- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474209
Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis (TaiChi-SM)
The Combined Impact of a Structured Tai Chi Exercise Program on Selected Clinical Aspects and Quality of Life of Patients With Multiple Sclerosis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Slovak Republic
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Bratislava, Slovak Republic, Slovakia, 83305
- 2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinically defined MS,
- age from 20 to 60 years,
- and the ability to stand and walk independently at least 200 meters without an assistive device.
Exclusion Criteria:
- clinical MS exacerbation during the study,
- disease-modifying drug change during the study,
- pregnancy,
- involvement in any other exercise programme,
- severe cognitive deficit (defined by Montreal Cognitive Assessment score ≤19), and
- any other health condition that would interfere with an exercise programme (such as musculoskeletal disorder, lung, or heart disease).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: exercise patients with multiple sclerosis
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.
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"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes for 12 months
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No Intervention: non-exercising patients with multiple sclerosis
the group will be a control group, patients with multiple sclerosis undergo a whole battery of examinations and scales, they will not undergo exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
V0 visit- Static posturography
Time Frame: 1. day
|
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
1. day
|
V1 visit- Static posturography
Time Frame: 3 months after V0 visit
|
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
3 months after V0 visit
|
V2 visit- Static posturography
Time Frame: 6 months after V0 visit
|
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
6 months after V0 visit
|
V3 visit- Static posturography
Time Frame: 9 months after V0 visit
|
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
9 months after V0 visit
|
V4 visit- Static posturography
Time Frame: 12 months after V0 visit
|
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
12 months after V0 visit
|
V0 visit- Static posturography LI
Time Frame: 1. day
|
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
1. day
|
V1 visit- Static posturography LI
Time Frame: 3 months after V0 visit
|
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
3 months after V0 visit
|
V2 visit- Static posturography LI
Time Frame: 6 months after V0 visit
|
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
6 months after V0 visit
|
V3 visit- Static posturography LI
Time Frame: 9 months after V0 visit
|
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
9 months after V0 visit
|
V4 visit- Static posturography LI
Time Frame: 12 months after V0 visit
|
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
12 months after V0 visit
|
V0 visit- Static posturography TA
Time Frame: 1. day
|
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
1. day
|
V1 visit- Static posturography TA
Time Frame: 3 months after V0 visit
|
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
3 months after V0 visit
|
V2 visit- Static posturography TA
Time Frame: 6 months after V0 visit
|
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
6 months after V0 visit
|
V3 visit- Static posturography TA
Time Frame: 9 months after V0 visit
|
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
9 months after V0 visit
|
V4 visit- Static posturography TA
Time Frame: 12 months after V0 visit
|
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
|
12 months after V0 visit
|
V0 visit- Static posturography RMS
Time Frame: 1. day
|
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
1. day
|
V1 visit- Static posturography RMS
Time Frame: 3 months after V0 visit
|
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
3 months after V0 visit
|
V2 visit- Static posturography RMS
Time Frame: 6 months after V0 visit
|
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
6 months after V0 visit
|
V3 visit- Static posturography RMS
Time Frame: 9 months after V0 visit
|
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
9 months after V0 visit
|
V4 visit- Static posturography RMS
Time Frame: 12 months after V0 visit
|
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
|
12 months after V0 visit
|
V0 visit- Mini-BESTest
Time Frame: 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. |
1. day
|
V1 visit- Mini-BESTest
Time Frame: 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. |
