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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412043
• Other study ID #: Fatigability-MS-001
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2022
• Source: Hasselt University
• Contact: Peter Feys, prof. dr.
• Phone: +32 11 26 21 23
• Email: peter.feys[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Dance therapy
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.

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

Locations

Country	Name	City	State
Belgium	National MS Center Melsbroek	Overpelt
Belgium	Noorderhart Revalidatie & MS centrum	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	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	the paced auditory serial addition test (PASAT)	the paced auditory serial addition test (PASAT) to measure the cognitive fatigability	Baseline
Primary	the paced auditory serial addition test (PASAT)	the paced auditory serial addition test (PASAT) to measure the cognitive fatigability	Day 7
Primary	the paced auditory serial addition test (PASAT)	the paced auditory serial addition test (PASAT) to measure the cognitive fatigability	week 8
Primary	the symbol digit modality test (SDMT)	The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.	Baseline
Primary	the symbol digit modality test (SDMT)	The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.	Day 7
Primary	the symbol digit modality test (SDMT)	The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.	week 8
Primary	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
Primary	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
Primary	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	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.	Baseline
Secondary	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.	day 7
Secondary	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.	week 8
Secondary	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.	Baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	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.	Baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	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.	Baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	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.	Baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	Physical activity by means of step count	the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.	Baseline
Secondary	Physical activity by means of step count	the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.	day 7
Secondary	Physical activity by means of step count	the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.	week 8
Secondary	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.	Baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	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.	baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	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.	baseline
Secondary	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.	Day 7
Secondary	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.	week 8
Secondary	25-foot walk test (T25FW)	Walk as fast as possible in 7.62 meters corridor	Baseline
Secondary	25-foot walk test (T25FW)	Walk as fast as possible in 7.62 meters corridor	Day 7
Secondary	25-foot walk test (T25FW)	Walk as fast as possible in 7.62 meters corridor	week 8
Secondary	the nine-hole peg test (NHPT)	Measure of manual dexterity for both hands	Baseline
Secondary	the nine-hole peg test (NHPT)	Measure of manual dexterity for both hands	Day 7
Secondary	the nine-hole peg test (NHPT)	Measure of manual dexterity for both hands	week 8
Secondary	the 6-minute walking test	Distance travelled in every minute and total distance travelled during 6 minute walking	Baseline
Secondary	the 6-minute walking test	Distance travelled in every minute and total distance travelled during 6 minute walking	Day 7
Secondary	the 6-minute walking test	Distance travelled in every minute and total distance travelled during 6 minute walking	week 8
Secondary	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).	Baseline
Secondary	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).	Day 7
Secondary	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).	week 8