Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes

• Registration Number: NCT05474209
• Lead Sponsor: Comenius University

Brief Summary

Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system (CNS). The clinical picture is very variable, ultimately resulting in disability. Disease attacks manifest themselves depending on the location of the CNS damaged by inflammation, demyelination, axonal loss and gliosis. The most common manifestations include motor disorders with the development of stiffness, balance and coordination, cognition, fatigue and depression. In the long term, most patients with MS will achieve significant and irreversible incapacitation. Immunomodulatory therapy is designed to reduce disease activity, slowing progression, but only to a certain extent. A significant benefit, but little researched, is physical exercise. Tai Chi has a positive effect on various neurological diseases. In recent studies, Tai Chi has shown improvements in coordination and balance, depression, anxiety, cognition and overall quality of life in patients with MS. The aim of the project is to assess the therapeutic value of structured Tai Chi exercise based on published clinical work.

Detailed Description

Multiple sclerosis (MS) is a chronic disease that mainly affects young people with a maximum incidence in working age. Demyelination, axial damage, inflammation and gliosis affect the brain, spinal cord and optic nerves. The resulting symptoms are both physical and mental, and are closely related. The degree of disability in MS can range from relatively benign to malignant forms leading to severe disability in patients over several years. The most common symptoms of MS are impaired motor and sensitive functions, imbalances and coordination. Loss of balance leads to falls, in patients with MS they occur with a prevalence of 34-64%. The result is injuries, fractures, soft tissue damage, restricted activities and reduced mobility. The psychological aspect is loss of independence, social isolation, reduced quality of life. The clinical picture of MS also includes cognitive dysfunction (more than half of patients with MS) and a number of neurobehavioral disorders, especially fatigue (53-90%), depression (with a prevalence of 40-60%), anxiety disorders (35%). They are conditioned not only by reactivity, but indeed by the pathophysiology of the disease itself. Cognitive and affective symptoms associated with MS are a serious psychosocial factor limiting the course of the disease. MS is an incurable disease. Immunomodulatory therapy, which is continuously modified according to the patient's condition, is essentially a variety of effective prevention of progression of disability. At present, there is not enough knowledge about the right combination and structure of programmed physical exercise, which would significantly alleviate the symptoms of MS. While in the past it has not been recommended to patients in the traditional sense of MS, recent findings integrate physical exercise into the treatment of MS as an essential component. Current research points to significant benefits of physical activity in patients with MS: improved aerobic capacity and muscle strength, mobility, fatigue, and quality of life. Even the potential of physical exercise for the pathology of SM itself is expected, namely anti-inflammatory - by modulating the cytokine profile of T-cells and neuroprotective - by increasing the level of serum BDNF (brain-derived neurotrophic factor). Tai Chi Chuan - The inner art of Taoist Tai Chi is not practiced as a martial art technique or in a competitive spirit. A characteristic feature of Tai Chi is stretching and rotation in every movement. Another aspect is the emphasis on sitting and getting up, which helps to improve balance, strengthen legs, tendons and ligaments. Tai Chi also has a spiritual dimension associated with physical exercise. The primary goal is relaxation of body and soul, for Tai Chi are characterized by slow and controlled movements, deep relaxed breathing and correct posture through a state of awareness and concentration. Tai Chi improves flexibility, range of motion, muscle strength and balance and therefore could be beneficial for MS patients. As many of the basic principles of Tai Chi are directly related to postural control, initial smaller studies have begun to show that improvements in depression, quality of life and balance have improved.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-31
• Study Completion: 2022-01-31
• Study First Submitted: 2022-06-16
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. clinically defined MS,
2. age from 20 to 60 years,
3. and the ability to stand and walk independently at least 200 meters without an assistive device.

Exclusion Criteria

1. clinical MS exacerbation during the study,
2. disease-modifying drug change during the study,
3. pregnancy,
4. involvement in any other exercise programme,
5. severe cognitive deficit (defined by Montreal Cognitive Assessment score ≤19), and
6. any other health condition that would interfere with an exercise programme (such as musculoskeletal disorder, lung, or heart disease).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise patients with multiple sclerosis	"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes	a group that undergoes a "tai-chi" intervention - a special program for patients with multiple sclerosis - once a week with a Tai Chi instructor lasting 90 minutes. At V0, each patient will receive an accurate instructional video for a separate home exercise "tai-chi" at an intensity of twice a week.

Primary Outcome Measures

Name	Time	Method
V0 visit- Static posturography	1. day	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography	6 months after V0 visit	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography	12 months after V0 visit	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography LI	9 months after V0 visit	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Static posturography TA	1. day	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography TA	3 months after V0 visit	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography TA	12 months after V0 visit	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography RMS	3 months after V0 visit	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography RMS	6 months after V0 visit	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography	9 months after V0 visit	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Static posturography LI	1. day	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Static posturography RMS	1. day	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography	3 months after V0 visit	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography LI	6 months after V0 visit	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography LI	12 months after V0 visit	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography TA	6 months after V0 visit	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography RMS	9 months after V0 visit	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Mini-BESTest	9 months after V0 visit	Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.; The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.
V4 visit- Mini-BESTest	12 months after V0 visit	Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.; The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.
V1 visit- Static posturography LI	3 months after V0 visit	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography TA	9 months after V0 visit	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Mini-BESTest	1. day	Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.; The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.
V1 visit- Mini-BESTest	3 months after V0 visit	Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.; The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.
V2 visit- Mini-BESTest	6 months after V0 visit	Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.; The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.
V4 visit- Static posturography RMS	12 months after V0 visit	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

