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NCT Number: NCT06501092

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

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.

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Key information

Conditions

Amputation; Traumatic, Hand Amputation, Congenital

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Point Designs, Lafayette, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral or bilateral partial hand limb differences
  • Fluent in English or Spanish
  • Ability to follow simple directions
  • Age between 3 and 17 years

Exclusion criteria

  • Patients with any unhealed wounds on their residual limb(s)
  • Significant cognitive deficits as determined upon clinical evaluation
  • Inability to follow simple directions
  • Significant physical deficits including pain and scarring impacting the design and fitting of the Point Mini prosthesis
  • Other psychosocial, personal, and medical co-morbidities expressed by the subject, family or study personnel

Treatment and study plan

Point Mini

Device

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

Primary outcomes

  1. Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2)

    Time frame: Baseline (pre-fitting), 60 days post-fitting

    The PUFI-2 is a measure of manual ability for children with upper limb impairment with and without a prosthesis. PUFI-2 consists of a questionnaire listing 23-27 manual activities and asks how the child performs the activity, how difficult it is to complete, and whether the prosthesis is useful or not. Both self-report and parent proxy-report versions are available.

  2. PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE)

    Time frame: Baseline (pre-fitting), 60 days post-fitting

    The PROMIS Ped - UE is a questionnaire that measures upper extremity physical function specifically in children. Both self-report and parent proxy-report versions are available.

Secondary outcomes

  1. Weekly Diary Entries

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Levin Sliker, PhD

CONTACT

[email protected]

720-600-4753

Rebecca Connolly

CONTACT

[email protected]

720-600-4753

Sponsors and collaborators

Lead sponsor

Point Designs

Industry

Collaborators

  • Children's Healthcare of Atlanta
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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