Fatigability in Persons With Multiple Sclerosis: Inputs From Cognition, Walking and Coordination

NCT05412043 | Completed

• 1 other identifier: Fatigability-MS-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Walking-fatigability; cognitive-fatigability; coordination-fatigability; Psychometric properties

Outcome Measures

Primary Outcomes (24)

• The phase coordination index (PCI)

  The phase coordination index (PCI) will be used to analyse the consistency and accuracy in generating antiphase left-right knee movements on an instrumented chair. Participants will be instructed to perform antiphase movements of knee flexion and extension.

  baselline

• The phase coordination index (PCI)

  The phase coordination index (PCI) will be used to analyse the consistency and accuracy in generating antiphase left-right knee movements on an instrumented chair. Participants will be instructed to perform antiphase movements of knee flexion and extension.

  Day 7

• The phase coordination index (PCI)

  The phase coordination index (PCI) will be used to analyse the consistency and accuracy in generating antiphase left-right knee movements on an instrumented chair. Participants will be instructed to perform antiphase movements of knee flexion and extension.

  week 8

• Movement Amplitude- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement amplitude: peak-to-peak amplitude for each individual cycle.

  Baseline

• Movement Amplitude- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement amplitude: peak-to-peak amplitude for each individual cycle.

  Day 7

• Movement Amplitude- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement amplitude: peak-to-peak amplitude for each individual cycle.

  Week 8

• Movement Frequency- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement frequency: the number of complete movements performed during one minute.

  Baseline

• Movement Frequency- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement frequency: the number of complete movements performed during one minute.

  Day 7

• Movement Frequency- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement frequency: the number of complete movements performed during one minute.

  week 8

• Workload- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include workload (movement frequency\*movement amplitude): average amplitude multiplied by the frequency, to quantify the interaction pattern.

  Baseline

• Workload- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include workload (movement frequency\*movement amplitude): average amplitude multiplied by the frequency, to quantify the interaction pattern.

  Day 7

• Workload- Chair Coordination test

  Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include workload (movement frequency\*movement amplitude): average amplitude multiplied by the frequency, to quantify the interaction pattern.

  week 8

• Motor fatigability during the 6 minutes condition

  Motor fatigability during the 6 minutes condition (amplitude; frequency; workload): the percentage decline from the last minute (min 6) to the first minute will be calculated, based on the Distance Walking Index formula, for every coordination outcome.

  Baseline

• Motor fatigability during the 6 minutes condition

  Motor fatigability during the 6 minutes condition (amplitude; frequency; workload): the percentage decline from the last minute (min 6) to the first minute will be calculated, based on the Distance Walking Index formula, for every coordination outcome.

  Day 7

• Motor fatigability during the 6 minutes condition

  Motor fatigability during the 6 minutes condition (amplitude; frequency; workload): the percentage decline from the last minute (min 6) to the first minute will be calculated, based on the Distance Walking Index formula, for every coordination outcome.

  week 8

• the paced auditory serial addition test (PASAT)

  the paced auditory serial addition test (PASAT) to measure the cognitive fatigability

  Baseline

• the paced auditory serial addition test (PASAT)

  the paced auditory serial addition test (PASAT) to measure the cognitive fatigability

  Day 7

• the paced auditory serial addition test (PASAT)

  the paced auditory serial addition test (PASAT) to measure the cognitive fatigability

  week 8

• the symbol digit modality test (SDMT)

  The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.

  Baseline

• the symbol digit modality test (SDMT)

  The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.

  Day 7

• the symbol digit modality test (SDMT)

  The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.

  week 8

• The 6 minute walking test

  Participants will perform the 6-minute walking test. The distance walked in each minute will be collected to calculate the Distance Walked Index (DWI) as follow: DWI = (Distance covered in the last minute - distance covered in the first minute)/distance covered in the first minute\*100.

  baseline

• The 6 minute walking test

  Participants will perform the 6-minute walking test. The distance walked in each minute will be collected to calculate the Distance Walked Index (DWI) as follow: DWI = (Distance covered in the last minute - distance covered in the first minute)/distance covered in the first minute\*100.

  Day 7

• The 6 minute walking test

  Participants will perform the 6-minute walking test. The distance walked in each minute will be collected to calculate the Distance Walked Index (DWI) as follow: DWI = (Distance covered in the last minute - distance covered in the first minute)/distance covered in the first minute\*100.

  week 8

Secondary Outcomes (39)

• Spatiotemporal gait parameter- Cadence

  Baseline

• Spatiotemporal gait parameter- Cadence

  day 7

• Spatiotemporal gait parameter- Cadence

  week 8

• Spatiotemporal gait parameter- Stride length

  Baseline

• Spatiotemporal gait parameter- Stride length

  Day 7

Study Arms (3)

Persons with MS - Dance group

EXPERIMENTAL

12 pwMS in the Dance Therapy intervention

Behavioral: Dance therapy; Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability

persons with MS - excercise group

ACTIVE COMPARATOR

12 pwMS in the exercise (placebo) group

Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability

Healthy controls

PLACEBO COMPARATOR

Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability

Interventions

Dance therapy BEHAVIORAL

The dance group will attend choreo-based dance therapy which includes both cognitive training to remember the choreo's and motor training to execute them (with and without music). Each session will consist of a ten-minute warm up, dance training and a ten-minute cool down. The participants will be taught three choreographies, which will increase in difficulty level. 1) floor work on a slow rhythm with focus on proprioception, abdominal muscle strength, coordination and working memory. 2) slow paced with a group part and a canon part with focus on working memory, static and dynamic balance and strength. Furthermore, it will require dynamic balance, walking and cognition. 3) higher rhythm and will be danced with a cane which will require more speed, coordination and dual tasking.

Persons with MS - Dance group

Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability OTHER

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

Healthy controls; Persons with MS - Dance group; persons with MS - excercise group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator
• National MS Center Melsbroek: collaborator

Study Sites (2)

Noorderhart Revalidatie & MS centrum

Overpelt, 3900, Belgium

Location

National MS Center Melsbroek

Overpelt, Belgium

Location

Related Publications (1)

• Santinelli FB, Ramari C, Poncelet M, Severijns D, Kos D, Pau M, Kalron A, Meyns P, Feys P. Between-Day Reliability of the Gait Characteristics and Their Changes During the 6-Minute Walking Test in People With Multiple Sclerosis. Neurorehabil Neural Repair. 2024 Feb;38(2):75-86. doi: 10.1177/15459683231222412. Epub 2024 Jan 16.

  PMID: 38229519 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dance Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise Movement Techniques; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Cintia Ramari Ferreira, dr.

  Hasselt University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: June 9, 2022
• Study Start: September 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: May 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

BE (2)