3 months after V0 visit
|
V2 visit- Mini-BESTest
Time Frame: 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. |
6 months after V0 visit
|
V3 visit- Mini-BESTest
Time Frame: 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. |
9 months after V0 visit
|
V4 visit- Mini-BESTest
Time Frame: 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. |
12 months after V0 visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
V0 visit- EDSS - Expanded disability status scale
Time Frame: 1. day
|
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
|
1. day
|
V1 visit- EDSS - Expanded disability status scale
Time Frame: 3 months after V0 visit
|
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
|
3 months after V0 visit
|
V2 visit- EDSS - Expanded disability status scale
Time Frame: 6 months after V0 visit
|
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
|
6 months after V0 visit
|
V3 visit- EDSS - Expanded disability status scale
Time Frame: 9 months after V0 visit
|
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
|
9 months after V0 visit
|
V4 visit- EDSS - Expanded disability status scale
Time Frame: 12 months after V0 visit
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EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
|
12 months after V0 visit
|
V0 visit- T25FW - Timed 25-foot walk test
Time Frame: 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. |
1. day
|
V1 visit- T25FW - Timed 25-foot walk test
Time Frame: 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. |
3 months after V0 visit
|
V2 visit- T25FW - Timed 25-foot walk test
Time Frame: 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. |
6 months after V0 visit
|
V3 visit- T25FW - Timed 25-foot walk test
Time Frame: 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. |
9 months after V0 visit
|
V4 visit- T25FW - Timed 25-foot walk test
Time Frame: 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. |
12 months after V0 visit
|
V0 visit- PASAT - Paced Auditory Serial Addition
Time Frame: 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. |
1. day
|
V1 visit- PASAT - Paced Auditory Serial Addition
Time Frame: 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. |
3 months after V0 visit
|
V2 visit- PASAT - Paced Auditory Serial Addition
Time Frame: 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. |
6 months after V0 visit
|
V3 visit- PASAT - Paced Auditory Serial Addition
Time Frame: 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. |
9 months after V0 visit
|
V4 visit- PASAT - Paced Auditory Serial Addition
Time Frame: 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. |
12 months after V0 visit
|
V0 visit- SDMT - Symbol Digit Modalities Test
Time Frame: 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. |
1. day
|
V1 visit- SDMT - Symbol Digit Modalities Test
Time Frame: 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. |
3 months after V0 visit
|
V2 visit- SDMT - Symbol Digit Modalities Test
Time Frame: 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. |
6 months after V0 visit
|
V3 visit- SDMT - Symbol Digit Modalities Test
Time Frame: 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. |
9 months after V0 visit
|
V4 visit- SDMT - Symbol Digit Modalities Test
Time Frame: 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. |
12 months after V0 visit
|
V0 visit- EQ-5D - European Quality of Life Questionnaire
Time Frame: 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.
|
1. day
|
V1 visit- EQ-5D - European Quality of Life Questionnaire
Time Frame: 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.
|
3 months after V0 visit
|
V2 visit- EQ-5D - European Quality of Life Questionnaire
Time Frame: 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.
|
6 months after V0 visit
|
V3 visit- EQ-5D - European Quality of Life Questionnaire
Time Frame: 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.
|
9 months after V0 visit
|
V4 visit- EQ-5D - European Quality of Life Questionnaire
Time Frame: 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.
|
12 months after V0 visit
|
V0 visit- FES - Falls Efficacy Scale
Time Frame: 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.
|
1. day
|
V1 visit- FES - Falls Efficacy Scale
Time Frame: 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.
|
3 months after V0 visit
|
V2 visit- FES - Falls Efficacy Scale
Time Frame: 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.
|
6 months after V0 visit
|
V3 visit- FES - Falls Efficacy Scale
Time Frame: 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.
|
9 months after V0 visit
|
V4 visit- FES - Falls Efficacy Scale
Time Frame: 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.
