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

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05024240

Collaborator

(none)

Enrollment

Location

Arms

37.7

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebellar Ataxia Cerebellar Diseases	Diagnostic Test: Stabilometry Diagnostic Test: Stroop test Diagnostic Test: Backward counting test	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders Based on Cerebellar Ataxia

Actual Study Start Date :

Oct 10, 2018

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient group 20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor	Diagnostic Test: 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. 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. 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. Other Names: BCT
Active Comparator: Control group 20 healthy age-matching probands without any neurological disorders and stability issues	Diagnostic Test: 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. 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. 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. Other Names: BCT

Arm

Intervention/Treatment

Experimental: Patient group

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

Diagnostic Test: 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.

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.

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.

Other Names:

BCT

Active Comparator: Control group

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

Diagnostic Test: Stabilometry

Diagnostic Test: Stroop test

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.

Other Names:

BCT

Outcome Measures

Primary Outcome Measures

Centre of pressure - AREA (mm2) [1 week]
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
Centre of pressure - LENGHT (mm) [1 week]
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
Reaction time in secondary tasks (ms) [1 week]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Faculty of Medicine, Charles University	Prague		Czechia	15006

Sponsors and Collaborators

Charles University, Czech Republic

Investigators

Study Chair: Pavel Kolář, Prof. PaedDr. Ph.D., Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Study Director: Ondřej Čakrt, Doc. PhDr. Ph.D., Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Principal Investigator: Kateřina Levínská, Mgr., Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University