- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110730
The Influence of 3D Printed Prostheses on Neural Activation Patterns
The Influence of 3D Printed Prostheses on Neural Activation Patterns of the Primary Motor Cortex in Children With Unilateral Congenital Upper-limb Reductions
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jorge M Zuniga, PhD
- Phone Number: 402-429-1288
- Email: jmzuniga@unomaha.edu
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68182
- Recruiting
- University of Nebraska at Omaha
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Contact:
- Jorge M Zuniga, PhD
- Phone Number: 402-429-1288
- Email: jmzuniga@unomaha.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D Prostheses Users
Children with unilateral congenital upper-limb reductions
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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.
Other Names:
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.
Other Names:
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Active Comparator: Typically Developing Children
Age- and sex-matched control group of typically developing children.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of mean values of brain hemodynamic responses
Time Frame: Change from baseline of mean values of brain hemodynamic responses at 8 weeks.
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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.
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Change from baseline of mean values of brain hemodynamic responses at 8 weeks.
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Change of hemispheric dominance
Time Frame: Change from baseline of hemispheric dominance at 8 weeks.
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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.
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Change of synchrony of hand movement
Time Frame: Change from baseline of synchrony of hand movement at 8 weeks.
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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.
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Change from baseline of synchrony of hand movement at 8 weeks.
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Change of movement duration
Time Frame: Change from baseline of movement duration at 8 weeks.
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Movement duration for unimanual and bimanual tasks while using an instrumented tray.
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Change from baseline of movement duration at 8 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).
Time Frame: after 8 weeks.
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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.
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after 8 weeks.
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Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).
Time Frame: after 8 weeks.
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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
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after 8 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jorge M Zuniga, PhD, University of Nebraska
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0614-16-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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