Art for MS - Controlled Trial

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

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?

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Fatigue
• Intervention / Treatment: Other: MS-Dance; Other: MS-Art

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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, …)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Study Chair: Fanny Van Geel, drs., Hasselt University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): April 19, 2019
• Study Completion (Actual): April 19, 2019

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; multiple sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: B9115201836892

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No