NCT04241588|WithdrawnFDA Device
Study Stopped
We did not received funding for this project, so we could not initiate enrollment.
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Sponsor study identifier
observational
0
0 countries
N/A
Study Start
November 22, 2022
Actual (reported)Primary Completion
November 22, 2022
Actual (reported)Study Completion
November 22, 2022
Actual (reported)The neural basis underlying motor performance in children using a prosthesis has been severely understudied resulting in minimal empirical evidence. With the use of low-cost 3D printed prosthetics, the purpose of this study is to examine the assessment of primary motor cortex activation and the representation of gray and white matter in a child with congenital limb loss. This will be accomplished by cross-examining results from fNIR and Anatomical Magnetic Resonance Imaging (MRI). The proposed research uses anatomical MRI to test if children with unilateral congenital partial hand reductions demonstrate less gray and white matter in the motor representation zones. Moreover, the proposed research will focus on an assessment of motor performance using continuous and discrete tasks with a robotic manipulandum. Assessment of motor performance and neural networking are critical to increasing our limited knowledge of how the child increases the number of motor repertoires.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2020
Actual (reported)January 27, 2020
Actual (reported)November 22, 2022
Actual (reported)November 22, 2022
Actual (reported)November 22, 2022
Actual (reported)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 4 month.
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 4 months.
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 retention and transfer of motor skills in 4 months.
Change of movement duration
Movement duration for continuous and discrete tasks will be measured while completing robotic manipulandum tasks.
Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).
After 1,2, and 4 months
Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).
After 1,2, and 4 months
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 the 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. The device will be given to participants so that they may practice using the device at home.
Nebraska residents and residents from other states will be invited to participate in the research study.
Jorge M Zuniga, PhD
University of Nebraska
0 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2020
First Posted
January 27, 2020
Study Start
November 22, 2022
Actual (reported)Data Collection Post Radical Prostatectomy
Change from baseline of movement duration at 4 months.
A 3D printed hand with be fitted to simulate a prosthesis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 22, 2022
Actual (reported)Study Completion
November 22, 2022
Actual (reported)Last Updated
September 3, 2024
Record last verified: 2024-08
Unidentified data
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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