Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders

NCT ID: NCT05024240

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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The aim of this research will be to describe the interaction between cognitive and cognitive sensory tasks and stability in patients whose disease impairs the ability to maintain a stable upright position, for example in patients with cerebellar syndromes. And further compare this interaction with a control group of healthy probands. This interaction will be investigated in variously demanding postural situations (eg. standing on both lower limbs, with the exclusion of visual control, with reduced proprioceptive input from the patch).

Patient stability will be quantified using a stabilometric examination on the Kistler platform (Kistler Instrumente AG, Switzerland). investigators will quantify the performance of patients in secondary tasks using parameters such as response time to response and success in assigned tests.

The expected number of probands is 20 individuals in both groups. Study will objectify postural stability by means of a static stabilometric examination on the Kistler platform, the recording length of each postural situation will be 30 s. Four different demands of postural tasks were chosen - a bipedal stand, a bipedal stand with the exclusion of visual control, a stand on a foam pad and a stand on a foam pad with the exclusion of visual control. To evaluate postural deviations, investigators chose the following CoP parameters: stabilogram curve length and stabilogram area. During the stabilometric measurement, the number of touches of the guardrail will also be recorded, or the number of falls or touches with a lightened limb of the pad or the other limb during the measurement. Testing will take place in the Neurological Laboratory of the Department of Neurology, 2nd Faculty of Medicine, Charles University in Prague and FN Motol.

Gradually, two types of secondary task will be added to the postural tasks, with visual input (modified Stroop test) and a purely cognitive task (Backward counting test). At first, probands will be acquainted with what types of tasks await them during the experiment and will be able to train each of them in two trial experiments. This will be followed by testing trials in random order (cognitive tests in single-task situations, namely sitting in a chair, single task postural tasks and dual-task situations).

Conditions

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Cerebellar Ataxia Cerebellar Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be group of patients with disorders od cerebellum and control group of healthy age-matching probands
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patient group

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

Group Type EXPERIMENTAL

Stabilometry

Intervention Type DIAGNOSTIC_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.

Stroop test

Intervention Type DIAGNOSTIC_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.

Backward counting test

Intervention Type DIAGNOSTIC_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.

Control group

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

Group Type ACTIVE_COMPARATOR

Stabilometry

Intervention Type DIAGNOSTIC_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.

Stroop test

Intervention Type DIAGNOSTIC_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.

Backward counting test

Intervention Type DIAGNOSTIC_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.

Interventions

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Stabilometry

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.

Intervention Type DIAGNOSTIC_TEST

Stroop 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.

Intervention Type DIAGNOSTIC_TEST

Backward counting 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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BCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* lower than high school education
* vestibular disorders
* ankle instability
* other specific stability disorders
* unability to stand for 30s
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Mgr. Kateřina Levínská

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pavel Kolář, Prof. PaedDr. Ph.D.

Role: STUDY_CHAIR

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

Ondřej Čakrt, Doc. PhDr. Ph.D.

Role: STUDY_DIRECTOR

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

Kateřina Levínská, Mgr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Second Faculty of Medicine, Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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ID 14827

Identifier Type: -

Identifier Source: org_study_id

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