Cerebellar AtaxiaNCT05024240
Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders
A study testing Stabilometry, Stroop test and Backward counting test in people with Cerebellar Ataxia and Cerebellar Diseases, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Ataxia, Cerebellar Diseases
- What is being tested?
- Stabilometry, Stroop test and Backward counting test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Oct 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 3 Hz tremor in in frequency analysis (posturografy)
- stability disorder caused by cerebellar disorders in diagnose
Who cannot join
- lower than high school education
- vestibular disorders
- ankle instability
- other specific stability disorders
- unability to stand for 30s
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Cerebellar Ataxia, Cerebellar Diseases
- Being tested
- Stabilometry, Stroop test, Backward counting test
- Keywords
- Stability, Dual Task, Cerebellum, Stroop Test, Backward Counting Test
- Medical subject headings
- Cerebellar Ataxia, Cerebellar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Backward counting testDiagnostic test
Also called BCT
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | 20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor Receives: Diagnostic Test: Stabilometry; Diagnostic Test: Stroop test; Diagnostic Test: Backward counting test |
| Control group | Active comparator | 20 healthy age-matching probands without any neurological disorders and stability issues Receives: Diagnostic Test: Stabilometry; Diagnostic Test: Stroop test; Diagnostic Test: Backward counting test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start10 Oct 2018
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be group of patients with disorders od cerebellum and control group of healthy age-matching probands
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mgr. Kateřina Levínská, Charles University, Czech Republic
- Investigators
- Pavel Kolář, Prof. PaedDr. Ph.D., Study chair, Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles UniversityOndřej Čakrt, Doc. PhDr. Ph.D., Study director, Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles UniversityKateřina Levínská, Mgr., Principal investigator, Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024240
- Sponsor's protocol ID
- ID 14827
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders Based on Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT05024240
- Acronym / sponsor ID
- ID 14827
- Conditions
- Cerebellar Ataxia, Cerebellar Diseases
- Keywords
- Stability, Dual Task, Cerebellum, Stroop Test, Backward Counting Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be group of patients with disorders od cerebellum and control group of healthy age-matching probands
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Diagnostic Test: Stabilometry, Diagnostic Test: Stroop test, Diagnostic Test: Backward counting test20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor |
| Control group | Active comparator | Diagnostic Test: Stabilometry, Diagnostic Test: Stroop test, Diagnostic Test: Backward counting test20 healthy age-matching probands without any neurological disorders and stability issues |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 3 Hz tremor in in frequency analysis (posturografy)
- stability disorder caused by cerebellar disorders in diagnose
Key exclusion criteria (5 listed)
- lower than high school education
- vestibular disorders
- ankle instability
- other specific stability disorders
- unability to stand for 30s
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StabilometryProbands 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 | Control group, Patient group |
| Stroop testThere 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 | Control group, Patient group |
| Backward counting testAlso: BCTIn 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. | Diagnostic test | Control group, Patient group |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Kolář, Prof. PaedDr. Ph.D. study chair
Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Ondřej Čakrt, Doc. PhDr. Ph.D. study director
Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
Kateřina Levínská, Mgr. principal investigator
Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilometry, Stroop test and Backward counting test in people with Cerebellar Ataxia and Cerebellar Diseases, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Centre of pressure - AREA (mm2) (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.