Clinical trial NCT04110730: The Influence of 3D Printed Prostheses on Neural Activation Patterns
Official title: The Influence of 3D Printed Prostheses on Neural Activation Patterns of the Primary Motor Cortex in Children With Unilateral Congenital Upper-limb Reductions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amniotic Band Syndrome
Upper Extremity Deformities, Congenital
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The investigators anticipate enrolling a total of 40 children between 3 and 18 years of age. Specifically, two groups of children will be recruited; children with unilateral congenital upper-limb reductions (n=20) and age and sex-matched control group of typically developing children (n=20). Considering the effect size from preliminary data and to account for a 10% drop-out rate, a total sample of 40 subjects will provide 80% power to detect a true standardized effect size.

Participants will be asked to attend a total of 3 sessions. Participants will attend an initial measurement session to take a 3D scan of the affected and non-affected upper limbs as well as several anthropometric measurements. During this session, three pictures of the upper limbs will be taken which will also be used to verify the fit the prostheses in a process previously validated by our research team. The research participants will then be asked to come for two testing visits. During the first testing visit (visit 1), participants will be fitted with the prosthesis and required adjustments to improve comfort and avoid pressure point will be performed. After fitting the prosthesis, participants will be given 15 minutes to explore the prosthesis and adjust the tensioner dial to regulate the opening of the fingers to perform the Box and Block Test. After the training and accommodation period, participants will be asked to perform 3 trials of flexion and extension of each wrist with and without the prosthesis and 3 different trials of the Box and Blocks Test for each hand while monitoring neural activity of the primary motor cortex using a fNIRS device. After a period of 20 minutes rest, participants will be asked to perform three trials of a bimanual coordination test using an instrumented tray. The bimanual task will require participants to start from a standard position and then reach forward and grasp (hand-to-tray), transport and place a tray on a ledge (tray transport), and then return the hands to the starting position (hand return). This task will be performed unimanually (3 trials for each hand) and bimanually (3 trials using both hands). Eight weeks after the baseline measurements, participants will be asked to visit our laboratory for a second time and perform the same assessments. Between the testing visits, participants will be encouraged to use the prosthesis for a minimum of 2 hours a day. In addition, 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 for each hand separated by 30 seconds of rest (a total of 18 block building activities per hand). All participants including the control group will perform the same training protocol.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of mean values of brain hemodynamic responses
timeFrame: Change from baseline of mean values of brain hemodynamic responses at 8 weeks.
measure: Change of hemispheric dominance
timeFrame: Change from baseline of hemispheric dominance at 8 weeks.
measure: Change of synchrony of hand movement
timeFrame: Change from baseline of synchrony of hand movement at 8 weeks.
measure: Change of movement duration
timeFrame: Change from baseline of movement duration at 8 weeks.
Secondary outcomes:
measure: Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).
timeFrame: after 8 weeks.
measure: Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).
timeFrame: after 8 weeks.
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska at Omaha
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jorge M Zuniga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.