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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Art for MS - Controlled Trial

Clinicaltrials.gov identifier NCT03938558

Recruitment Status Completed

First Posted May 6, 2019

Last update posted June 1, 2020

Study Description

Brief summary:

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?

  • Condition or Disease:Fatigue
    Multiple Sclerosis
  • Intervention/Treatment: Other: MS-Dance
    Other: MS-Art
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 17 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: 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.
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official 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
  • Actual Study Start Date: August 2018
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: April 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Dance intervention group
Dancers at beginners level Dancers at advanced level
Other: MS-Dance
The experimental group will perform 10 weeks of dance training
Active Comparator: Art intervention group
Paint artists Word artists Film artists Photographers
Other: MS-Art
The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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)

Contacts and Locations
Contacts
Locations

Belgium
Hasselt University
Hasselt

Sponsors and Collaborators

Hasselt University

Investigators

Principal Investigator: peter Feys, prof. dr. Hasselt University

Study Chair: Fanny Van Geel, drs. Hasselt University

More Information
  • Responsible Party: Hasselt University
  • ClinicalTrials.gov Identifier: NCT03938558 History of Changes
  • Other Study ID Numbers: B9115201836892
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: June 1, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Hasselt University: multiple sclerosis fatigue
  • Additional relevant MeSH terms: Multiple Sclerosis
    Sclerosis
    Fatigue