Congenital Abnormalities, Limb Deformities, Congenital, Upper Extremity Deformities, Congenital
Conditions
Brief summary
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.
Detailed description
Prosthetics for children are costly and those families who do get them often find that children don't use them for very long for a variety of reasons, including weight and ease of use. Limitless Solutions has developed technology to create personalized bionics for people with disabilities at an affordable cost. 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 free of charge. During each visit, the study team will include an occupational therapist, a prosthetist, a study coordinator, and a research volunteer along with Limitless support staff and a supervising physician. Subject will complete quality of life questionnaires throughout their participation.
Interventions
DEVICE3D myoelectric prosthetic device
All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.
Sponsors
Limbitless Solutions
University of Central Florida
Orlando Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device. | baseline thru 14 months post baseline. | This data will be compared across the population using validated testing tools. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-person testing of motor skills by an occupational therapist using blocks and a box. | baseline thru 14 months post baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The use of the GUESS system for video gaming using the myoelectric device. | baseline thru 14 months post baseline | 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. |
| Children's Hand-use Experience Questionnaire | baseline thru 14 months post baseline | 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. |
| Psychosocial questionnaire to be completed by both patient and parent | 14 month post baseline | 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. |
| The Pediatric Outcome Data Collection Instrument is a survey | baseline thru 14 months post baseline | 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. |
| PedsQL TM (Pediatric Quality of Life Inventory TM) | baseline thru 14 months post baseline | 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. |
Countries
United States
Contacts
Primary ContactAlbert Manero, PhD
Outcome results
None listed