Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.

Multiple Sclerosis Clinical Trial

Official title:

Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860675
• Other study ID #: FaVG-001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: February 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability.

The following three research questions will be addressed:

1. How prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure?

2. What are associated symptoms of walking-related motor fatigability and how long does this manifest?

3. What is the relationship between cognitive fatigability and walking-related performance fatigability?

participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18 - 70 years

• Confirmed diagnosis according to the McDonald criteria

• Performed a 6MWT before, to ensure familiarization

• Able to walk independently or with unilateral support for 6 minutes without rest

• Signed the informed consent

Exclusion Criteria:

• Exacerbation or relapse within last 3 months before study

• Other neurological diagnosis, such as stroke and Parkinson

• MS-like syndromes, such as neuromyelitis optica

• Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Assessment of walking-related fatigability
participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek
Belgium	National MS Center Melsbroek	Melsbroek
Belgium	Revalidatie & MS Centrum Overpelt	Overpelt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deceleration index	Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%	day 1
Secondary	Symptom Inventory Questionnaire	Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT)	day 1
Secondary	Symptom Inventory Questionnaire	Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT)	day 4
Secondary	spasticity	Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)	day 1
Secondary	spasticity	Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)	day 4
Secondary	Strength	Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)	day 1
Secondary	Strength	Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)	day 4
Secondary	Balance	Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)	day 1
Secondary	Balance	Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)	day 4
Secondary	VAS fatigue	Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)	day 1
Secondary	VAS fatigue	Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)	day 4
Secondary	heart rate	Heart rate pre 6MWT and after each minute of 6MWT	day 1
Secondary	heart rate	Heart rate pre 6MWT and after each minute of 6MWT	day 4
Secondary	gait parameter	APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.	day 1
Secondary	gait parameter	APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.	day 4
Secondary	Cognitive fatigability	deceleration of reaction time of answers of the Alphabeth vigilance test six minutes while walking and the Alphabeth vigilance test six minutes in rest.	between week 1 and week 2 (no specific day: at the day the patients request)