Art for MS - Controlled Trial

NCT03938558 | Completed

• 1 other identifier: B9115201836892
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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. 1.Does a multimodal dance intervention have positive effects on walking-related fatigability?
2. 2.Does a multimodal dance intervention have positive effects on other MS symptoms related to fatigue and fatigability?

Conditions

Multiple Sclerosis; Fatigue

Keywords

multiple sclerosis; fatigue

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (42)

• Coördination test with lower limbs

  baseline

• Coördination test with lower limbs

  week 10

• Coördination test with lower limbs

  week 20

• Perceived motor fatigability

  Baseline

• Perceived motor fatigability

  week 10

Study Arms (2)

Dance intervention group

EXPERIMENTAL

* Dancers at beginners level * Dancers at advanced level

Other: MS-Dance

Art intervention group

ACTIVE COMPARATOR

* Paint artists * Word artists * Film artists * Photographers

Other: MS-Art

Interventions

MS-Dance OTHER

The experimental group will perform 10 weeks of dance training

Dance intervention group

MS-Art OTHER

The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)

Art intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34744669 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Fanny Van Geel, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: August 28, 2018
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

BE (1)