NCT05574075

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2024

Completed
Last Updated

December 16, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

October 5, 2022

Last Update Submit

December 11, 2024

Conditions

Keywords

Hand Strength, Child, Sensation, White matter

Outcome Measures

Primary Outcomes (1)

  • responsive grip behavior

    amplitude of pinch force development or adaptation to perturbation

    up to 2 years

Secondary Outcomes (5)

  • The Bayley Scales of Infant and Toddler Development, Third Edition

    up to 2 years

  • Peabody Developmental Motor Scales, Second Edition

    up to 2 years

  • Tuning Fork 128 Hz

    up to 2 years

  • Box and blocks test

    up to 2 years

  • Semmes-Weinstein monofilament test

    up to 2 years

Study Arms (2)

group of preterm and term children

group 1: preterm children group 2: term children

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

Interventions

white matter imaging markers

group of preterm and term children

Eligibility Criteria

Age2 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy adults: 20-39 years old term children: 24-60 months preterm children: 24-48 months

You may qualify if:

  • Must be able to do reach-to-grasp performance
  • Intact comprehension ability

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Study Start

January 12, 2023

Primary Completion

September 9, 2024

Study Completion

September 12, 2024

Last Updated

December 16, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations