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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04934319
Other study ID # SC20FISI0152
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2021
Est. completion date December 31, 2021

Study information

Verified date June 2022
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The cerebellum is involved in regulating balance and walking and plays a crucial role in the locomotor adaptation and learning processes. This study aims to investigate the association between balance and the integrity of the cerebellar white matter tracts in a healthy population. Healthy participants will undergo four weeks of balance training. The investigators will analyze changes in the microstructural integrity of the cerebellar white matter tract before and after four weeks of balance training.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 31, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 74 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Balance and Proprioceptive Training
Step-by-step training (5 levels) 30 minute per training 3 times per week Four weeks

Locations

Country Name City State
Korea, Republic of Yeouido St. Mary's Hospital Seoul Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional anisotropy of the cerebellar white matter tracts Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training
Tracts of interest
Corticospinal tract (CST)
Cortico-ponto-cerebellar tract (CPCT)
Dentato-rubro-thalamo-cortical tract (DRTCT)
Dorsal spinocerebellar tract (DSCT)
Measurement of DTI-derived parameter
Fractional anisotropy (FA) values of the CST, CPCT, DRTCT, and DSCT
Units and scoring of the Measurement
FA
No unit.
The measurement ranges from 0 to 1
Higher scores indicate better microstructural integrity.
Four weeks
Primary Community Balance & Mobility Scale Performance measure before and after balance and proprioceptive training
Measurement
13 domain
Unilateral stance, Tandem walking, 180° tandem pivot, Lateral foot scooting, Hopping forward, Crouch and walk, Lateral dodging, Walking & looking, Running with controlled stop, Forward to backward walking, Walk look and carry, Descending stairs, Step-ups x 1 step
Scoring of the Measurement
No units.
The measurement ranges from 0 to 96
Higher scores indicate better postural balance and mobility.
Four weeks
Secondary Mean diffusivity of the cerebellar white matter tracts Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training
Tracts of interest
CST
CPCT
DRTCT
DSCT
Measurement of DTI-derived parameter
Mean Diffusivity (MD) values of the CST, CPCT, DRTCT, and DSCT
Units and scoring of the Measurement
MD
mm^2/second
There is no limit on the range (usually ranges 0.00005 - 0.0001 mm^2/second).
Higher scores indicate worse microstructural integrity.
Four weeks
Secondary Tract volume of the cerebellar white matter tracts Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training
Tracts of interest
CST
CPCT
DRTCT
DSCT
Measurement of DTI-derived parameter
Tract volume (TV) values of the CST, CPCT, DRTCT, and DSCT
Units and scoring of the Measurement
TV
mm^3
There is no limit on the range.
Higher scores indicate better microstructural integrity.
Four weeks
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