Secondary Outcome Measures

Name	Time	Method
V1 visit- EDSS - Expanded disability status scale	3 months after V0 visit	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V2 visit- EDSS - Expanded disability status scale	6 months after V0 visit	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V0 visit- PASAT - Paced Auditory Serial Addition	1. day	PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.; The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.
V0 visit- SDMT - Symbol Digit Modalities Test	1. day	SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.; The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.
V4 visit- SDMT - Symbol Digit Modalities Test	12 months after V0 visit	SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.; The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.
V0 visit- T25FW - Timed 25-foot walk test	1. day	T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.; The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.
V1 visit- T25FW - Timed 25-foot walk test	3 months after V0 visit	T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.; The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.
V3 visit- SDMT - Symbol Digit Modalities Test	9 months after V0 visit	SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.; The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.
V1 visit- EQ-5D - European Quality of Life Questionnaire	3 months after V0 visit	The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.
V0 visit- EDSS - Expanded disability status scale	1. day	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V2 visit- T25FW - Timed 25-foot walk test	6 months after V0 visit	T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.; The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.
V3 visit- T25FW - Timed 25-foot walk test	9 months after V0 visit	T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.; The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.
V4 visit- T25FW - Timed 25-foot walk test	12 months after V0 visit	T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.; The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.
V3 visit- EDSS - Expanded disability status scale	9 months after V0 visit	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V4 visit- EDSS - Expanded disability status scale	12 months after V0 visit	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V4 visit- EQ-5D - European Quality of Life Questionnaire	12 months after V0 visit	The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.
V3 visit- FES - Falls Efficacy Scale	9 months after V0 visit	FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
V3 visit- BAI - The Beck Anxiety Inventory	9 months after V0 visit	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V4 visit- BAI - The Beck Anxiety Inventory	12 months after V0 visit	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V2 visit- MoCA - Montreal cognitive assessment	6 months after V0 visit	MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.; MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.
V1 visit- PASAT - Paced Auditory Serial Addition	3 months after V0 visit	PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.; The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.
V2 visit- SDMT - Symbol Digit Modalities Test	6 months after V0 visit	SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.; The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.
V0 visit- EQ-5D - European Quality of Life Questionnaire	1. day	The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.
V1 visit- FES - Falls Efficacy Scale	3 months after V0 visit	FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
V1 visit- BAI - The Beck Anxiety Inventory	3 months after V0 visit	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V0 visit- MoCA - Montreal cognitive assessment	1. day	MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.; MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.
V1 visit- MoCA - Montreal cognitive assessment	3 months after V0 visit	MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.; MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.
V2 visit- PASAT - Paced Auditory Serial Addition	6 months after V0 visit	PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.; The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.
V3 visit- PASAT - Paced Auditory Serial Addition	9 months after V0 visit	PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.; The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.
V4 visit- PASAT - Paced Auditory Serial Addition	12 months after V0 visit	PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.; The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.
V1 visit- SDMT - Symbol Digit Modalities Test	3 months after V0 visit	SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.; The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.
V2 visit- FES - Falls Efficacy Scale	6 months after V0 visit	FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
V4 visit- FES - Falls Efficacy Scale	12 months after V0 visit	FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
V1 visit- ABC - Activities-Specific Balance Confidence Scale	3 months after V0 visit	ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of \> 80% indicates high level of functioning
V3 visit- ABC - Activities-Specific Balance Confidence Scale	9 months after V0 visit	ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of \> 80% indicates high level of functioning
V4 visit- ABC - Activities-Specific Balance Confidence Scale	12 months after V0 visit	ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of \> 80% indicates high level of functioning
V3 visit- EQ-5D - European Quality of Life Questionnaire	9 months after V0 visit	The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.
V2 visit- ABC - Activities-Specific Balance Confidence Scale	6 months after V0 visit	ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of \> 80% indicates high level of functioning
V0 visit- BDI-II - The Beck Depression Inventory	1. day	BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome
V1 visit- BDI-II - The Beck Depression Inventory	3 months after V0 visit	BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome
V4 visit- BDI-II - The Beck Depression Inventory	12 months after V0 visit	BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome
V0 visit- BAI - The Beck Anxiety Inventory	1. day	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V2 visit- EQ-5D - European Quality of Life Questionnaire	6 months after V0 visit	The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.
V0 visit- FES - Falls Efficacy Scale	1. day	FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
V0 visit- ABC - Activities-Specific Balance Confidence Scale	1. day	ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of \> 80% indicates high level of functioning
V3 visit- BDI-II - The Beck Depression Inventory	9 months after V0 visit	BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome
V2 visit- BDI-II - The Beck Depression Inventory	6 months after V0 visit	BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome
V2 visit- BAI - The Beck Anxiety Inventory	6 months after V0 visit	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V3 visit- MoCA - Montreal cognitive assessment	9 months after V0 visit	MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.; MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.
V4 visit- MoCA - Montreal cognitive assessment	12 months after V0 visit	MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.; MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.

Trial Locations

Locations (1)

2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA; 🇸🇰 Bratislava, Slovak Republic, Slovakia