To Assess the Utility of the Point Mini in a Clinical Take-home Study
2 other identifiers
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Start
First participant enrolled
June 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
June 24, 2025
June 1, 2025
1.1 years
July 5, 2024
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
ABILHAND-Kids
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.
Baseline (pre-fitting)
DISABKIDS
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.
Baseline (pre-fitting)
ABILHAND-Kids
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.
Immediately post-fitting
DISABKIDS
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.
Immediately post-fitting
ABILHAND-Kids
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.
30 days post-fitting
DISABKIDS
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.
30 days post-fitting
ABILHAND-Kids
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.
60 days post-fitting
DISABKIDS
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.
60 days post-fitting
Secondary Outcomes (1)
Weekly Diary Entries
Through study completion, an average of 3 months
Study Arms (2)
Current/No Device
NO INTERVENTIONBaseline 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.
Point Mini
EXPERIMENTALOutcome 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.
Interventions
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Point Designs
Lafayette, Colorado, 80026, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30143, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Levin Sliker, PhD
Point Designs
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2024
First Posted
July 15, 2024
Study Start
June 18, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share