Assessment of Neural and Motor Performance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04241588|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment|
|Amniotic Band Syndrome Upper Extremity Deformities, Congenital||Device: 3D Printed Upper-limb Prosthesis|
The investigators anticipate enrolling a total of 40children 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.
All subjects including controls will attend four data collection sessions that will include: one fitting session, second to obtain a baseline, the third visit will be one month after baseline, and the final visit will be four months after baseline. Participants will attend an initial measurement session to take a 3D scan of the affected and nonaffected 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 subjects will then perform an anatomical MRI scan. The MRI scan is not a clinical scan intended for diagnostic or therapeutic purposes. 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 brief period of rest and encouragement, the subject will be asked to perform eight trials of discrete (four trials) and continuous (four trials) tasks using a robotic manipulandum (InMotion Arm Robot, Interactive Motion Technologies, Inc., Cambridge, MA, USA). These tasks have been previously used for the assessment of changes in upper-limb performance and the effect of different treatments in the recovering of motor function of children with acquired or congenital hemiparesis, ataxia, and hemiparesis. This data collection performed at baseline will be performed again one and four months after baseline. 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Assessment of Neural and Motor Performance in Upper Limb Deficient Subjects Using Discrete and Continuous Tasks. Anatomical Differences of Brain Gray and White Matter Resulting From Unilateral Congenital Upper Limb Loss|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
3D prostheses users
Children with unilateral congenital upper-limb reductions
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 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.
Other Name: Prosthesis use
Typically Developing Children
Age- and sex-matched control group of typically developing children.
- Change of mean values of brain hemodynamic responses [ Time Frame: Change from baseline of mean values of brain hemodynamic responses at 4 month. ]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 of hemispheric dominance [ Time Frame: Change from baseline of hemispheric dominance at 4 months. ]
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 of synchrony of hand movement [ Time Frame: Change from baseline of retention and transfer of motor skills in 4 months. ]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 of movement duration [ Time Frame: Change from baseline of movement duration at 4 months. ]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). [ Time Frame: After 1,2, and 4 months ]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.
- Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS). [ Time Frame: After 1,2, and 4 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241588
|Contact: Jorge M Zuniga, Ph.D.||email@example.com|
|United States, Nebraska|
|University of Nebraska Omaha|
|Omaha, Nebraska, United States, 68182|
|Contact: Jorge M Zuniga, Ph.D. 402-429-1288|