Multiple Sclerosis Clinical Trial
— FAMPISEPOfficial title:
Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances
Verified date | January 2021 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective monocentric open label trial was realized in the Laboratory of Clinical Functional Exploration of Movement at the University Hospital of Besancon. Cognitive evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation, respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1. Fampridine was prescribed according to guidelines issued by the French Health Products Safety Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were classified into 2 groups: responders whose clinical status was improved and non-responders whose clinical status was not improved.
Status | Completed |
Enrollment | 89 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - MS diagnostic regarding the modified McDonald criteria - EDSS status between 4.0 and 6.5 - patients able to walk during 6 minutes Exclusion Criteria: - increasing MS symptoms during the previous 60 days - history of epilepsy or epileptic seizure - immunotherapy change in the previous 60 days - beginning anti-spastic treatment in the previous 30 days - beginning treatment that is able to decrease fatigue symptoms in the previous 30 days - modification of the rehabilitation program during the study - renal insufficiency (creatinine clearance <80ml.min-1 given by the Cockroft-Gault formula) - concomitant treatment by organic cation transporter 2 inhibitor - hypersensitivity to fampridine |
Country | Name | City | State |
---|---|---|---|
France | CHU Jean Minjoz | Besancon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Allart E, Benoit A, Blanchard-Dauphin A, Tiffreau V, Thevenon A, Zephir H, Outteryck O, Lacour A, Vermersch P. Sustained-released fampridine in multiple sclerosis: effects on gait parameters, arm function, fatigue, and quality of life. J Neurol. 2015 Aug; — View Citation
Almarwani M, Perera S, VanSwearingen JM, Sparto PJ, Brach JS. The test-retest reliability and minimal detectable change of spatial and temporal gait variability during usual over-ground walking for younger and older adults. Gait Posture. 2016 Feb;44:94-9. — View Citation
Baert I, Freeman J, Smedal T, Dalgas U, Romberg A, Kalron A, Conyers H, Elorriaga I, Gebara B, Gumse J, Heric A, Jensen E, Jones K, Knuts K, Maertens de Noordhout B, Martic A, Normann B, Eijnde BO, Rasova K, Santoyo Medina C, Truyens V, Wens I, Feys P. Re — View Citation
Baroin A, Chopard G, Siliman G, Michoudet C, Vivot A, Vidal C, Mokadym H, Lavier A, Berger E, Rumbach L, Rude N. Validation of a new quality of life scale related to multiple sclerosis and relapses. Qual Life Res. 2013 Oct;22(8):1943-54. doi: 10.1007/s111 — View Citation
Bland JM, Altman DG. Measurement error. BMJ. 1996 Jun 29;312(7047):1654. Corrected and republished in: BMJ. 1996 Sep 21;313(7059):744. — View Citation
Brochet B, Deloire MS, Bonnet M, Salort-Campana E, Ouallet JC, Petry KG, Dousset V. Should SDMT substitute for PASAT in MSFC? A 5-year longitudinal study. Mult Scler. 2008 Nov;14(9):1242-9. doi: 10.1177/1352458508094398. Epub 2008 Jul 24. — View Citation
Confavreux C, Vukusic S. The clinical epidemiology of multiple sclerosis. Neuroimaging Clin N Am. 2008 Nov;18(4):589-622, ix-x. doi: 10.1016/j.nic.2008.09.002. Review. — View Citation
de Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006 Oct;59(10):1033-9. Epub 2006 Aug 10. — View Citation
Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32. — View Citation
Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. — View Citation
Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31. — View Citation
Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. Epub 2007 Oct 17. — View Citation
Goodkin DE. EDSS reliability. Neurology. 1991 Feb;41(2 ( Pt 1)):332. — View Citation
Goodman AD, Bethoux F, Brown TR, Schapiro RT, Cohen R, Marinucci LN, Henney HR 3rd, Blight AR; MS-F203, MS-F204, and Extension Study Investigators. