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

August 22, 2021 updated by: Mgr. Kateřina Levínská, Charles University, Czech Republic

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 15006
        • Second Faculty of Medicine, Charles University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centre of pressure - AREA (mm2)
Time Frame: 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
1 week
Centre of pressure - LENGHT (mm)
Time Frame: 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
1 week
Reaction time in secondary tasks (ms)
Time Frame: 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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 22, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 14827

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebellar Ataxia

Clinical Trials on Stabilometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe