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Art for MS - Controlled Trial

Primary Purpose

Multiple Sclerosis, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MS-Dance
MS-Art
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring multiple sclerosis, fatigue

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hasselt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dance intervention group

Art intervention group

Arm Description

Dancers at beginners level Dancers at advanced level

Paint artists Word artists Film artists Photographers

Outcomes

Primary Outcome Measures

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
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
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
Trait motor fatigue
Modified Fatigue Impact Scale (MFIS)
Trait motor fatigue
Modified Fatigue Impact Scale (MFIS)
Trait motor fatigue
Modified Fatigue Impact Scale (MFIS)

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2019
Last Updated
May 28, 2020
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT03938558
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Does a multimodal dance intervention have positive effects on walking-related fatigability? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Fatigue
Keywords
multiple sclerosis, fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance intervention group
Arm Type
Experimental
Arm Description
Dancers at beginners level Dancers at advanced level
Arm Title
Art intervention group
Arm Type
Active Comparator
Arm Description
Paint artists Word artists Film artists Photographers
Intervention Type
Other
Intervention Name(s)
MS-Dance
Intervention Description
The experimental group will perform 10 weeks of dance training
Intervention Type
Other
Intervention Name(s)
MS-Art
Intervention Description
The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)
Primary Outcome Measure Information:
Title
motor fatigability
Description
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
Time Frame
Baseline
Title
motor fatigability
Description
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
Time Frame
week 10
Title
motor fatigability
Description
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
Time Frame
week 20
Title
Trait motor fatigue
Description
Modified Fatigue Impact Scale (MFIS)
Time Frame
baseline
Title
Trait motor fatigue
Description
Modified Fatigue Impact Scale (MFIS)
Time Frame
week 10
Title
Trait motor fatigue
Description
Modified Fatigue Impact Scale (MFIS)
Time Frame
week 20
Secondary Outcome Measure Information:
Title
Coördination test with lower limbs
Description
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)
Time Frame
baseline
Title
Coördination test with lower limbs
Description
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)
Time Frame
week 10
Title
Coördination test with lower limbs
Description
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)
Time Frame
week 20
Title
Perceived motor fatigability
Description
VAS increase minute per minute during 6MWT (range 0-10)
Time Frame
Baseline
Title
Perceived motor fatigability
Description
VAS increase minute per minute during 6MWT (range 0-10)
Time Frame
week 10
Title
Perceived motor fatigability
Description
VAS increase minute per minute during 6MWT (range 0-10)
Time Frame
week 20
Title
Performance cognitive fatigability and cognitive capacity
Description
PASAT and SDMT total score and correct answers last ⅓ vs first ⅓
Time Frame
Baseline
Title
Performance cognitive fatigability and cognitive capacity
Description
PASAT and SDMT total score and correct answers last ⅓ vs first ⅓
Time Frame
week 10
Title
Performance cognitive fatigability and cognitive capacity
Description
PASAT and SDMT total score and correct answers last ⅓ vs first ⅓
Time Frame
week 20
Title
Trait fatigue
Description
Fatigue Severity Scale (FSS) : range 1-7
Time Frame
Baseline
Title
Trait fatigue
Description
Fatigue Severity Scale (FSS) : range 1-7
Time Frame
week 10
Title
Trait fatigue
Description
Fatigue Severity Scale (FSS) : range 1-7
Time Frame
week 20
Title
MSIS-29 Questionnaire
Description
Impact of MS via a questionnaire. 29 items, total score on 145.
Time Frame
Baseline
Title
MSIS-29 Questionnaire
Description
Impact of MS via a questionnaire. 29 items, total score on 145.
Time Frame
week 10
Title
MSIS-29 Questionnaire
Description
Impact of MS via a questionnaire. 29 items, total score on 145.
Time Frame
week 20
Title
SF-36 Questionnaire
Description
Quality of Life health related questionnaire. Scale 0-100
Time Frame
Baseline
Title
SF-36 Questionnaire
Description
Quality of Life health related questionnaire. Scale 0-100
Time Frame
week 10
Title
SF-36 Questionnaire
Description
Quality of Life health related questionnaire. Scale 0-100
Time Frame
week 20
Title
ABC scale
Description
Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.
Time Frame
Baseline
Title
ABC scale
Description
Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.
Time Frame
week 10
Title
ABC scale
Description
Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.
Time Frame
week 20
Title
MSWS-12 Questionnaire
Description
Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.
Time Frame
Baseline
Title
MSWS-12 Questionnaire
Description
Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.
Time Frame
week 10
Title
MSWS-12 Questionnaire
Description
Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.
Time Frame
week 20
Title
5xSTS T25FW
Description
5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds
Time Frame
Baseline
Title
5xSTS T25FW
Description
5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds
Time Frame
week 10
Title
5xSTS T25FW
Description
5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds
Time Frame
week 20
Title
T25FW test
Description
patients have to walk 25 feet as fast as possible. Determined in seconds
Time Frame
Baseline
Title
T25FW test
Description
patients have to walk 25 feet as fast as possible. Determined in seconds
Time Frame
week 10
Title
T25FW test
Description
patients have to walk 25 feet as fast as possible. Determined in seconds
Time Frame
week 20
Title
NHPT (Nine hole peck test)
Description
Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.
Time Frame
Baseline
Title
NHPT (Nine hole peck test)
Description
Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.
Time Frame
week 10
Title
NHPT (Nine hole peck test)
Description
Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.
Time Frame
week 20
Title
DGI (Dynamic gait index)
Description
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
Time Frame
Baseline
Title
DGI (Dynamic gait index)
Description
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
Time Frame
week 10
Title
DGI (Dynamic gait index)
Description
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
Time Frame
week 20
Title
EmNSA
Description
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
Time Frame
Baseline
Title
EmNSA
Description
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
Time Frame
week 10
Title
EmNSA
Description
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
Time Frame
week 20
Title
CMI (Cognitive motor interference)
Description
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.
Time Frame
Baseline
Title
CMI (Cognitive motor interference)
Description
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.
Time Frame
week 10
Title
CMI (Cognitive motor interference)
Description
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.
Time Frame
week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fanny Van Geel, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34744669
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.
Results Reference
derived

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Art for MS - Controlled Trial

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