Skip to main content
OpenTrials
Completed

NCT Number: NCT05412043

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National MS Center Melsbroek, Overpelt, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. The phase coordination index (PCI)

    Time frame: baselline

    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.

  2. The phase coordination index (PCI)

    Time frame: Day 7

    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.

  3. The phase coordination index (PCI)

    Time frame: week 8

    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.

  4. Movement Amplitude- Chair Coordination test

    Time frame: Baseline

    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.

  5. Movement Amplitude- Chair Coordination test

    Time frame: Day 7

    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.

  6. Movement Amplitude- Chair Coordination test

    Time frame: Week 8

    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.

  7. Movement Frequency- Chair Coordination test

    Time frame: Baseline

    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.

  8. Movement Frequency- Chair Coordination test

    Time frame: Day 7

    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.

  9. Movement Frequency- Chair Coordination test

    Time frame: week 8

    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.

  10. Workload- Chair Coordination test

    Time frame: Baseline

    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.

  11. Workload- Chair Coordination test

    Time frame: Day 7

    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.

  12. Workload- Chair Coordination test

    Time frame: week 8

    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.

  13. Motor fatigability during the 6 minutes condition

    Time frame: Baseline

    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.

  14. Motor fatigability during the 6 minutes condition

    Time frame: Day 7

    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.

  15. Motor fatigability during the 6 minutes condition

    Time frame: week 8

    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.

  16. the paced auditory serial addition test (PASAT)

    Time frame: Baseline

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

  17. the paced auditory serial addition test (PASAT)

    Time frame: Day 7

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

  18. the paced auditory serial addition test (PASAT)

    Time frame: week 8

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

  19. the symbol digit modality test (SDMT)

    Time frame: Baseline

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

  20. the symbol digit modality test (SDMT)

    Time frame: Day 7

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

  21. the symbol digit modality test (SDMT)

    Time frame: week 8

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

  22. The 6 minute walking test

    Time frame: baseline

    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.

  23. The 6 minute walking test

    Time frame: Day 7

    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.

  24. The 6 minute walking test

    Time frame: week 8

    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.

Secondary outcomes

  1. Spatiotemporal gait parameter- Cadence

    Time frame: Baseline

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Cadence (number of steps per minute) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  2. Spatiotemporal gait parameter- Cadence

    Time frame: day 7

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Cadence (number of steps per minute) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  3. Spatiotemporal gait parameter- Cadence

    Time frame: week 8

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Cadence (number of steps per minute) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  4. Spatiotemporal gait parameter- Stride length

    Time frame: Baseline

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Stride length (anteroposterior distance between two consecutive heel contact of the same foot, in meters) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  5. Spatiotemporal gait parameter- Stride length

    Time frame: Day 7

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Stride length (anteroposterior distance between two consecutive heel contact of the same foot, in meters) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  6. Spatiotemporal gait parameter- Stride length

    Time frame: week 8

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Stride length (anteroposterior distance between two consecutive heel contact of the same foot, in meters) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  7. Spatiotemporal gait parameter- Gait speed

    Time frame: Baseline

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Gait Speed (distance divided by time- meters per second) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  8. Spatiotemporal gait parameter- Gait speed

    Time frame: Day 7

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Gait Speed (distance divided by time- meters per second) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  9. Spatiotemporal gait parameter- Gait speed

    Time frame: week 8

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Gait Speed (distance divided by time- meters per second) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  10. Spatiotemporal gait parameter- Double support

    Time frame: Baseline

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Double Support (relative values related to the gait cycle, in percentage, that both feet are in contact with the ground) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  11. Spatiotemporal gait parameter- Double support

    Time frame: Day 7

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Double Support (relative values related to the gait cycle, in percentage, that both feet are in contact with the ground) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  12. Spatiotemporal gait parameter- Double support

    Time frame: week 8

    Participants will be equipped with five portable APDM sensors (OPAL, USA, https://www.apdm.com/wearable-sensors/) to measure spatiotemporal gait parameters. Two sensors will be strapped on their ankles, two on their wrists, and one on the sternum. Double Support (relative values related to the gait cycle, in percentage, that both feet are in contact with the ground) will be collected throughout the walking conditions (T25FW and 6MWT) and analyzed.

  13. Short Form of the International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: Baseline

    Physical activity questionnaire, the short form contains 9-items and records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.

  14. Short Form of the International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: Day 7

    Physical activity questionnaire, the short form contains 9-items and records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.

  15. Short Form of the International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: week 8

    Physical activity questionnaire, the short form contains 9-items and records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.

  16. Physical activity by means of step count

    Time frame: Baseline

    the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.

  17. Physical activity by means of step count

    Time frame: day 7

    the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.

  18. Physical activity by means of step count

    Time frame: week 8

    the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.

