Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2018
CompletedFirst Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 27, 2021
August 1, 2021
2.9 years
August 11, 2021
August 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
1 week
Study Arms (2)
Patient group
EXPERIMENTAL20 patients with cerebellum disorders, who suffer from stability disorders and with specific 3 Hz tremor
Control group
ACTIVE COMPARATOR20 healthy age-matching probands without any neurological disorders and stability issues
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Hz tremor in in frequency analysis (posturografy)
- stability disorder caused by cerebellar disorders in diagnose
You may not qualify if:
- lower than high school education
- vestibular disorders
- ankle instability
- other specific stability disorders
- unability to stand for 30s
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Faculty of Medicine, Charles University
Prague, 15006, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 27, 2021
Study Start
October 10, 2018
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
August 27, 2021
Record last verified: 2021-08