Clinical trial NCT03938558: Art for MS - Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Keywords: multiple sclerosis
fatigue
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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?

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.

Eligibility 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)

Primary outcomes:
measure: motor fatigability
timeFrame: Baseline
measure: motor fatigability
timeFrame: week 10
measure: motor fatigability
timeFrame: week 20
measure: Trait motor fatigue
timeFrame: baseline
measure: Trait motor fatigue
timeFrame: week 10
measure: Trait motor fatigue
timeFrame: week 20
Secondary outcomes:
measure: Coördination test with lower limbs
timeFrame: baseline
measure: Coördination test with lower limbs
timeFrame: week 10
measure: Coördination test with lower limbs
timeFrame: week 20
measure: Perceived motor fatigability
timeFrame: Baseline
measure: Perceived motor fatigability
timeFrame: week 10
measure: Perceived motor fatigability
timeFrame: week 20
measure: Performance cognitive fatigability and cognitive capacity
timeFrame: Baseline
measure: Performance cognitive fatigability and cognitive capacity
timeFrame: week 10
measure: Performance cognitive fatigability and cognitive capacity
timeFrame: week 20
measure: Trait fatigue
timeFrame: Baseline
measure: Trait fatigue
timeFrame: week 10
measure: Trait fatigue
timeFrame: week 20
measure: MSIS-29 Questionnaire
timeFrame: Baseline
measure: MSIS-29 Questionnaire
timeFrame: week 10
measure: MSIS-29 Questionnaire
timeFrame: week 20
measure: SF-36 Questionnaire
timeFrame: Baseline
measure: SF-36 Questionnaire
timeFrame: week 10
measure: SF-36 Questionnaire
timeFrame: week 20
measure: ABC scale
timeFrame: Baseline
measure: ABC scale
timeFrame: week 10
measure: ABC scale
timeFrame: week 20
measure: MSWS-12 Questionnaire
timeFrame: Baseline
measure: MSWS-12 Questionnaire
timeFrame: week 10
measure: MSWS-12 Questionnaire
timeFrame: week 20
measure: 5xSTS T25FW
timeFrame: Baseline
measure: 5xSTS T25FW
timeFrame: week 10
measure: 5xSTS T25FW
timeFrame: week 20
measure: T25FW test
timeFrame: Baseline
measure: T25FW test
timeFrame: week 10
measure: T25FW test
timeFrame: week 20
measure: NHPT (Nine hole peck test)
timeFrame: Baseline
measure: NHPT (Nine hole peck test)
timeFrame: week 10
measure: NHPT (Nine hole peck test)
timeFrame: week 20
measure: DGI (Dynamic gait index)
timeFrame: Baseline
measure: DGI (Dynamic gait index)
timeFrame: week 10
measure: DGI (Dynamic gait index)
timeFrame: week 20
measure: EmNSA
timeFrame: Baseline
measure: EmNSA
timeFrame: week 10
measure: EmNSA
timeFrame: week 20
measure: CMI (Cognitive motor interference)
timeFrame: Baseline
measure: CMI (Cognitive motor interference)
timeFrame: week 10
measure: CMI (Cognitive motor interference)
timeFrame: week 20
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Fanny Van Geel, drs.
role: STUDY_CHAIR
References:
citation: Goetschalckx M, Van Geel F, Meesen R, Triccas LT, Geraerts M, Moumdjian L, Feys P. Interlimb Coordination Performance in Seated Position in Persons With Multiple Sclerosis: Reduced Amplitude Over 6 min and Higher Coordination Variability in Persons With Walking Fatigability. Front Hum Neurosci. 2021 Oct 20;15:765254. doi: 10.3389/fnhum.2021.765254. eCollection 2021.