BalanceNCT04934319
Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population
A study testing Balance and Proprioceptive Training in people with Balance and Cerebellum, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance, Cerebellum
- What is being tested?
- Balance and Proprioceptive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mini-mental state examination >=26
- Independent outdoor ambulator
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yeouido St. Mary's Hospital
Seoul, Yeongdeungpo-gu, 07345
About this study
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.
Read the 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.
- Conditions
- Balance, Cerebellum
- Being tested
- Balance and Proprioceptive Training
- Keywords
- Balance, Cerebellum, White matter tract, Diffusion Tensor Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and Proprioceptive TrainingBehavioural
- Step-by-step training (5 levels)
- 30 minute per training
- 3 times per week
- Four weeks
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | A single training group Receives: Behavioral: Balance and Proprioceptive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
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.
Measured: Four weeks
Secondary outcomes (2)
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.
Measured: Four weeks
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start24 May 2021
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youngkook Kim, The Catholic University of Korea
- Investigators
- Youngkook Kim, Ph.D., Principal investigator, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934319
- Sponsor's protocol ID
- SC20FISI0152
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31446886Kim 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.
PubMed 29801815Kim 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.
PubMed 30582195
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population
- ClinicalTrials.gov ID
- NCT04934319
- Acronym / sponsor ID
- SC20FISI0152
- Conditions
- Balance, Cerebellum
- Keywords
- Balance, Cerebellum, White matter tract, Diffusion Tensor Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Behavioral: Balance and Proprioceptive TrainingA single training group |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mini-mental state examination >=26
- Independent outdoor ambulator
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance and Proprioceptive Training* Step-by-step training (5 levels) * 30 minute per training * 3 times per week * Four weeks | Behavioural | Balance training |
Primary outcome
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.
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.
2 secondary outcomes
Mean diffusivity of the cerebellar white matter tracts
Time frame: Four weeks
Tract volume of the cerebellar white matter tracts
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 31446886Kim 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.
- Background: PubMed 29801815Kim 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.
- Background: PubMed 30582195Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngkook Kim, Ph.D. principal investigator
Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance and Proprioceptive Training in people with Balance and Cerebellum, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy of the cerebellar white matter tracts (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934319, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.