The Influence of 3D Printed Prostheses on Neural Activation Patterns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorUniversity of Nebraska
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 3-18 years.
Individuals missing any digits, hand, arm, shoulder.
Any dysfunction of the upper limbs.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
3D Printed Upper-limb Prosthesis
DeviceThe 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.
Home Intervention
BehavioralAn 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 3D Prostheses UsersExperimental treatment 2 interventions
Group B: Typically Developing ChildrenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline of mean values of brain hemodynamic responses at 8 weeks.2
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.
Time frame
Change from baseline of hemispheric dominance at 8 weeks.3
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.
Time frame
Change from baseline of synchrony of hand movement at 8 weeks.4
Change of movement duration
Movement duration for unimanual and bimanual tasks while using an instrumented tray.
Time frame
Change from baseline of movement duration at 8 weeks.Secondary outcomes
1
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.
Time frame
after 8 weeks.2
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
Time frame
after 8 weeks.Sponsors and contacts
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Source ClinicalTrials.gov