|
12 months after V0 visit
|
V0 visit- ABC - Activities-Specific Balance Confidence Scale
Time Frame: 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
|
1. day
|
V1 visit- ABC - Activities-Specific Balance Confidence Scale
Time Frame: 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
|
3 months after V0 visit
|
V2 visit- ABC - Activities-Specific Balance Confidence Scale
Time Frame: 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
|
6 months after V0 visit
|
V3 visit- ABC - Activities-Specific Balance Confidence Scale
Time Frame: 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
|
9 months after V0 visit
|
V4 visit- ABC - Activities-Specific Balance Confidence Scale
Time Frame: 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
|
12 months after V0 visit
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V0 visit- BDI-II - The Beck Depression Inventory
Time Frame: 1. day
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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
|
1. day
|
V1 visit- BDI-II - The Beck Depression Inventory
Time Frame: 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
|
3 months after V0 visit
|
V2 visit- BDI-II - The Beck Depression Inventory
Time Frame: 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
|
6 months after V0 visit
|
V3 visit- BDI-II - The Beck Depression Inventory
Time Frame: 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
|
9 months after V0 visit
|
V4 visit- BDI-II - The Beck Depression Inventory
Time Frame: 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
|
12 months after V0 visit
|
V0 visit- BAI - The Beck Anxiety Inventory
Time Frame: 1. day
|
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
|
1. day
|
V1 visit- BAI - The Beck Anxiety Inventory
Time Frame: 3 months after V0 visit
|
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
|
3 months after V0 visit
|
V2 visit- BAI - The Beck Anxiety Inventory
Time Frame: 6 months after V0 visit
|
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
|
6 months after V0 visit
|
V3 visit- BAI - The Beck Anxiety Inventory
Time Frame: 9 months after V0 visit
|
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
|
9 months after V0 visit
|
V4 visit- BAI - The Beck Anxiety Inventory
Time Frame: 12 months after V0 visit
|
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
|
12 months after V0 visit
|
V0 visit- MoCA - Montreal cognitive assessment
Time Frame: 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. |
1. day
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V1 visit- MoCA - Montreal cognitive assessment
Time Frame: 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. |
3 months after V0 visit
|
V2 visit- MoCA - Montreal cognitive assessment
Time Frame: 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. |
6 months after V0 visit
|
V3 visit- MoCA - Montreal cognitive assessment
Time Frame: 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. |
9 months after V0 visit
|
V4 visit- MoCA - Montreal cognitive assessment
Time Frame: 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. |
12 months after V0 visit
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Peter Valkovič, prof.MD.PhD., 2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA
Publications and helpful links
General Publications
- Gibson JC, Summers GD. Bone health in multiple sclerosis. Osteoporos Int. 2011 Dec;22(12):2935-49. doi: 10.1007/s00198-011-1644-8. Epub 2011 May 21. Review.
- Arnett PA, Strober LB. Cognitive and neurobehavioral features in multiple sclerosis. Expert Rev Neurother. 2011 Mar;11(3):411-24. doi: 10.1586/ern.11.12. Review.
- Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
- Alvarenga-Filho H, Sacramento PM, Ferreira TB, Hygino J, Abreu JEC, Carvalho SR, Wing AC, Alvarenga RMP, Bento CAM. Combined exercise training reduces fatigue and modulates the cytokine profile of T-cells from multiple sclerosis patients in response to neuromediators. J Neuroimmunol. 2016 Apr 15;293:91-99. doi: 10.1016/j.jneuroim.2016.02.014. Epub 2016 Feb 26.
- Wens I, Keytsman C, Deckx N, Cools N, Dalgas U, Eijnde BO. Brain derived neurotrophic factor in multiple sclerosis: effect of 24 weeks endurance and resistance training. Eur J Neurol. 2016 Jun;23(6):1028-35. doi: 10.1111/ene.12976. Epub 2016 Mar 16.
- Husted C, Pham L, Hekking A, Niederman R. Improving quality of life for people with chronic conditions: the example of t'ai chi and multiple sclerosis. Altern Ther Health Med. 1999 Sep;5(5):70-4.
- Azimzadeh E, Hosseini MA, Nourozi K, Davidson PM. Effect of Tai Chi Chuan on balance in women with multiple sclerosis. Complement Ther Clin Pract. 2015 Feb;21(1):57-60. doi: 10.1016/j.ctcp.2014.09.002. Epub 2014 Nov 27.
- Burschka JM, Keune PM, Oy UH, Oschmann P, Kuhn P. Mindfulness-based interventions in multiple sclerosis: beneficial effects of Tai Chi on balance, coordination, fatigue and depression. BMC Neurol. 2014 Aug 23;14:165. doi: 10.1186/s12883-014-0165-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/0130/2020/UNBKramare
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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