Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders
Primary Purpose
Cerebellar Ataxia, Cerebellar Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Stabilometry
Stroop test
Backward counting test
Sponsored by
About this trial
This is an interventional screening trial for Cerebellar Ataxia focused on measuring Stability, Dual Task, Cerebellum, Stroop Test, Backward Counting Test
Eligibility Criteria
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
Sites / Locations
- Second Faculty of Medicine, Charles University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patient group
Control group
Arm Description
20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor
20 healthy age-matching probands without any neurological disorders and stability issues
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05024240
First Posted
August 11, 2021
Last Updated
August 22, 2021
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT05024240
Brief Title
Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders
Official Title
Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders Based on Cerebellar Ataxia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia, Cerebellar Diseases
Keywords
Stability, Dual Task, Cerebellum, Stroop Test, Backward Counting Test
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be group of patients with disorders od cerebellum and control group of healthy age-matching probands
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Experimental
Arm Description
20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
20 healthy age-matching probands without any neurological disorders and stability issues
Intervention Type
Diagnostic Test
Intervention Name(s)
Stabilometry
Intervention Description
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
Intervention Name(s)
Stroop test
Intervention Description
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
Intervention Name(s)
Backward counting test
Other Intervention Name(s)
BCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Centre of pressure - AREA (mm2)
Description
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
Time Frame
1 week
Title
Centre of pressure - LENGHT (mm)
Description
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
Time Frame
1 week
Title
Reaction time in secondary tasks (ms)
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Kolář, Prof. PaedDr. Ph.D.
Organizational Affiliation
Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ondřej Čakrt, Doc. PhDr. Ph.D.
Organizational Affiliation
Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kateřina Levínská, Mgr.
Organizational Affiliation
Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Faculty of Medicine, Charles University
City
Prague
ZIP/Postal Code
15006
Country
Czechia
12. IPD Sharing Statement
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Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders
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