NCT05024240

Brief Summary

The aim of this study is to describe the interaction of the cognitive and visual-cognitive task with postural stability in patients suffering by cerebellar ataxia. Investigators will measure changes in postural stability parameters and in secondary task performance, which should show the ability of the patients to manage the dualtask situations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 10, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

August 11, 2021

Last Update Submit

August 22, 2021

Conditions

Keywords

StabilityDual TaskCerebellumStroop TestBackward Counting Test

Outcome Measures

Primary Outcomes (3)

  • Centre of pressure - AREA (mm2)

    the area below the graph of the curve formed by the movement of the patient's center of gravity during the 30 seconds while standing on the platform, computer processed (Kistler programme), measured in squared millimeters

    1 week

  • Centre of pressure - LENGHT (mm)

    the length of the curve formed by the movement of the patient's center of gravity during 30 seconds while standing on the platform, computer processed (Kistler programme), measured in millimeters

    1 week

  • Reaction time in secondary tasks (ms)

    time (measured in milliseconds) between individual responses of probands in a cognitive or visual test, measured from an audio recording of proband´s responses using a professional audio editing program

    1 week

Study Arms (2)

Patient group

EXPERIMENTAL

20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor

Diagnostic Test: StabilometryDiagnostic Test: Stroop testDiagnostic Test: Backward counting test

Control group

ACTIVE COMPARATOR

20 healthy age-matching probands without any neurological disorders and stability issues

Diagnostic Test: StabilometryDiagnostic Test: Stroop testDiagnostic Test: Backward counting test

Interventions

StabilometryDIAGNOSTIC_TEST

Probands will stand on stabilometric platform (double leg stance) and we will measure CoP parameters area and length. We also make this task harder by using foam and exclusion of visual control. Length of one test is 30s.

Control groupPatient group
Stroop testDIAGNOSTIC_TEST

There are various names of colours written in non-matching font colour in this test. During this test probands are required to name the colour which is written in text not the colour of the font. We will measure reaction time and number of mistakes.

Control groupPatient group
Backward counting testDIAGNOSTIC_TEST

In this counting test probands are given number from interval \<180-200\> and they are asked to subtract 7 during 30s interval of the testing. We will measure reaction time and number of mistakes.

Also known as: BCT
Control groupPatient group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hz tremor in in frequency analysis (posturografy)
  • stability disorder caused by cerebellar disorders in diagnose

You may not qualify if:

  • lower than high school education
  • vestibular disorders
  • ankle instability
  • other specific stability disorders
  • unability to stand for 30s

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Faculty of Medicine, Charles University

Prague, 15006, Czechia

Location

MeSH Terms

Conditions

Cerebellar AtaxiaCerebellar Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pavel Kolář, Prof. PaedDr. Ph.D.

    Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University

    STUDY CHAIR
  • Ondřej Čakrt, Doc. PhDr. Ph.D.

    Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University

    STUDY DIRECTOR
  • Kateřina Levínská, Mgr.

    Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: There will be group of patients with disorders od cerebellum and control group of healthy age-matching probands
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 27, 2021

Study Start

October 10, 2018

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations