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| Name | Class |
|---|---|
| Revalidatie & MS Centrum Overpelt | OTHER |
| National MS Center Melsbroek | OTHER |
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The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability.
The following three research questions will be addressed:
participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| persons with Multiple Sclerosis (MS) | Active Comparator |
| |
| Healthy controls | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of walking-related fatigability | Diagnostic Test | participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability. |
| Measure | Description | Time Frame |
|---|---|---|
| Deceleration index | Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15% | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Inventory Questionnaire | Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT) | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Feys, prof. dr. | Hasselt University | Principal Investigator |
| Fanny Van Geel, drs. | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasselt University | Diepenbeek | 3590 | Belgium | |||
| National MS Center Melsbroek |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33534273 | Derived | Van Geel F, Bielen H, Theunissen K, Moumdjian L, Van Nieuwenhoven J, Van Wijmeersch B, Meesen R, Ramari C, Feys P. Clinical manifestation and perceived symptoms of walking-related performance fatigability in persons with multiple sclerosis. Int J Rehabil Res. 2021 Jun 1;44(2):118-125. doi: 10.1097/MRR.0000000000000457. | |
| 31496362 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| Symptom Inventory Questionnaire |
Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT) |
| day 4 |
| spasticity | Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT) | day 1 |
| spasticity | Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT) | day 4 |
| Strength | Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT) | day 1 |
| Strength | Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT) | day 4 |
| Balance | Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT) | day 1 |
| Balance | Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT) | day 4 |
| VAS fatigue | Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10) | day 1 |
| VAS fatigue | Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10) | day 4 |
| heart rate | Heart rate pre 6MWT and after each minute of 6MWT | day 1 |
| heart rate | Heart rate pre 6MWT and after each minute of 6MWT | day 4 |
| gait parameter | APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes. | day 1 |
| gait parameter | APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes. | day 4 |
| Cognitive fatigability | deceleration of reaction time of answers of the Alphabeth vigilance test six minutes while walking and the Alphabeth vigilance test six minutes in rest. | between week 1 and week 2 (no specific day: at the day the patients request) |
| Melsbroek |
| 1820 |
| Belgium |
| Revalidatie & MS Centrum Overpelt | Overpelt | 3900 | Belgium |
| Van Geel F, Veldkamp R, Severijns D, Dalgas U, Feys P. Day-to-day reliability, agreement and discriminative validity of measuring walking-related performance fatigability in persons with multiple sclerosis. Mult Scler. 2020 Nov;26(13):1785-1789. doi: 10.1177/1352458519872465. Epub 2019 Sep 9. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |