Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population

June 9, 2022 updated by: Youngkook Kim, The Catholic University of Korea
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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of, 07345
        • Yeouido St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

  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
Time Frame: Four weeks

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 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

  1. Tracts of interest

    • CST
    • CPCT
    • DRTCT
    • DSCT
  2. Measurement of DTI-derived parameter

    • Mean Diffusivity (MD) values of the CST, CPCT, DRTCT, and DSCT
  3. 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
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

  1. Tracts of interest

    • CST
    • CPCT
    • DRTCT
    • DSCT
  2. Measurement of DTI-derived parameter

    • Tract volume (TV) values of the CST, CPCT, DRTCT, and DSCT
  3. Units and scoring of the Measurement

    • TV

      • mm^3
      • There is no limit on the range.
      • Higher scores indicate better microstructural integrity.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Youngkook Kim, Ph.D., Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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