The Influence of 3D Printed Prostheses on Neural Activation Patterns

Conditions

• Amniotic Band Syndrome
• Upper Extremity Deformities, Congenital

Eligibility Criteria

Sex

ALL

Age

3 Years - 18 Years

Healthy Volunteers

Accepted

Interventions

• 3D Printed Upper-limb Prosthesis — DEVICE
  The fingers and thumb were made of polylactic acid polymer manufactured using industrial 3D printers. The palm, socket, forearm brace, and leveraging structure were made of polylactic acid which has properties similar to thermoplastic that facilitate post manufacturing adjustments. Elastic cords placed inside the dorsal aspect of the fingers provided passive finger extension. Finger flexion was driven by non-elastic cords along the palmar surface of each finger and was activated through 20-30 degrees of wrist or elbow flexion.
• Home Intervention — BEHAVIORAL
  An occupational therapy student will perform 3 home visits a week and will direct a training protocol that consists of completing three trials of a series of 6 block building activities (i.e., block-stacking) for each hand separated by 30 seconds of rest (a total of 18 block building activities per hand). The block stacking activity consists in building a 4 block train, 3 cube bridge, 4 block wall, 3 block tower, 6 block steps, and 6 block pyramid. All subjects including the control group will perform the same home training protocol.

Study Details

The neural basis underlying motor performance in children using a prosthesis has been severely understudied resulting in minimal empirical evidence. The use of functional near-infrared spectroscopy (fNIRS) in conjunction with customized and visually appealing 3D printed prostheses would provide the unique opportunity to quantitatively assess the influence of upper-limb prostheses in the neural activation patterns of the primary motor cortex and motor performance of children. This information would increase the investigators limited knowledge of how prosthesis usage influences the primary motor cortex of growing children and use this information to develop rehabilitation programs aimed at reducing prosthesis rejection and abandonment.

Key Dates

Start date

Jan 10, 2020

Status verified

Sep 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: 3D Prostheses Users
  Children with unilateral congenital upper-limb reductions
• Active Comparator: Typically Developing Children
  Age- and sex-matched control group of typically developing children.

Primary Outcome Measure

Change of mean values of brain hemodynamic responses [ Time Frame: Change from baseline of mean values of brain hemodynamic responses at 8 weeks. ]

Central Contacts

• Jorge M Zuniga, PhD
  402-429-1288
  [email protected]

Locations (1)

Find similar trials in Omaha, NE

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