 (10 minutes)	User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)
VAL-7	Day 1 (10 minutes)	User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)
VAL-8	Day 1 (10 minutes)	User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)
VAL-9	Day 1 (8 hours)	User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)
VAL-2	Day 1 (10 minutes)	User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)
VAL-1	Day 1 (8 hours)	User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)
VAL-4	Day 1 (10 minutes)	User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)
VAL-3.2	Day 1 (10 minutes)	User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)

Trial Locations

Locations (2)

University of Colorado Denver | Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Point Designs; 🇺🇸 Lafayette, Colorado, United States