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NCT Number: NCT05547308

Evaluation of 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.

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Key information

Conditions

Limb Deformities, Congenital Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Upper Extremity Deformities, Congenital

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location contact

Denise R. Lopez, APRN MSN

CONTACT

[email protected]

James E. Toledano, MD

SUB_INVESTIGATOR

Jason Keeler, MS

CONTACT

[email protected]

Mark A. Birnbaum, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D myoelectric prosthetic device

Device

All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.

Primary outcomes

  1. Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device.

    Time frame: baseline thru 14 months post baseline.

    This data will be compared across the population using validated testing tools.

Secondary outcomes

  1. In-person testing of motor skills by an occupational therapist using blocks and a box.

    Time frame: 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 outcomes

  1. Children's Hand-use Experience Questionnaire

    Time frame: 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.

  2. PedsQL TM (Pediatric Quality of Life Inventory TM)

    Time frame: 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.

  3. The use of the GUESS system for video gaming using the myoelectric device.

    Time frame: 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.

  4. The Pediatric Outcome Data Collection Instrument is a survey

    Time frame: 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.

  5. Psychosocial questionnaire to be completed by both patient and parent

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Manero, PhD

CONTACT

[email protected]

407 823-6757

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Collaborators

  • Limbitless Solutions
  • University of Central Florida

Registry information

Official study title

Evaluation of Gamified Training for 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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