Point Mini for children with partial hand differences
To Assess the Utility of the Point Mini in a Clinical Take-home Study
NA · Point Designs · NCT06501092
This trial will test whether the Point Mini helps children ages 5–15 with partial hand loss use their hands better than their current prosthesis, other assistive device, or no device.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | Point Designs (industry) |
| Locations | 2 sites (Lafayette, Colorado and 1 other locations) |
| Trial ID | NCT06501092 on ClinicalTrials.gov |
What this trial studies
This interventional single-subject crossover study will enroll 14 children aged 5–15 with partial hand deficiencies. Participants will use their existing prosthetic treatment for one month and then use the Point Mini system for two months while taking the device home. Outcomes include in-clinic functional tests, caregiver- and patient-reported measures, bilateral hand use tracking, and prosthesis wear time. The design compares each child’s performance with their usual device versus the Point Mini to identify within-subject changes.
Who should consider this trial
Good fit: Children aged 5–15 with partial hand loss including at least index and/or middle finger loss at the MCP level and an intact, fully mobile thumb who are fluent in English are ideal candidates.
Not a fit: Children with unhealed residual limbs or wounds, significant cognitive or neurological deficits, uncontrolled pain or phantom pain, serious uncontrolled medical problems, or physical limitations of the residual limb that prevent participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the Point Mini could improve everyday hand function and increase prosthesis wear time for children with partial hand deficiencies.
How similar studies have performed: Prior small studies and case reports of pediatric partial-hand prostheses have shown promising functional gains, but take-home crossover data specifically for the Point Mini is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lafayette, Colorado and 1 other locations
- Point Designs — Lafayette, Colorado, United States (NOT_YET_RECRUITING)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Levin Sliker, PhD — Point Designs
- Study coordinator: Rebecca Connolly
- Email: becca@pointdesigns.com
- Phone: 720-600-4753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, Traumatic, Hand, Amputation, Congenital