The Influence of 3D Printed Prostheses on Neural Activation Patterns

Upper Extremity Deformities, Congenital Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110730
• Other study ID #: 0614-16-FB
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: Jorge M Zuniga, PhD
• Phone: 402-429-1288
• Email: jmzuniga[@]unomaha.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amniotic Band Syndrome
• Upper Extremity Deformities, Congenital

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Nebraska at Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).	The parents of the participants select a response for each question using the following categories which are scored from 0 to 4: "not at all" =0, "a little" =1, "somewhat" =2, "a lot" =3, or "very much" =4. A higher score indicates higher satisfaction. The CAPP-PSI is a standardized measure of prosthesis satisfaction in children with limb deficiency.	after 8 weeks.
Secondary	Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).	The parents of the participants select a response for each question using the following categories which are scored from 5=Very Satisfied, 4= Somewhat satisfied, 3=Neither, satisfied nor dissatisfied, 2=Somewhat dissatisfied, 1=Very Dissatisfied. A higher score indicates higher satisfaction. The OPUS is a self-report questionnaire consisting of five modules. Module 5 (OPUS Satisfaction) will be used to assess different satisfaction element	after 8 weeks.