- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04934319
Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The cerebellum is involved in regulating balance and walking and plays a crucial role in the locomotor adaptation and learning processes. The cerebellum's intermediate zone, which receives afferent stimuli from the sensorimotor cortex (via the cortico-ponto-cerebellar tract) and peripheral muscles (via the dorsal spinocerebellar tract), contributes to maintaining body posture and regulating walking. Proprioceptive information from the peripheral muscles passes through the dorsal spinocerebellar tract, enters the ipsilateral cerebellar hemisphere via the inferior cerebellar peduncle, and finally projects to the contralateral motor cortex through the cerebello-thalamo-cortical pathways.
Diffusion tensor imaging (DTI) enables microstructural evaluation of the white matter tracts. Both diffusion tensor tractography, to determine the structural connectivity of the whole tract, and DTI-derived parameters, to determine the microstructural organization, can represent the integrity of the cerebellar white matter tracts.
The investigators will evaluate the motor-related white matter tracts, including the corticospinal tract, the cortico-ponto-cerebellar tract, the dorsal spinocerebellar tract, and the dentato-rubro-thalamo-cortical tract. Healthy participants will perform the four weeks of balance training, and DTI will be acquired before and after exercise. The investigators will analyze the DTI-derived parameters of the relevant white matter tracts and analyze the longitudinal changes. The investigators hypothesized that the four weeks of balance training would enhance the integrity of the cerebellar white matter tracts.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yeongdeungpo-gu
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Seoul, Yeongdeungpo-gu, Korea, Republic of, 07345
- Yeouido St. Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mini-mental state examination >=26
- Independent outdoor ambulator
Exclusion Criteria:
- Men/women with any metal implants in their body
- A prior history of psychopathology or a neurological disorders
- A prior history of osteoporosis, advanced osteoarthritis (K-L grade >=3), surgical history of hip or knee arthroplasty
- If any structural abnormalities are detected on their scan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Balance training
A single training group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional anisotropy of the cerebellar white matter tracts
Time Frame: Four weeks
|
Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training
|
Four weeks
|
|
Community Balance & Mobility Scale
Time Frame: Four weeks
|
Performance measure before and after balance and proprioceptive training
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean diffusivity of the cerebellar white matter tracts
Time Frame: Four weeks
|
Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training
|
Four weeks
|
|
Tract volume of the cerebellar white matter tracts
Time Frame: Four weeks
|
Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training
|
Four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Youngkook Kim, Ph.D., Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Publications and helpful links
General Publications
- Kim JS, Kim SH, Lim SH, Im S, Hong BY, Oh J, Kim Y. Degeneration of the Inferior Cerebellar Peduncle After Middle Cerebral Artery Stroke: Another Perspective on Crossed Cerebellar Diaschisis. Stroke. 2019 Oct;50(10):2700-2707. doi: 10.1161/STROKEAHA.119.025723. Epub 2019 Aug 26.
- Kim Y, Kim SH, Kim JS, Hong BY. Modification of Cerebellar Afferent Pathway in the Subacute Phase of Stroke. J Stroke Cerebrovasc Dis. 2018 Sep;27(9):2445-2452. doi: 10.1016/j.jstrokecerebrovasdis.2018.04.039. Epub 2018 May 22.
- Kim Y, Im S, Kim SH, Park GY. Laterality of cerebellar afferent and efferent pathways in a healthy right-handed population: A diffusion tensor imaging study. J Neurosci Res. 2019 May;97(5):582-596. doi: 10.1002/jnr.24378. Epub 2018 Dec 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SC20FISI0152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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