Upper Limb Deformities, CongenitalNCT04059107
Prosthetic Device in Children With Upper Congenital Limb Deficiency
A study testing 3D Printed Myoelectric Prosthetic Device in people with Upper Limb Deformities, Congenital, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
This is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb deficiency. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Upper Limb Deformities, Congenital
- What is being tested?
- 3D Printed 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
- 2 sitesUnited States
- Study dates
- 3 Jul 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 6 to 17 with congenital/infant upper limb deficiency identified by Limbitless Solutions will be referred to OHSU for evaluation and selection.
- All approved and consented subjects will receive a Limbitless 3D printed myoelectric device as delivered by established protocol.
- Preference will be given to children with long term previous experience with Limbitless Solutions' bionic systems.
Who cannot join
- Non English-speaking children and families. Due to the entirely volunteer nature of this project, the investigators are unable to hire appropriate translation services or create translated forms and surveys in other languages currently.
- Shoulder or wrist disarticulation will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Central Florida
Orlando, Florida, 32816
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
This is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb deficiency.
Read the detailed description
The purpose of this study is to learn more about whether myoelectric prosthetic devices would be beneficial and useful for children. The study protocol specifies 4 study visits over the course of a year at the following intervals: baseline, 3 month, 6 month, 12 months. In following the protocol, each study visit will use the Assessment of Capacity for Myoelectric Control (ACMC) functional testing. The study participants will also complete several parent-child reported health related quality of life and musculoskeletal questionnaires. Specifically, the Pediatric Outcomes Data Collection Instrument (PODCI), the Pediatric Quality of Life Inventory (PedsQL), and the Children's Hand-Use Experience Questionnaire (CHEQ) will be used to measure efficacy of the myoelectric devices..
- Conditions
- Upper Limb Deformities, Congenital
- Being tested
- 3D Printed Myoelectric Prosthetic Device
- Medical subject headings
- Upper Extremity Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Myoelectric Prosthetic DeviceDevice
3D Printed Myoelectric Prosthetic Device
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic Device | Experimental | 3D Printed Myoelectric Prosthetic Device Receives: Device: 3D Printed Myoelectric Prosthetic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Measuring safety of the device through adverse event reporting.
The safety of the device will be measured through parental reporting and recorded observations of adverse events.
Measured: 12 months
Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire.
This assessment will measure the ability of the user to perform day-to-day tasks on three scales: grasp, performance time, and level of frustration.
Measured: 12 months
Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions.
This assessment will evaluate the ability of the myoelectric device use on functions that involve griping, holding, releasing, and coordinating between limbs using the Assessment of Capacity for Myoelectric Control (ACMC).
Measured: 12 months
This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user.
This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function.
Measured: 12 months
A self-report and parent-report sectional approach to measuring health-related quality of life.
This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start3 Jul 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (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 Upper Limb Deformities, CongenitalStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Limbitless Solutions, University of Central Florida
- Responsible party
- Principal investigator, Albert Chi, Oregon Health and Science University
- Investigators
- Albert Chi, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059107
- Sponsor's protocol ID
- OHSU IRB17087
- Status last verified
- Mar 2021
- First submitted
- 2 Jul 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Mol Teratol. 2006 Nov;76(11):747-56. doi: 10.1002/bdra.20294.
PubMed 17051527Blough 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 20803406
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
- ClinicalTrials.gov ID
- NCT04059107
- Acronym / sponsor ID
- OHSU IRB17087
- Conditions
- Upper Limb Deformities, Congenital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Limbitless Solutions, University of Central Florida
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Aug 2019 (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 is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb deficiency.
Detailed description
The purpose of this study is to learn more about whether myoelectric prosthetic devices would be beneficial and useful for children. The study protocol specifies 4 study visits over the course of a year at the following intervals: baseline, 3 month, 6 month, 12 months. In following the protocol, each study visit will use the Assessment of Capacity for Myoelectric Control (ACMC) functional testing. The study participants will also complete several parent-child reported health related quality of life and musculoskeletal questionnaires. Specifically, the Pediatric Outcomes Data Collection Instrument (PODCI), the Pediatric Quality of Life Inventory (PedsQL), and the Children's Hand-Use Experience Questionnaire (CHEQ) will be used to measure efficacy of the myoelectric devices..
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 Printed Myoelectric Prosthetic Device3D Printed Myoelectric Prosthetic Device |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between the ages of 6 to 17 with congenital/infant upper limb deficiency identified by Limbitless Solutions will be referred to OHSU for evaluation and selection.
- All approved and consented subjects will receive a Limbitless 3D printed myoelectric device as delivered by established protocol.
- Preference will be given to children with long term previous experience with Limbitless Solutions' bionic systems.
Key exclusion criteria (2 listed)
- Non English-speaking children and families. Due to the entirely volunteer nature of this project, the investigators are unable to hire appropriate translation services or create translated forms and surveys in other languages currently.
- 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 Printed Myoelectric Prosthetic Device3D Printed Myoelectric Prosthetic Device | Device | Prosthetic Device |
Primary outcome
Primary Safety Endpoint - Measuring safety of the device through adverse event reporting.
Time frame: 12 months
The safety of the device will be measured through parental reporting and recorded observations of adverse events.
Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire.
Time frame: 12 months
This assessment will measure the ability of the user to perform day-to-day tasks on three scales: grasp, performance time, and level of frustration.
Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions.
Time frame: 12 months
This assessment will evaluate the ability of the myoelectric device use on functions that involve griping, holding, releasing, and coordinating between limbs using the Assessment of Capacity for Myoelectric Control (ACMC).
This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user.
Time frame: 12 months
This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function.
A self-report and parent-report sectional approach to measuring health-related quality of life.
Time frame: 12 months
This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: 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.
- Background: 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.
- Facts about Upper and Lower Limb Reduction DefectsLink provided by the sponsor.
- Limbitless SolutionsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Albert Chi, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Myoelectric Prosthetic Device in people with Upper Limb Deformities, Congenital, run by Oregon Health and Science University at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - Measuring safety of the device through adverse event reporting. (time frame: 12 months). The study lists 5 primary outcomes in all. 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 NCT04059107, 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 10 Mar 2021.