NCT05547308

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2022Nov 2027

First Submitted

Initial submission to the registry

April 25, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

April 25, 2022

Last Update Submit

September 16, 2022

Conditions

Limb Deformities, CongenitalUpper Extremity Deformities, CongenitalCongenital Abnormalities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    baseline thru 14 months post baseline

Other Outcomes (5)

  • Children's Hand-use Experience Questionnaire

    baseline thru 14 months post baseline

  • PedsQL TM (Pediatric Quality of Life Inventory TM)

    baseline thru 14 months post baseline

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

    baseline thru 14 months post baseline

  • +2 more other outcomes

Study Arms (1)

Prosthetic device

EXPERIMENTAL

All subjects will receive the 3D myoelectric prosthetic device

Device: 3D myoelectric prosthetic device

Interventions

3D myoelectric prosthetic deviceDEVICE

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

Prosthetic device

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of 7 to 17
  • Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions.

You may not qualify if:

  • Non-English-speaking children and families.
  • Any shoulder or wrist disarticulation will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Related 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. doi: 10.1682/jrrd.2009.04.0037.

    PMID: 20803406RESULT

  • 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.

    PMID: 17051527RESULT

Related Links

MeSH Terms

Conditions

Limb Deformities, CongenitalUpper Extremity Deformities, CongenitalCongenital Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Albert Manero, PhD

    Limbitless Solutions

    STUDY DIRECTOR

Central Study Contacts

Albert Manero, PhD

CONTACT

407 823-6757contact@limbitless-solutions.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

September 21, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2027

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)