Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05547308
Other study ID # 2017710limbitlessprosthetic
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2022
Est. completion date November 2027

Study information

Verified date September 2022
Source Orlando Health, Inc.
Contact Albert Manero, PhD
Phone 407 823-6757
Email contact@limbitless-solutions.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Orlando Health Arnold Palmer Hospital for Children Orlando Florida

Sponsors (3)

Lead Sponsor Collaborator
Orlando Health, Inc. Limbitless Solutions, University of Central Florida

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05883761 - Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment
Completed NCT00766571 - Clinical and Genetic Studies of VACTERL Association
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Not yet recruiting NCT05393167 - Congenital Anomalies in Infants of Diabetic Mother
Recruiting NCT05151042 - Digital Occlusal Wafer Versus Waferless Distal Segment Repositioning for BSSO in Skeletal Mandibular Deformities N/A
Recruiting NCT05738954 - Pattern Recognition and Anomaly Detection in Fetal Morphology Using Deep Learning and Statistical Learning
Recruiting NCT02505464 - Pregnancies Complicated by Fetal Anomalies
Recruiting NCT02595307 - Improving Informed Consent for Cleft Palate Repair N/A
Completed NCT00477594 - Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia Phase 2
Completed NCT00062452 - Esophageal Motility and Airway Defenses Among Infants N/A
Recruiting NCT05763615 - 3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project N/A
Terminated NCT02351726 - Mitroflow DL Post Approval Study- North America N/A
Recruiting NCT04591392 - Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD N/A
Not yet recruiting NCT05231447 - Birth Defect Registry in South West Region of France
Completed NCT02429947 - An Analysis of the Symptomatic Domains Most Relevant to Charcot Marie Tooth Neuropathy (CMT) Patients N/A
Completed NCT01653392 - BioThrax® (Anthrax) Vaccine in Pregnancy Registry
Completed NCT00607373 - Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT00362180 - Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration Phase 2
Active, not recruiting NCT02987387 - COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
Completed NCT02875860 - 'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial Phase 2