NCT04110730|RecruitingFDA Device
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Sponsor study identifier
interventional
40
1 country
1
Study Start
January 10, 2020
Actual (reported)Primary Completion
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2019
Actual (reported)October 1, 2019
Actual (reported)January 10, 2020
Actual (reported)August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Children with unilateral congenital upper-limb reductions
Age- and sex-matched control group of typically developing children.
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.
University of Nebraska at Omaha
Omaha, Nebraska, 68182, United States
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.
Jorge M Zuniga, PhD
University of Nebraska
First Submitted
September 22, 2019
First Posted
October 1, 2019
Study Start
January 10, 2020
Actual (reported)Primary Completion
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
Change from baseline of movement duration at 8 weeks.
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.
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Study Completion
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
Unidentified data
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Source: ClinicalTrials.gov.
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