3D Printed Prostheses for Upper Extremity Deformities

N/A

Recruiting

Led By Jorge M Zuniga, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 3-18 years

Any dysfunction of the upper limbs

Must not have

Participants who are outside of age range

Medical conditions which would be contraindications to wear a prosthetic or assistive device, such as skin abrasions and musculoskeletal injuries in the upper limbs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline of movement duration at 8 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial will use fNIRS to study how a prosthesis affects the primary motor cortex of children, and whether this information can be used to improve rehabilitation programs for children using prostheses.

Who is the study for?

This trial is for children and teens aged 3-18 with missing digits or parts of their arm due to conditions like Amniotic Band Syndrome. They should be able to wear a prosthetic but can't join if they have recent injuries, skin issues, or other medical problems that make using a prosthetic difficult.

What is being tested?

The study tests how cool-looking, custom-made 3D printed upper-limb prostheses affect brain activity related to movement in kids. Researchers will use special imaging (fNIRS) to see changes in the motor cortex when these prostheses are used.

What are the potential side effects?

Since this trial involves non-invasive home interventions and wearing a prosthesis, side effects might include discomfort from wearing the device or skin irritation at contact points.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 18 years old.

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I have problems with the movement or function of my arms or hands.

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I am missing a digit, hand, arm, or shoulder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not within the specified age range for the trial.

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I don't have skin or muscle issues that prevent wearing a prosthetic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline of mean values of brain hemodynamic responses at 8 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline of mean values of brain hemodynamic responses at 8 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline of mean values of brain hemodynamic responses at 8 weeks. for reporting.