Art for MS - Controlled Trial

Multiple Sclerosis Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938558
• Other study ID #: B9115201836892
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: April 19, 2019

Study information

• Verified date: May 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MS-Dance
The experimental group will perform 10 weeks of dance training
• MS-Art
The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Trait motor fatigue	Modified Fatigue Impact Scale (MFIS)	baseline
Primary	Trait motor fatigue	Modified Fatigue Impact Scale (MFIS)	week 10
Primary	Trait motor fatigue	Modified Fatigue Impact Scale (MFIS)	week 20
Secondary	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
Secondary	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
Secondary	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
Secondary	Perceived motor fatigability	VAS increase minute per minute during 6MWT (range 0-10)	Baseline
Secondary	Perceived motor fatigability	VAS increase minute per minute during 6MWT (range 0-10)	week 10
Secondary	Perceived motor fatigability	VAS increase minute per minute during 6MWT (range 0-10)	week 20
Secondary	Performance cognitive fatigability and cognitive capacity	PASAT and SDMT total score and correct answers last ? vs first ?	Baseline
Secondary	Performance cognitive fatigability and cognitive capacity	PASAT and SDMT total score and correct answers last ? vs first ?	week 10
Secondary	Performance cognitive fatigability and cognitive capacity	PASAT and SDMT total score and correct answers last ? vs first ?	week 20
Secondary	Trait fatigue	Fatigue Severity Scale (FSS) : range 1-7	Baseline
Secondary	Trait fatigue	Fatigue Severity Scale (FSS) : range 1-7	week 10
Secondary	Trait fatigue	Fatigue Severity Scale (FSS) : range 1-7	week 20
Secondary	MSIS-29 Questionnaire	Impact of MS via a questionnaire. 29 items, total score on 145.	Baseline
Secondary	MSIS-29 Questionnaire	Impact of MS via a questionnaire. 29 items, total score on 145.	week 10
Secondary	MSIS-29 Questionnaire	Impact of MS via a questionnaire. 29 items, total score on 145.	week 20
Secondary	SF-36 Questionnaire	Quality of Life health related questionnaire. Scale 0-100	Baseline
Secondary	SF-36 Questionnaire	Quality of Life health related questionnaire. Scale 0-100	week 10
Secondary	SF-36 Questionnaire	Quality of Life health related questionnaire. Scale 0-100	week 20
Secondary	ABC scale	Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.	Baseline
Secondary	ABC scale	Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.	week 10
Secondary	ABC scale	Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.	week 20
Secondary	MSWS-12 Questionnaire	Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.	Baseline
Secondary	MSWS-12 Questionnaire	Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.	week 10
Secondary	MSWS-12 Questionnaire	Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.	week 20
Secondary	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
Secondary	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
Secondary	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
Secondary	T25FW test	patients have to walk 25 feet as fast as possible. Determined in seconds	Baseline
Secondary	T25FW test	patients have to walk 25 feet as fast as possible. Determined in seconds	week 10
Secondary	T25FW test	patients have to walk 25 feet as fast as possible. Determined in seconds	week 20
Secondary	NHPT (Nine hole peck test)	Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.	Baseline
Secondary	NHPT (Nine hole peck test)	Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.	week 10
Secondary	NHPT (Nine hole peck test)	Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.	week 20
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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