  19. the MFIS (modified fatigue impact scale)

    Time frame: Baseline

    The Modified fatigue impact scale is a 21-item questionnaire, questioning the impact of fatigue, and self-reported trait of fatigue, where higher values indicate more fatigue (maximum score of 84 points) and lower values (minimum score of 0) means less fatigue.

  20. the MFIS (modified fatigue impact scale)

    Time frame: Day 7

    The Modified fatigue impact scale is a 21-item questionnaire, questioning the impact of fatigue, and self-reported trait of fatigue, where higher values indicate more fatigue (maximum score of 84 points) and lower values (minimum score of 0) means less fatigue.

  21. the MFIS (modified fatigue impact scale)

    Time frame: week 8

    The Modified fatigue impact scale is a 21-item questionnaire, questioning the impact of fatigue, and self-reported trait of fatigue, where higher values indicate more fatigue (maximum score of 84 points) and lower values (minimum score of 0) means less fatigue.

  22. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. The component scores are summed to produce a global score (range from 0 to 21). Higher scores indicate worse sleep quality and lower scores better sleep quality.

  23. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Day 7

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. The component scores are summed to produce a global score (range from 0 to 21). Higher scores indicate worse sleep quality and lower scores better sleep quality.

  24. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: week 8

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. The component scores are summed to produce a global score (range from 0 to 21). Higher scores indicate worse sleep quality and lower scores better sleep quality.

  25. Multiple Sclerosis Walking Scale-12 item (MSWS-12)

    Time frame: baseline

    The Multiple Sclerosis Walking Scale-12 item (MSWS-12) is a self-reported scale with to identify how people with multiple sclerosis perceived their walking ability. The questionnaire has 12 questions, with a minimum sum of 12 points and a maximum of 60 points. After, these values are transformed into a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.

  26. Multiple Sclerosis Walking Scale-12 item (MSWS-12)

    Time frame: Day 7

    The Multiple Sclerosis Walking Scale-12 item (MSWS-12) is a self-reported scale with to identify how people with multiple sclerosis perceived their walking ability. The questionnaire has 12 questions, with a minimum sum of 12 points and a maximum of 60 points. After, these values are transformed into a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.

  27. Multiple Sclerosis Walking Scale-12 item (MSWS-12)

    Time frame: week 8

    The Multiple Sclerosis Walking Scale-12 item (MSWS-12) is a self-reported scale with to identify how people with multiple sclerosis perceived their walking ability. The questionnaire has 12 questions, with a minimum sum of 12 points and a maximum of 60 points. After, these values are transformed into a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.

  28. 25-foot walk test (T25FW)

    Time frame: Baseline

    Walk as fast as possible in 7.62 meters corridor

  29. 25-foot walk test (T25FW)

    Time frame: Day 7

    Walk as fast as possible in 7.62 meters corridor

  30. 25-foot walk test (T25FW)

    Time frame: week 8

    Walk as fast as possible in 7.62 meters corridor

  31. the nine-hole peg test (NHPT)

    Time frame: Baseline

    Measure of manual dexterity for both hands

  32. the nine-hole peg test (NHPT)

    Time frame: Day 7

    Measure of manual dexterity for both hands

  33. the nine-hole peg test (NHPT)

    Time frame: week 8

    Measure of manual dexterity for both hands

  34. the 6-minute walking test

    Time frame: Baseline

    Distance travelled in every minute and total distance travelled during 6 minute walking

  35. the 6-minute walking test

    Time frame: Day 7

    Distance travelled in every minute and total distance travelled during 6 minute walking

  36. the 6-minute walking test

    Time frame: week 8

    Distance travelled in every minute and total distance travelled during 6 minute walking

  37. VAS (visual analogue scale)

    Time frame: Baseline

    The Visual Analogue Scale (VAS), will access the perceived fatigue during the 6-minute walking test, and the seated interlimb coordination test. The VAS will be asked every minute. The VAS range from 0 (no fatigue) to 10 (extremely fatigued).

  38. VAS (visual analogue scale)

    Time frame: Day 7

    The Visual Analogue Scale (VAS), will access the perceived fatigue during the 6-minute walking test, and the seated interlimb coordination test. The VAS will be asked every minute. The VAS range from 0 (no fatigue) to 10 (extremely fatigued).

  39. VAS (visual analogue scale)

    Time frame: week 8

    The Visual Analogue Scale (VAS), will access the perceived fatigue during the 6-minute walking test, and the seated interlimb coordination test. The VAS will be asked every minute. The VAS range from 0 (no fatigue) to 10 (extremely fatigued).

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Registry information

Official study title

Walking-related Fatigability in Persons With Multiple Sclerosis: Psychometric Properties of Cognitive and Coordination Fatigability Assessment & Proof-of-concept of a Rehabilitation Intervention

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.