Upper Extremity Deformities, Congenital Clinical Trial
Official title:
The Influence of 3D Printed Prostheses on Neural Activation Patterns of the Primary Motor Cortex in Children With Unilateral Congenital Upper-limb Reductions
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska at Omaha | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Change of movement duration | Movement duration for unimanual and bimanual tasks while using an instrumented tray. | Change from baseline of movement duration at 8 weeks. | |
Secondary | 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. | after 8 weeks. | |
Secondary | 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 | after 8 weeks. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04241588 -
Assessment of Neural and Motor Performance
|
||
Not yet recruiting |
NCT05547308 -
Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
|
N/A | |
Enrolling by invitation |
NCT05328934 -
SoftHand Comparison Study
|
N/A |