Hand Strength, Child, Sensation, White MatterNCT05574075
Assessment of Motor Adaptation in Precision Grip Performance of Children
An observational study of Hand Strength, Child, Sensation, White Matter, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Preterm children usually suffer from mild hand motor performance, however, the problem are rarely detected in time. Identifying the pathology causing deficits in sensorimotor control of a hand helps the occupational therapist to determine appropriate clinical decision-making for intervention. Read more about this study
- Who is it for?
- Ages 2 to 39 years
- Conditions the study is for
- Hand Strength, Child, Sensation, White Matter
- What is being tested?
- Diffusion tensor imaging
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jan 2023to 12 Sep 2024
- 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 2 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: healthy adults: 20-39 years old term children: 24-60 months preterm children: 24-48 months
Who may be able to join
- Must be able to do reach-to-grasp performance
- Intact comprehension ability
Who cannot join
- Diagnosis of cerebral palsy and other genetic or congenital damage
- Bone and nerve damage in the upper limbs in the past year
- Un-correctable problems of vision or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Motor Adaptation in Precision Grip Performance of Children: a Kinetic Analysis of Responsive Grip Behavior
Preterm children usually suffer from mild hand motor performance, however, the problem are rarely detected in time. Identifying the pathology causing deficits in sensorimotor control of a hand helps the occupational therapist to determine appropriate clinical decision-making for intervention. Well-motor performance requires complete sensorimotor control. Understanding hand sensorimotor control mechanism and its neural control can help clinicians find the reason behind hand motor deficits. The analysis of motion adaptation of the precision pinch behavior in the perturbing environment has been regarded as a clinically meaningful tool for evaluating sensorimotor control of a hand, especially for the complex anatomical structure of bone and tendon. The motor adaptation analysis for the precision grip behavior can provide the temporal and spatial parameters of dynamic grip force adjustment. Therefore, the exploration of motor adjustment can provide in-depth understanding of the neural mechanisms that lead to impairment of motor function and skill acquisition of a child, which can assist clinical occupational therapist in identifying the cause and severity of impairment of children's hand skills and provide appropriate strategies and types of treatment. The recent research on children's motor adaptation focuses on the discussion of the efficiency of motor adaptation in unfamiliar or disturbing task situations. Thus, the first purpose of this research is to develop an easy-to-detect apparatus to detect the adjustment efficiency of a responsive grip behavior of children in a disturbing pinch-lifting task and to construct the reliability of its evaluation. The second purpose of the research is to understand the correlation between the efficiency of children's reactive pinch performance adjustment and the results of traditional evaluation of fine motor development scale and sensorimotor control assessments. The third purpose of the research is to analyze the difference in motor adjustment of a precision pinch performance at different ages of preschool children. The fourth purpose is to compare the efficiency of motor adaptation in preterm and term children. In addition, preterm birth is often accompanied by white matter abnormalities and affects future hand motor performance. Investigating white matter imaging markers for predicting motor adaptation can help early detection of problems. Therefore, the fifth objective was to explore whether specific white matter imaging markers can predict the efficiency of reactive motor adaptation.
- Being tested
- Diffusion tensor imaging
- Keywords
- Hand Strength, Child, Sensation, White matter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion tensor imagingDiagnostic test
white matter imaging markers
| Study group | Role | What they receive |
|---|---|---|
| group of preterm and term children | group 1: preterm children group 2: term children Receives: Diagnostic Test: Diffusion tensor imaging | |
| group of different ages of preschool children | group 1: children with age of 25 months-36 months group 2: children with age of 37 months-48 months group 3: children with age of 49 months-60 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
responsive grip behavior
amplitude of pinch force development or adaptation to perturbation
Measured: up to 2 years
Secondary outcomes (5)
The Bayley Scales of Infant and Toddler Development, Third Edition
for diagnosing developmental delays in early childhood
Measured: up to 2 years
Peabody Developmental Motor Scales, Second Edition
measure interrelated motor abilities of children from birth through age 5 years of age
Measured: up to 2 years
Tuning Fork 128 Hz
measure vibration sense
Measured: up to 2 years
Box and blocks test
measure upper limb coordination
Measured: up to 2 years
Semmes-Weinstein monofilament test
measure touch-pressure sense
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start12 Jan 2023
- Primary completion9 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand Strength, Child, Sensation, White MatterStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574075
- Sponsor's protocol ID
- B-BR-110-072
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu HY, Yu JN, Lin YC, Su HC, Koh CL, Kuo LC. Impact of hemispheric specialization on reactive upper limb motor control after perturbations via a newly designed reactive pinch-holding-up activity test. Clin Biomech (Bristol). 2025 Aug;128:106607. doi: 10.1016/j.clinbiomech.2025.106607. Epub 2025 Jul 4.
