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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
16
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.
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
Noorderhart Revalidatie & MS centrum
Overpelt, Belgium
National MS Center Melsbroek
Overpelt, Belgium
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 8
the paced auditory serial addition test (PASAT)
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
Time frame: Baseline
the paced auditory serial addition test (PASAT)
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
Time frame: Day 7
the paced auditory serial addition test (PASAT)
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
Time frame: week 8
the symbol digit modality test (SDMT)
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
Time frame: Baseline
the symbol digit modality test (SDMT)
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
Time frame: Day 7
the symbol digit modality test (SDMT)
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 8
Spatiotemporal gait parameter- Cadence
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.
Time frame: Baseline
Spatiotemporal gait parameter- Cadence
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.
Time frame: day 7
Spatiotemporal gait parameter- Cadence
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.
Time frame: week 8
Spatiotemporal gait parameter- Stride length
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.
Time frame: Baseline
Spatiotemporal gait parameter- Stride length
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.
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Time frame: Day 7
Spatiotemporal gait parameter- Stride length
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.
Time frame: week 8
Spatiotemporal gait parameter- Gait speed
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.
Time frame: Baseline
Spatiotemporal gait parameter- Gait speed
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.
Time frame: Day 7
Spatiotemporal gait parameter- Gait speed
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.
Time frame: week 8
Spatiotemporal gait parameter- Double support
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.
Time frame: Baseline
Spatiotemporal gait parameter- Double support
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.
Time frame: Day 7
Spatiotemporal gait parameter- Double support
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.
Time frame: week 8
Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
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.
Time frame: Baseline
Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
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.
Time frame: Day 7
Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
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.
Time frame: week 8
Physical activity by means of step count
the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.
Time frame: Baseline
Physical activity by means of step count
the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.
Time frame: day 7
Physical activity by means of step count
the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.
Time frame: week 8
the MFIS (modified fatigue impact scale)
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.
Time frame: Baseline
the MFIS (modified fatigue impact scale)
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.
Time frame: Day 7
the MFIS (modified fatigue impact scale)
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.
Time frame: week 8
The Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: baseline
The Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Day 7
The Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: week 8
Multiple Sclerosis Walking Scale-12 item (MSWS-12)
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.
Time frame: baseline
Multiple Sclerosis Walking Scale-12 item (MSWS-12)
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.
Time frame: Day 7
Multiple Sclerosis Walking Scale-12 item (MSWS-12)
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.
Time frame: week 8
25-foot walk test (T25FW)
Walk as fast as possible in 7.62 meters corridor
Time frame: Baseline
25-foot walk test (T25FW)
Walk as fast as possible in 7.62 meters corridor
Time frame: Day 7
25-foot walk test (T25FW)
Walk as fast as possible in 7.62 meters corridor
Time frame: week 8
the nine-hole peg test (NHPT)
Measure of manual dexterity for both hands
Time frame: Baseline
the nine-hole peg test (NHPT)
Measure of manual dexterity for both hands
Time frame: Day 7
the nine-hole peg test (NHPT)
Measure of manual dexterity for both hands
Time frame: week 8
the 6-minute walking test
Distance travelled in every minute and total distance travelled during 6 minute walking
Time frame: Baseline
the 6-minute walking test
Distance travelled in every minute and total distance travelled during 6 minute walking
Time frame: Day 7
the 6-minute walking test
Distance travelled in every minute and total distance travelled during 6 minute walking
Time frame: week 8
VAS (visual analogue scale)
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).
Time frame: Baseline
VAS (visual analogue scale)
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).
Time frame: Day 7
VAS (visual analogue scale)
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).
Time frame: week 8