Congenital Abnormalities Clinical Trial
Official title:
Evaluation of Gamified Training for 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
This will be a prospective study over a 14-month duration with clinical evaluations throughout. Limitless Solutions will provide prosthetics and training system for study subjects that qualify for enrollment.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | November 2027 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | Inclusion Criteria: - Children between the ages of 7 to 17 - Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions. Exclusion Criteria: - Non-English-speaking children and families. - Any shoulder or wrist disarticulation will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Orlando Health Arnold Palmer Hospital for Children | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Orlando Health, Inc. | Limbitless Solutions, University of Central Florida |
United States,
Blough DK, Hubbard S, McFarland LV, Smith DG, Gambel JM, Reiber GE. Prosthetic cost projections for servicemembers with major limb loss from Vietnam and OIF/OEF. J Rehabil Res Dev. 2010;47(4):387-402. — View Citation
Canfield MA, Honein MA, Yuskiv N, Xing J, Mai CT, Collins JS, Devine O, Petrini J, Ramadhani TA, Hobbs CA, Kirby RS. National estimates and race/ethnic-specific variation of selected birth defects in the United States, 1999-2001. Birth Defects Res A Clin — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Children's Hand-use Experience Questionnaire | Children's Hand-use Experience Questionnaire is in PDF format We have developed the questionnaire to evaluate the experience of children and adolescents in using the affected hand or hand prostheses in activities where usually two hands are needed. | baseline thru 14 months post baseline | |
Other | PedsQL TM (Pediatric Quality of Life Inventory TM) | The PedsQL Measurement Model is a questionnaire that is designed to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. | baseline thru 14 months post baseline | |
Other | The use of the GUESS system for video gaming using the myoelectric device. | The GUESS is a psychometrically validated and comprehensive gaming scale with nine subscales (e.g., Usability/Playability, Creative Freedom, and Social Connectivity) and 55 items in total. The GUESS is intended for any playtesting and game evaluation purposes. | baseline thru 14 months post baseline | |
Other | The Pediatric Outcome Data Collection Instrument is a survey | The Pediatric Outcomes Data Collection Instrument (PODCI) is an outcomes assessment tool developed to allow measurement of health-related quality of life in children with disorders having musculoskeletal impact. This can be patient or parent reported and addresses activities of daily living. | baseline thru 14 months post baseline | |
Other | Psychosocial questionnaire to be completed by both patient and parent | This survey is designed to qualitatively identify any influence the use of the prosthetic device has throughout the study and for qualitative comparison across the patient population. | 14 month post baseline | |
Primary | Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device. | This data will be compared across the population using validated testing tools. | baseline thru 14 months post baseline. | |
Secondary | In-person testing of motor skills by an occupational therapist using blocks and a box. | Box and Blocks Test measures gross motor dexterity skills with an experienced occupational therapist with both dominant and non-dominant hand by moving blocks into a box in a specific timeframe while using the 3D myoelectric prosthetic device. This will be done at delivery of device, 5 months and 14 months after delivery. | baseline thru 14 months post baseline |
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