Clinical trial NCT05412043: Fatigability in Persons With Multiple Sclerosis: Inputs From Cognition, Walking and Coordination
Official title: Walking-related Fatigability in Persons With Multiple Sclerosis: Psychometric Properties of Cognitive and Coordination Fatigability Assessment & Proof-of-concept of a Rehabilitation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Walking-fatigability
cognitive-fatigability
coordination-fatigability
Psychometric properties
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: National MS Center Melsbroek
First posted: 2022-06-09
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Walking impairments occur in 93% of persons with MS (pwMS) within 10 years of diagnosis. Besides the impact of muscle weakness or hypertonia, one is increasingly aware about the symptom of fatigability. Motor and cognitive fatigability is a change in performance over time depending on the tasks and circumstances. It was shown that up to half of disabled pwMS slow down during walking, impacting on real life mobility. Walking function is related to functional muscle strength, balance and centrally mediated coordination deficits but also cognitive function. Preliminary data conducted by our research group has shown that people with MS with walking fatigability had a significant decrease in movement amplitude during a bipedal coordination task in sitting position. However, the psychometric properties such as within-session and test-retest reliability of bipedal function has not yet been determined. In addition, so far, no interventional research has included exclusively people with MS with walking-related fatigability. It is unknown if the downward curve in walking speed and coordination can be reversed by multi-model interventions.

The study will have two parts (A and B). Part A investigates psychometric properties of outcome measures related to fatigability in healthy controls, persons with MS with and without fatigability during walking. Part B is an intervention study in persons with MS and fatigability, comparing dance with a sham intervention, and its effects primarily on fatigability outcomes.

Detailed description: The study will have two parts (A and B). Part A includes 60 persons with Multiple Sclerosis (pwMS) and 30 healthy controls. The study consists of 2 test sessions, separated by 5-7 days of interval. The sessions 1 and 2 will be composed of cognitive test battery, questionnaires to be filled, information about the use of actigraph, clinical outcomes and interlimb coordination tests.

In the Part B the investigators propose a pilot randomized controlled trial with dance therapy to improve fatigability in pwMS. The study includes 24 pwMS presenting walking fatigability. The participants will be randomly allocated by group (n=3-4), by a person independent from the research, into the intervention group (Dance Therapy) or the active control group (control exercise). Interventions take place in groups of 3 or 4 people with MS, twice a week for eight weeks, complementary to their usual care or conventional physiotherapy.

Eligibility criteria: Inclusion Criteria:

* Persons with MS presenting walking-related fatigability (Distance walk index ≤-10);
* age between 30 and 70 years old;
* a diagnosis of MS (2017 revisions of the McDonalds criteria) with Expanded Disability Status Scale (EDSS) 4 up to 6.5.
* no relapses \>1 month preceding the start of the study
* ability to walk for 6 minutes without rest.

Exclusion Criteria:

* Cognitive impairment hindering understanding of study instructions,
* pregnancy
* musculoskeletal disorders in the lower limbs not related to MS.

Primary outcomes:
measure: The phase coordination index (PCI)
timeFrame: baselline
measure: The phase coordination index (PCI)
timeFrame: Day 7
measure: The phase coordination index (PCI)
timeFrame: week 8
measure: Movement Amplitude- Chair Coordination test
timeFrame: Baseline
measure: Movement Amplitude- Chair Coordination test
timeFrame: Day 7
measure: Movement Amplitude- Chair Coordination test
timeFrame: Week 8
measure: Movement Frequency- Chair Coordination test
timeFrame: Baseline
measure: Movement Frequency- Chair Coordination test
timeFrame: Day 7
measure: Movement Frequency- Chair Coordination test
timeFrame: week 8
measure: Workload- Chair Coordination test
timeFrame: Baseline
measure: Workload- Chair Coordination test
timeFrame: Day 7
measure: Workload- Chair Coordination test
timeFrame: week 8
measure: Motor fatigability during the 6 minutes condition
timeFrame: Baseline
measure: Motor fatigability during the 6 minutes condition
timeFrame: Day 7
measure: Motor fatigability during the 6 minutes condition
timeFrame: week 8
measure: the paced auditory serial addition test (PASAT)
timeFrame: Baseline
measure: the paced auditory serial addition test (PASAT)
timeFrame: Day 7
measure: the paced auditory serial addition test (PASAT)
timeFrame: week 8
measure: the symbol digit modality test (SDMT)
timeFrame: Baseline
measure: the symbol digit modality test (SDMT)
timeFrame: Day 7
measure: the symbol digit modality test (SDMT)
timeFrame: week 8
measure: The 6 minute walking test
timeFrame: baseline
measure: The 6 minute walking test
timeFrame: Day 7
measure: The 6 minute walking test
timeFrame: week 8
Secondary outcomes:
measure: Spatiotemporal gait parameter- Cadence
timeFrame: Baseline
measure: Spatiotemporal gait parameter- Cadence
timeFrame: day 7
measure: Spatiotemporal gait parameter- Cadence
timeFrame: week 8
measure: Spatiotemporal gait parameter- Stride length
timeFrame: Baseline
measure: Spatiotemporal gait parameter- Stride length
timeFrame: Day 7
measure: Spatiotemporal gait parameter- Stride length
timeFrame: week 8
measure: Spatiotemporal gait parameter- Gait speed
timeFrame: Baseline
measure: Spatiotemporal gait parameter- Gait speed
timeFrame: Day 7
measure: Spatiotemporal gait parameter- Gait speed
timeFrame: week 8
measure: Spatiotemporal gait parameter- Double support
timeFrame: Baseline
measure: Spatiotemporal gait parameter- Double support
timeFrame: Day 7
measure: Spatiotemporal gait parameter- Double support
timeFrame: week 8
measure: Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: Baseline
measure: Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: Day 7
measure: Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: week 8
measure: Physical activity by means of step count
timeFrame: Baseline
measure: Physical activity by means of step count
timeFrame: day 7
measure: Physical activity by means of step count
timeFrame: week 8
measure: the MFIS (modified fatigue impact scale)
timeFrame: Baseline
measure: the MFIS (modified fatigue impact scale)
timeFrame: Day 7
measure: the MFIS (modified fatigue impact scale)
timeFrame: week 8
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 7
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: week 8
measure: Multiple Sclerosis Walking Scale-12 item (MSWS-12)
timeFrame: baseline
measure: Multiple Sclerosis Walking Scale-12 item (MSWS-12)
timeFrame: Day 7
measure: Multiple Sclerosis Walking Scale-12 item (MSWS-12)
timeFrame: week 8
measure: 25-foot walk test (T25FW)
timeFrame: Baseline
measure: 25-foot walk test (T25FW)
timeFrame: Day 7
measure: 25-foot walk test (T25FW)
timeFrame: week 8
measure: the nine-hole peg test (NHPT)
timeFrame: Baseline
measure: the nine-hole peg test (NHPT)
timeFrame: Day 7
measure: the nine-hole peg test (NHPT)
timeFrame: week 8
measure: the 6-minute walking test
timeFrame: Baseline
measure: the 6-minute walking test
timeFrame: Day 7
measure: the 6-minute walking test
timeFrame: week 8
measure: VAS (visual analogue scale)
timeFrame: Baseline
measure: VAS (visual analogue scale)
timeFrame: Day 7
measure: VAS (visual analogue scale)
timeFrame: week 8
Other outcomes:
Locations:
city: Overpelt
country: Belgium
facility: Noorderhart Revalidatie & MS centrum
city: Overpelt
country: Belgium
facility: National MS Center Melsbroek
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Cintia Ramari Ferreira, dr.
role: STUDY_DIRECTOR
References: