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Completed

NCT Number: NCT03938558

Art for MS - Controlled Trial

This study is a controlled pilot study with 17 participants with Multiple Sclerosis (MS). The primary goal of this study is to objectively examine the effects of a multimodal dance intervention on walking-related performance fatigability. The secondary aim is to investigate the effects of a multimodal dance intervention on other MS symptoms related to fatigue and fatigability.

The following research questions will be addressed:

1. Does a multimodal dance intervention have positive effects on walking-related fatigability? 2. Does a multimodal dance intervention have positive effects on other MS symptoms related to fatigue and fatigability?

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Hasselt, 3500, Belgium

About this study

This study distinguish two groups contributing to a dance and art production. The experimental group will perform 10 weeks of dance training, while the other group will contribute to the production in various ways (e.g. word art, photography, painting, …).

Measures will be taken before and after the training or assistance in the production.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 - 70 years
  • Confirmed diagnosis according to the McDonald criteria
  • Able to walk independently or with bilateral support for 6 minutes
  • Signed the informed consent

Exclusion criteria

  • Exacerbation or relapse within last 3 months before onset study
  • Other medical conditions interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis, fibromyalgia, Parkinson and stroke)

Treatment and study plan

MS-Dance

Other

The experimental group will perform 10 weeks of dance training

MS-Art

Other

The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)

Primary outcomes

  1. motor fatigability

    Time frame: Baseline

    Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT.

    Formula for walking-related performance fatigability: DWI = ([Distance walked at minute 6 - Distance walked at minute 1]/Distance walked at minute 1) × 100

  2. motor fatigability

    Time frame: week 10

    Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT.

    Formula for walking-related performance fatigability: DWI = ([Distance walked at minute 6 - Distance walked at minute 1]/Distance walked at minute 1) × 100

  3. motor fatigability

    Time frame: week 20

    Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT.

    Formula for walking-related performance fatigability: DWI = ([Distance walked at minute 6 - Distance walked at minute 1]/Distance walked at minute 1) × 100

  4. Trait motor fatigue

    Time frame: baseline

    Modified Fatigue Impact Scale (MFIS)

  5. Trait motor fatigue

    Time frame: week 10

    Modified Fatigue Impact Scale (MFIS)

  6. Trait motor fatigue

    Time frame: week 20

    Modified Fatigue Impact Scale (MFIS)

Secondary outcomes

  1. Coördination test with lower limbs

    Time frame: baseline

    seated bipedal coordination task (knee flexion and extension movements during 6 minutes, and metronome based 0,75 Hz, 1Hz and 1,5 Hz for 1 minute)

  2. Coördination test with lower limbs

    Time frame: week 10

    seated bipedal coordination task (knee flexion and extension movements during 6 minutes, and metronome based 0,75 Hz, 1Hz and 1,5 Hz for 1 minute)

  3. Coördination test with lower limbs

    Time frame: week 20

    seated bipedal coordination task (knee flexion and extension movements during 6 minutes, and metronome based 0,75 Hz, 1Hz and 1,5 Hz for 1 minute)

  4. Perceived motor fatigability

    Time frame: Baseline

    VAS increase minute per minute during 6MWT (range 0-10)

  5. Perceived motor fatigability

    Time frame: week 10

    VAS increase minute per minute during 6MWT (range 0-10)

  6. Perceived motor fatigability

    Time frame: week 20

    VAS increase minute per minute during 6MWT (range 0-10)

  7. Performance cognitive fatigability and cognitive capacity

    Time frame: Baseline

    PASAT and SDMT total score and correct answers last ⅓ vs first ⅓

  8. Performance cognitive fatigability and cognitive capacity

    Time frame: week 10

    PASAT and SDMT total score and correct answers last ⅓ vs first ⅓

  9. Performance cognitive fatigability and cognitive capacity

    Time frame: week 20

    PASAT and SDMT total score and correct answers last ⅓ vs first ⅓

  10. Trait fatigue

    Time frame: Baseline

    Fatigue Severity Scale (FSS) : range 1-7

  11. Trait fatigue

    Time frame: week 10

    Fatigue Severity Scale (FSS) : range 1-7

  12. Trait fatigue

    Time frame: week 20

    Fatigue Severity Scale (FSS) : range 1-7

  13. MSIS-29 Questionnaire

    Time frame: Baseline

    Impact of MS via a questionnaire. 29 items, total score on 145.

  14. MSIS-29 Questionnaire

    Time frame: week 10

    Impact of MS via a questionnaire. 29 items, total score on 145.

  15. MSIS-29 Questionnaire

    Time frame: week 20

    Impact of MS via a questionnaire. 29 items, total score on 145.

  16. SF-36 Questionnaire

    Time frame: Baseline

    Quality of Life health related questionnaire. Scale 0-100

  17. SF-36 Questionnaire

    Time frame: week 10

    Quality of Life health related questionnaire. Scale 0-100

  18. SF-36 Questionnaire

    Time frame: week 20

    Quality of Life health related questionnaire. Scale 0-100

  19. ABC scale

    Time frame: Baseline

    Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.

  20. ABC scale

    Time frame: week 10

    Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.

  21. ABC scale

    Time frame: week 20

    Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.

  22. MSWS-12 Questionnaire

    Time frame: Baseline

    Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.

  23. MSWS-12 Questionnaire

    Time frame: week 10

    Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.

  24. MSWS-12 Questionnaire

    Time frame: week 20

    Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.

  25. 5xSTS T25FW

    Time frame: Baseline

    5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds

  26. 5xSTS T25FW

    Time frame: week 10

    5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds

  27. 5xSTS T25FW

    Time frame: week 20

    5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds

  28. T25FW test

    Time frame: Baseline

    patients have to walk 25 feet as fast as possible. Determined in seconds

  29. T25FW test

    Time frame: week 10

    patients have to walk 25 feet as fast as possible. Determined in seconds

  30. T25FW test

    Time frame: week 20

    patients have to walk 25 feet as fast as possible. Determined in seconds

  31. NHPT (Nine hole peck test)

    Time frame: Baseline

    Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.

  32. NHPT (Nine hole peck test)

    Time frame: week 10

    Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.

  33. NHPT (Nine hole peck test)

    Time frame: week 20

    Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.

  34. DGI (Dynamic gait index)

    Time frame: Baseline

    patient have to perform several static and dynamic balance test. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24

  35. DGI (Dynamic gait index)

    Time frame: week 10

    patient have to perform several static and dynamic balance test. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24

  36. DGI (Dynamic gait index)

    Time frame: week 20

    patient have to perform several static and dynamic balance test. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24

  37. EmNSA

    Time frame: Baseline

    Dynamic gait index: patient have to perform several static and dynamic balance test. A ordinal scale, ranging from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 48

  38. EmNSA

    Time frame: week 10

    Dynamic gait index: patient have to perform several static and dynamic balance test. A ordinal scale, ranging from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 48

  39. EmNSA

    Time frame: week 20

    Dynamic gait index: patient have to perform several static and dynamic balance test. A ordinal scale, ranging from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 48

  40. CMI (Cognitive motor interference)

    Time frame: Baseline

    Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.

    Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.

  41. CMI (Cognitive motor interference)

    Time frame: week 10

    Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.

    Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.

  42. CMI (Cognitive motor interference)

    Time frame: week 20

    Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.

    Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

Art for MS - Effects of a 10 Week Multimodal Dance and Art Intervention Program on Fatigue, Fatigability, and Their Related Factors - A Controlled Pilot-trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2019
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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