Art for MS - Controlled Trial

Not Applicable

Completed

• Conditions: Fatigue; Multiple Sclerosis
• Interventions: Other: MS-Dance; Other: MS-Art

• Registration Number: NCT03938558
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study Start: 2018-08-28
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dance intervention group	MS-Dance	* Dancers at beginners level * Dancers at advanced level
Art intervention group	MS-Art	* Paint artists * Word artists * Film artists * Photographers

Primary Outcome Measures

Name	Time	Method
motor fatigability	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
Trait motor fatigue	week 20	Modified Fatigue Impact Scale (MFIS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Belgium