NCT04934319

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 7, 2021

Last Update Submit

June 9, 2022

Conditions

Keywords

BalanceCerebellumWhite matter tractDiffusion Tensor Imaging

Outcome Measures

Primary Outcomes (2)

  • Fractional anisotropy of the cerebellar white matter tracts

    Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training 1. Tracts of interest * Corticospinal tract (CST) * Cortico-ponto-cerebellar tract (CPCT) * Dentato-rubro-thalamo-cortical tract (DRTCT) * Dorsal spinocerebellar tract (DSCT) 2. Measurement of DTI-derived parameter * Fractional anisotropy (FA) values of the CST, CPCT, DRTCT, and DSCT 3. Units and scoring of the Measurement * FA * No unit. * The measurement ranges from 0 to 1 * Higher scores indicate better microstructural integrity.

    Four weeks

  • Community Balance & Mobility Scale

    Performance measure before and after balance and proprioceptive training 1. 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 2. Scoring of the Measurement * No units. * The measurement ranges from 0 to 96 * Higher scores indicate better postural balance and mobility.

    Four weeks

Secondary Outcomes (2)

  • Mean diffusivity of the cerebellar white matter tracts

    Four weeks

  • Tract volume of the cerebellar white matter tracts

    Four weeks

Study Arms (1)

Balance training

EXPERIMENTAL

A single training group

Behavioral: Balance and Proprioceptive Training

Interventions

* Step-by-step training (5 levels) * 30 minute per training * 3 times per week * Four weeks

Balance training

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mini-mental state examination \>=26
  • Independent outdoor ambulator

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeouido St. Mary's Hospital

Seoul, Yeongdeungpo-gu, 07345, South Korea

Location

Related 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.

    PMID: 31446886BACKGROUND
  • 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.

    PMID: 29801815BACKGROUND
  • 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.

    PMID: 30582195BACKGROUND

Study Officials

  • Youngkook Kim, Ph.D.

    Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 22, 2021

Study Start

May 24, 2021

Primary Completion

October 30, 2021

Study Completion

December 31, 2021

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations