To Assess the Utility of the Point Mini in a Clinical Take-home Study
NCT Number: NCT06501092
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation; Traumatic, Hand|Amputation, Congenital
Interventions: DEVICE: Point Mini
Sponsor: Point Designs
Collaborators: Children's Healthcare of Atlanta
Sex: ALL
Age: CHILD
Enrollment: 14
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-08-31
Locations: Point Designs, Lafayette, Colorado, 80026, United States|Children's Healthcare of Atlanta, Atlanta, Georgia, 30143, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Weekly Diary Entries, 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., Through study completion, an average of 3 months