Limb Deformities, CongenitalNCT05547308
Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
A study testing 3D myoelectric prosthetic device in people with Limb Deformities, Congenital and Upper Extremity Deformities, Congenital, run by Orlando Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Limb Deformities, Congenital, Upper Extremity Deformities, Congenital, Congenital Abnormalities
- What is being tested?
- 3D myoelectric prosthetic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 7 to 17
- Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions.
Who cannot join
- Non-English-speaking children and families.
- Any shoulder or wrist disarticulation will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Denise R. Lopez, APRN MSN, denise.lopez@orlandohealth.com
Jason Keeler, MS, jason.keeler@orlandohealth.com
About this study
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.
Read the 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.
- Conditions
- Limb Deformities, Congenital, Upper Extremity Deformities, Congenital, Congenital Abnormalities
- Being tested
- 3D myoelectric prosthetic device
- Medical subject headings
- Limb Deformities, Congenital, Upper Extremity Deformities, Congenital, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D myoelectric prosthetic deviceDevice
All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic device | Experimental | All subjects will receive the 3D myoelectric prosthetic device Receives: Device: 3D myoelectric prosthetic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline thru 14 months post baseline.
Secondary outcomes (1)
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.
Measured: baseline thru 14 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Limb Deformities, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Limbitless Solutions, University of Central Florida
- Responsible party
- Sponsor
- Investigators
- Albert Manero, PhD, Study director, Limbitless Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547308
- Sponsor's protocol ID
- 2017710limbitlessprosthetic
- Status last verified
- Sep 2022
- First submitted
- 25 Apr 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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. doi: 10.1682/jrrd.2009.04.0037.
PubMed 20803406Canfield 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 Mol Teratol. 2006 Nov;76(11):747-56. doi: 10.1002/bdra.20294.
PubMed 17051527
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gamified Training for 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
- ClinicalTrials.gov ID
- NCT05547308
- Acronym / sponsor ID
- 2017710limbitlessprosthetic
- Conditions
- Limb Deformities, Congenital, Upper Extremity Deformities, Congenital, Congenital Abnormalities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Collaborators
- Limbitless Solutions, University of Central Florida
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic device | Experimental | Device: 3D myoelectric prosthetic deviceAll subjects will receive the 3D myoelectric prosthetic device |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between the ages of 7 to 17
- Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions.
Key exclusion criteria (2 listed)
- Non-English-speaking children and families.
- Any shoulder or wrist disarticulation will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D myoelectric prosthetic deviceAll subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires. | Device | Prosthetic device |
Primary outcome
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.
1 secondary outcome
In-person testing of motor skills by an occupational therapist using blocks and a box.
Time frame: baseline thru 14 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Results publication: PubMed 20803406Blough 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. doi: 10.1682/jrrd.2009.04.0037.
- Results publication: PubMed 17051527Canfield 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 Mol Teratol. 2006 Nov;76(11):747-56. doi: 10.1002/bdra.20294.
- Limbitless Solutions, Inc.Link provided by the sponsor.
- Facts about Upper and Lower Limb Reduction DefectsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Limb Deformities, Congenital
RecruitingObservational study
Study of Infantile Lower Limb Malformations and Deformities
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Fracture, Lengthening; Leg
Recruiting
Adaptive Rock Climbing
Congenital Upper Limb Differences
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert Manero, PhD study director
Limbitless Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D myoelectric prosthetic device in people with Limb Deformities, Congenital and Upper Extremity Deformities, Congenital, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Manero, PhD (407 823-6757, contact@limbitless-solutions.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547308, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.