Recruiting

Observational Study

Sponsor:

University of Nebraska

Code:

NCT04110730

Conditions

Amniotic Band Syndrome

Upper Extremity Deformities, Congenital

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Accepted

Interventions

3D Printed Upper-limb Prosthesis

Home Intervention

Study Details

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

Study ID

NCT04110730

Start date

Jan 10, 2020

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

3D Printed Upper-limb Prosthesis

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

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.

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. ]
  • Change of hemispheric dominance [ Time Frame: Change from baseline of hemispheric dominance at 8 weeks. ]
  • Change of synchrony of hand movement [ Time Frame: Change from baseline of synchrony of hand movement at 8 weeks. ]
  • Change of movement duration [ Time Frame: Change from baseline of movement duration at 8 weeks. ]

Central Contacts and Locations

Central contacts

Jorge M Zuniga, PhD

402-429-1288jmzuniga@unomaha.edu

Locations

University of Nebraska at Omaha

Recruiting

Omaha, Nebraska, United States, 68182

Contacts

Jorge M Zuniga, PhD

402-429-1288jmzuniga@unomaha.edu

More Information

Sponsor

University of Nebraska

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2025-09-25.