Multiple SclerosisNCT05412043
Fatigability in Persons With Multiple Sclerosis: Inputs From Cognition, Walking and Coordination
A study testing Dance therapy and Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dance therapy and Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment hindering understanding of study instructions,
- pregnancy
- musculoskeletal disorders in the lower limbs not related to MS.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Noorderhart Revalidatie & MS centrum
Overpelt, 3900
National MS Center Melsbroek
Overpelt
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Dance therapy, Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability
- Keywords
- Multiple sclerosis, Walking-fatigability, cognitive-fatigability, coordination-fatigability, Psychometric properties
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance therapyBehavioural
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-fatigabilityOther
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
| Study group | Role | What they receive |
|---|---|---|
| Persons with MS - Dance group | Experimental | 12 pwMS in the Dance Therapy intervention Receives: 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 Receives: Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability |
| Healthy controls | Placebo comparator | Not described Receives: Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 8
the paced auditory serial addition test (PASAT)
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
Measured: Baseline
the paced auditory serial addition test (PASAT)
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
Measured: Day 7
the paced auditory serial addition test (PASAT)
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
Measured: week 8
the symbol digit modality test (SDMT)
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
Measured: Baseline
the symbol digit modality test (SDMT)
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
Measured: Day 7
the symbol digit modality test (SDMT)
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 8
Secondary outcomes (39)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Physical activity by means of step count
the participants will be asked to use the accelerometer (Actigraph) during 5 days in a roll.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 8
25-foot walk test (T25FW)
Walk as fast as possible in 7.62 meters corridor
Measured: Baseline
25-foot walk test (T25FW)
Walk as fast as possible in 7.62 meters corridor
Measured: Day 7
25-foot walk test (T25FW)
Walk as fast as possible in 7.62 meters corridor
Measured: week 8
the nine-hole peg test (NHPT)
Measure of manual dexterity for both hands
Measured: Baseline
the nine-hole peg test (NHPT)
Measure of manual dexterity for both hands
Measured: Day 7
the nine-hole peg test (NHPT)
Measure of manual dexterity for both hands
Measured: week 8
the 6-minute walking test
Distance travelled in every minute and total distance travelled during 6 minute walking
Measured: Baseline
the 6-minute walking test
Distance travelled in every minute and total distance travelled during 6 minute walking
Measured: Day 7
the 6-minute walking test
Distance travelled in every minute and total distance travelled during 6 minute walking
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Sep 2021
- Primary completion30 Mar 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt UniversityCintia Ramari Ferreira, dr., Study director, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412043
- Sponsor's protocol ID
- Fatigability-MS-001
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2021
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38229519
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05412043
- Acronym / sponsor ID
- Fatigability-MS-001
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Walking-fatigability, cognitive-fatigability, coordination-fatigability, Psychometric properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Persons with MS - Dance group | Experimental | Behavioral: Dance therapy, Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability12 pwMS in the Dance Therapy intervention |
| persons with MS - excercise group | Active comparator | Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability12 pwMS in the exercise (placebo) group |
| Healthy controls | Placebo comparator | Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Cognitive impairment hindering understanding of study instructions,
- pregnancy
- musculoskeletal disorders in the lower limbs not related to MS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance therapyThe 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. | Behavioural | Persons with MS - Dance group |
| Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigabilityThe 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 | Other | Healthy controls, Persons with MS - Dance group, persons with MS - excercise group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
the paced auditory serial addition test (PASAT)
Time frame: Baseline
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
the paced auditory serial addition test (PASAT)
Time frame: Day 7
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
the paced auditory serial addition test (PASAT)
Time frame: week 8
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
the symbol digit modality test (SDMT)
Time frame: Baseline
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
the symbol digit modality test (SDMT)
Time frame: Day 7
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
the symbol digit modality test (SDMT)
Time frame: week 8
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
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.
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.
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.
39 secondary outcomes
Spatiotemporal gait parameter- Cadence
Time frame: Baseline
Spatiotemporal gait parameter- Cadence
Time frame: day 7
Spatiotemporal gait parameter- Cadence
Time frame: week 8
Spatiotemporal gait parameter- Stride length
Time frame: Baseline
Spatiotemporal gait parameter- Stride length
Time frame: Day 7
Spatiotemporal gait parameter- Stride length
Time frame: week 8
Spatiotemporal gait parameter- Gait speed
Time frame: Baseline
Spatiotemporal gait parameter- Gait speed
Time frame: Day 7
Spatiotemporal gait parameter- Gait speed
Time frame: week 8
Spatiotemporal gait parameter- Double support
Time frame: Baseline
Spatiotemporal gait parameter- Double support
Time frame: Day 7
Spatiotemporal gait parameter- Double support
Time frame: week 8
Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Baseline
Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Day 7
Short Form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: week 8
Physical activity by means of step count
Time frame: Baseline
Physical activity by means of step count
Time frame: day 7
Physical activity by means of step count
Time frame: week 8
the MFIS (modified fatigue impact scale)
Time frame: Baseline
the MFIS (modified fatigue impact scale)
Time frame: Day 7
the MFIS (modified fatigue impact scale)
Time frame: week 8
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 7
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 8
Multiple Sclerosis Walking Scale-12 item (MSWS-12)
Time frame: baseline
Multiple Sclerosis Walking Scale-12 item (MSWS-12)
Time frame: Day 7
Multiple Sclerosis Walking Scale-12 item (MSWS-12)
Time frame: week 8
25-foot walk test (T25FW)
Time frame: Baseline
25-foot walk test (T25FW)
Time frame: Day 7
25-foot walk test (T25FW)
Time frame: week 8
the nine-hole peg test (NHPT)
Time frame: Baseline
the nine-hole peg test (NHPT)
Time frame: Day 7
the nine-hole peg test (NHPT)
Time frame: week 8
the 6-minute walking test
Time frame: Baseline
the 6-minute walking test
Time frame: Day 7
the 6-minute walking test
Time frame: week 8
VAS (visual analogue scale)
Time frame: Baseline
VAS (visual analogue scale)
Time frame: Day 7
VAS (visual analogue scale)
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 38229519Santinelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, prof. dr. principal investigator
Hasselt University
Cintia Ramari Ferreira, dr. study director
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance therapy and Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The phase coordination index (PCI) (time frame: baselline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05412043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.