Art for MS - Controlled Trial

Study Overview
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Brief Summary
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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: Does a multimodal dance intervention have positive effects on walking-related fatigability? Does a multimodal dance intervention have positive effects on other MS symptoms related to fatigue and fatigability?

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Sclerosis, Fatigue

Intervention / Treatment
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* Other: MS-Dance
* Other: MS-Art


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dance intervention group<br>Dancers at beginners level Dancers at advanced level | Other: MS-Dance<br>* The experimental group will perform 10 weeks of dance training<br>|
| Active Comparator: Art intervention group<br>Paint artists Word artists Film artists Photographers | Other: MS-Art<br>* The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor fatigability | 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 | Baseline | 
| motor fatigability | 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 | week 10 | 
| motor fatigability | 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 | week 20 | 
| Trait motor fatigue | Modified Fatigue Impact Scale (MFIS) | baseline | 
| Trait motor fatigue | Modified Fatigue Impact Scale (MFIS) | week 10 | 
| Trait motor fatigue | Modified Fatigue Impact Scale (MFIS) | week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coördination test with lower limbs | 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) | baseline | 
| Coördination test with lower limbs | 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) | week 10 | 
| Coördination test with lower limbs | 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) | week 20 | 
| Perceived motor fatigability | VAS increase minute per minute during 6MWT (range 0-10) | Baseline | 
| Perceived motor fatigability | VAS increase minute per minute during 6MWT (range 0-10) | week 10 | 
| Perceived motor fatigability | VAS increase minute per minute during 6MWT (range 0-10) | week 20 | 
| Performance cognitive fatigability and cognitive capacity | PASAT and SDMT total score and correct answers last ⅓ vs first ⅓ | Baseline | 
| Performance cognitive fatigability and cognitive capacity | PASAT and SDMT total score and correct answers last ⅓ vs first ⅓ | week 10 | 
| Performance cognitive fatigability and cognitive capacity | PASAT and SDMT total score and correct answers last ⅓ vs first ⅓ | week 20 | 
| Trait fatigue | Fatigue Severity Scale (FSS) : range 1-7 | Baseline | 
| Trait fatigue | Fatigue Severity Scale (FSS) : range 1-7 | week 10 | 
| Trait fatigue | Fatigue Severity Scale (FSS) : range 1-7 | week 20 | 
| MSIS-29 Questionnaire | Impact of MS via a questionnaire. 29 items, total score on 145. | Baseline | 
| MSIS-29 Questionnaire | Impact of MS via a questionnaire. 29 items, total score on 145. | week 10 | 
| MSIS-29 Questionnaire | Impact of MS via a questionnaire. 29 items, total score on 145. | week 20 | 
| SF-36 Questionnaire | Quality of Life health related questionnaire. Scale 0-100 | Baseline | 
| SF-36 Questionnaire | Quality of Life health related questionnaire. Scale 0-100 | week 10 | 
| SF-36 Questionnaire | Quality of Life health related questionnaire. Scale 0-100 | week 20 | 
| ABC scale | Activity balance confidence scale. Scale has 16 items and is transferred to a percentage. | Baseline | 
| ABC scale | Activity balance confidence scale. Scale has 16 items and is transferred to a percentage. | week 10 | 
| ABC scale | Activity balance confidence scale. Scale has 16 items and is transferred to a percentage. | week 20 | 
| MSWS-12 Questionnaire | Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12. | Baseline | 
| MSWS-12 Questionnaire | Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12. | week 10 | 
| MSWS-12 Questionnaire | Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12. | week 20 | 
| 5xSTS T25FW | 5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds | Baseline | 
| 5xSTS T25FW | 5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds | week 10 | 
| 5xSTS T25FW | 5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds | week 20 | 
| T25FW test | patients have to walk 25 feet as fast as possible. Determined in seconds | Baseline | 
| T25FW test | patients have to walk 25 feet as fast as possible. Determined in seconds | week 10 | 
| T25FW test | patients have to walk 25 feet as fast as possible. Determined in seconds | week 20 | 
| NHPT (Nine hole peck test) | Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds. | Baseline | 
| NHPT (Nine hole peck test) | Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds. | week 10 | 
| NHPT (Nine hole peck test) | Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds. | week 20 | 
| DGI (Dynamic gait index) | 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 | Baseline | 
| DGI (Dynamic gait index) | 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 | week 10 | 
| DGI (Dynamic gait index) | 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 | week 20 | 
| EmNSA | 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 | Baseline | 
| EmNSA | 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 | week 10 | 
| EmNSA | 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 | week 20 | 
| CMI (Cognitive motor interference) | 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. | Baseline | 
| CMI (Cognitive motor interference) | 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. | week 10 | 
| CMI (Cognitive motor interference) | 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. | week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, fatigue