Assessment of Neural and Motor Performance

NCT04241588 | Withdrawn FDA Device

• 1 other identifier: 0589-19-FB
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Amniotic Band Syndrome; Upper Extremity Deformities, Congenital

Outcome Measures

Primary Outcomes (4)

• 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.

  Change from baseline of movement duration at 4 months.

Secondary Outcomes (2)

• 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

Study Arms (2)

3D prostheses users

Children with unilateral congenital upper-limb reductions

Device: 3D Printed Upper-limb Prosthesis

Typically Developing Children

Age- and sex-matched control group of typically developing children.

Other: Control

Interventions

3D Printed Upper-limb Prosthesis DEVICE

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.

Also known as: Prosthesis use

3D prostheses users

Control OTHER

A 3D printed hand with be fitted to simulate a prosthesis.

Typically Developing Children

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nebraska residents and residents from other states will be invited to participate in the research study.

You may qualify if:

• Age 3-80 years.
• Individuals missing any digits, hand, arm, shoulder.
• Any dysfunction of the upper limbs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Amniotic Band Syndrome; Upper Extremity Deformities, Congenital

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities

Study Officials

• Jorge M Zuniga, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: November 22, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share