The Influence of 3D Printed Prostheses on Neural Activation Patterns

NCT04110730 | Recruiting FDA Device

• 1 other identifier: 0614-16-FB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amniotic Band Syndrome; Upper Extremity Deformities, Congenital

Outcome Measures

Primary Outcomes (4)

• Change of mean values of brain hemodynamic responses

  The oxy-hemoglobin (HbO) and deoxy-hemoglobin (HbR) are two major chromospheres in the blood which absorb NIR light. The concentration of HbO and HbR varies in the capillary blood during the rest and task sessions. Thus, brain functional information can be revealed by the estimation of HbO and HbR. HbT is the total hemoglobin.

  Change from baseline of mean values of brain hemodynamic responses at 8 weeks.

• Change of hemispheric dominance

  Measured using the Laterality Index revealing hemispheric dominance. The Laterality index will reveal hemispheric dominance using the following formula: Laterality index=(Oxy l-Oxy r)/(Oxy l+Oxy r) In this equation, l represents the channels from the left hemisphere and r indicates the channels from the right hemisphere. The Laterality index value will reveal which channels in the group showed a higher change during the task. Positive values indicate left-hemisphere dominant activation, while negative values indicate a right-hemisphere dominant activation.

  Change from baseline of hemispheric dominance at 8 weeks.

• Change of synchrony of hand movement

  The synchrony of hands movement will be quantified as the absolute temporal difference between hands (non-affected hand and affected hand with prosthesis) at six points in time while moving a bilateral instrumented tray.

  Change from baseline of synchrony of hand movement at 8 weeks.

• Change of movement duration

  Movement duration for unimanual and bimanual tasks while using an instrumented tray.

  Change from baseline of movement duration at 8 weeks.

Secondary Outcomes (2)

• Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).

  after 8 weeks.

• Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).

  after 8 weeks.

Study Arms (2)

3D Prostheses Users

EXPERIMENTAL

Children with unilateral congenital upper-limb reductions

Device: 3D Printed Upper-limb Prosthesis; Behavioral: Home Intervention

Typically Developing Children

ACTIVE COMPARATOR

Age- and sex-matched control group of typically developing children.

Behavioral: Home Intervention

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.

Also known as: Prosthesis use

3D Prostheses Users

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.

Also known as: Block stacking activity

3D Prostheses Users; Typically Developing Children

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 3-18 years.
• Individuals missing any digits, hand, arm, shoulder.
• Any dysfunction of the upper limbs.

You may not qualify if:

• Participants who are outside of age range.
• Participants with upper extremity injury within the past month.
• Medical conditions which would be contraindications to wear a prosthetic or assistive device, Such as skin abrasions and musculoskeletal injuries in the upper limbs.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

RECRUITING

Related Publications (1)

• Zuniga JM, Pierce JE, Copeland C, Cortes-Reyes C, Salazar D, Wang Y, Arun KM, Huppert T. Brain lateralization in children with upper-limb reduction deficiency. J Neuroeng Rehabil. 2021 Feb 3;18(1):24. doi: 10.1186/s12984-020-00803-1.

  PMID: 33536034 DERIVED

MeSH Terms

Conditions

Amniotic Band Syndrome; Upper Extremity Deformities, Congenital

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities

Study Officials

• Jorge M Zuniga, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge M Zuniga, PhD

CONTACT

402-429-1288; jmzuniga@unomaha.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: October 1, 2019
• Study Start: January 10, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)