PubMed 40633224
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Motor Adaptation in Precision Grip Performance of Children: a Kinetic Analysis of Responsive Grip Behavior
- ClinicalTrials.gov ID
- NCT05574075
- Acronym / sponsor ID
- B-BR-110-072
- Keywords
- Hand Strength, Child, Sensation, White matter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 10 Oct 2022 (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.
Preterm children usually suffer from mild hand motor performance, however, the problem are rarely detected in time. Identifying the pathology causing deficits in sensorimotor control of a hand helps the occupational therapist to determine appropriate clinical decision-making for intervention. Well-motor performance requires complete sensorimotor control. Understanding hand sensorimotor control mechanism and its neural control can help clinicians find the reason behind hand motor deficits. The analysis of motion adaptation of the precision pinch behavior in the perturbing environment has been regarded as a clinically meaningful tool for evaluating sensorimotor control of a hand, especially for the complex anatomical structure of bone and tendon. The motor adaptation analysis for the precision grip behavior can provide the temporal and spatial parameters of dynamic grip force adjustment. Therefore, the exploration of motor adjustment can provide in-depth understanding of the neural mechanisms that lead to impairment of motor function and skill acquisition of a child, which can assist clinical occupational therapist in identifying the cause and severity of impairment of children's hand skills and provide appropriate strategies and types of treatment. The recent research on children's motor adaptation focuses on the discussion of the efficiency of motor adaptation in unfamiliar or disturbing task situations. Thus, the first purpose of this research is to develop an easy-to-detect apparatus to detect the adjustment efficiency of a responsive grip behavior of children in a disturbing pinch-lifting task and to construct the reliability of its evaluation. The second purpose of the research is to understand the correlation between the efficiency of children's reactive pinch performance adjustment and the results of traditional evaluation of fine motor development scale and sensorimotor control assessments. The third purpose of the research is to analyze the difference in motor adjustment of a precision pinch performance at different ages of preschool children. The fourth purpose is to compare the efficiency of motor adaptation in preterm and term children. In addition, preterm birth is often accompanied by white matter abnormalities and affects future hand motor performance. Investigating white matter imaging markers for predicting motor adaptation can help early detection of problems. Therefore, the fifth objective was to explore whether specific white matter imaging markers can predict the efficiency of reactive motor adaptation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of preterm and term children | – | Diagnostic Test: Diffusion tensor imaginggroup 1: preterm children group 2: term children |
| group of different ages of preschool children | – | –group 1: children with age of 25 months-36 months group 2: children with age of 37 months-48 months group 3: children with age of 49 months-60 months |
Who may qualify
- Ages
- 2 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- healthy adults: 20-39 years old term children: 24-60 months preterm children: 24-48 months
Key inclusion criteria (2 listed)
- Must be able to do reach-to-grasp performance
- Intact comprehension ability
Key exclusion criteria (3 listed)
- Diagnosis of cerebral palsy and other genetic or congenital damage
- Bone and nerve damage in the upper limbs in the past year
- Un-correctable problems of vision or hearing impairment
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 |
|---|---|---|
| Diffusion tensor imagingwhite matter imaging markers | Diagnostic test | group of preterm and term children |
Primary outcome
responsive grip behavior
Time frame: up to 2 years
amplitude of pinch force development or adaptation to perturbation
5 secondary outcomes
The Bayley Scales of Infant and Toddler Development, Third Edition
Time frame: up to 2 years
Peabody Developmental Motor Scales, Second Edition
Time frame: up to 2 years
Tuning Fork 128 Hz
Time frame: up to 2 years
Box and blocks test
Time frame: up to 2 years
Semmes-Weinstein monofilament test
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 40633224Hsu HY, Yu JN, Lin YC, Su HC, Koh CL, Kuo LC. Impact of hemispheric specialization on reactive upper limb motor control after perturbations via a newly designed reactive pinch-holding-up activity test. Clin Biomech (Bristol). 2025 Aug;128:106607. doi: 10.1016/j.clinbiomech.2025.106607. Epub 2025 Jul 4.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Strength, Child, Sensation, White Matter, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
responsive grip behavior (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05574075, which also lists 1 linked publication.
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 16 Dec 2024.