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Completed

NCT Number: NCT04934319

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

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.

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Key information

Conditions

Balance Cerebellum

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeouido St. Mary's Hospital

Seoul, Yeongdeungpo-gu, 07345, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance and Proprioceptive Training

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

Primary outcomes

  1. 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

    • 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.

  2. Community Balance & Mobility Scale

    Time frame: Four weeks

    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.

Secondary outcomes

  1. 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

    • 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.

  2. 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

    • 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.

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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