Amniotic Band SyndromeNCT04241588
Assessment of Neural and Motor Performance
An observational study of Amniotic Band Syndrome and Upper Extremity Deformities, Congenital, run by University of Nebraska.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amniotic Band Syndrome, Upper Extremity Deformities, Congenital
- What is being tested?
- 3D Printed Upper-limb Prosthesis
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2022to 22 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nebraska residents and residents from other states will be invited to participate in the research study.
Who may be able to join
- Age 3-80 years.
- Individuals missing any digits, hand, arm, shoulder.
- Any dysfunction of the upper limbs.
Who cannot join
- 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.
About this study
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
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.
Read the detailed description
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.
- Being tested
- 3D Printed Upper-limb Prosthesis, Control
- Medical subject headings
- Amniotic Band Syndrome, Upper Extremity Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Upper-limb ProsthesisDevice
Also called Prosthesis use
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.
ControlOther
A 3D printed hand with be fitted to simulate a prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| 3D prostheses users | Children with unilateral congenital upper-limb reductions Receives: Device: 3D Printed Upper-limb Prosthesis | |
| Typically Developing Children | Age- and sex-matched control group of typically developing children. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline of movement duration at 4 months.
Secondary outcomes (2)
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.
Measured: After 1,2, and 4 months
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.
Measured: After 1,2, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start22 Nov 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Why it stopped: We did not received funding for this project, so we could not initiate enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Band SyndromeStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge M Zuniga, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241588
- Sponsor's protocol ID
- 0589-19-FB
- Status last verified
- Aug 2024
- First submitted
- 22 Jan 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Unidentified data
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04241588
- Acronym / sponsor ID
- 0589-19-FB
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We did not received funding for this project, so we could not initiate enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D prostheses users | – | Device: 3D Printed Upper-limb ProsthesisChildren with unilateral congenital upper-limb reductions |
| Typically Developing Children | – | Other: ControlAge- and sex-matched control group of typically developing children. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nebraska residents and residents from other states will be invited to participate in the research study.
Key inclusion criteria (3 listed)
- Age 3-80 years.
- Individuals missing any digits, hand, arm, shoulder.
- Any dysfunction of the upper limbs.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Printed Upper-limb ProsthesisAlso: Prosthesis useThe 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. | Device | 3D prostheses users |
| ControlA 3D printed hand with be fitted to simulate a prosthesis. | Other | Typically Developing Children |
Primary outcome
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.
2 secondary outcomes
Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).
Time frame: After 1,2, and 4 months
Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).
Time frame: After 1,2, and 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No. Unidentified data
Related trials for Amniotic Band Syndrome
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The Influence of 3D Printed Prostheses on Neural Activation Patterns
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Level Up! Adaptive Gaming for Children With Upper Limb Differences
Upper Limb Amputation at the Wrist, Pediatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge M Zuniga, PhD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
An observational study of Amniotic Band Syndrome and Upper Extremity Deformities, Congenital, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean values of brain hemodynamic responses (time frame: Change from baseline of mean values of brain hemodynamic responses at 4 month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.