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.
Children between the ages of 7 to 17
Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions.
Non-English-speaking children and families.
Any shoulder or wrist disarticulation will be excluded.
Single group
3D myoelectric prosthetic device
DeviceAll subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.
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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Orlando Health, Inc.
Lead sponsor
Limbitless Solutions
Collaborator
University of Central Florida
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
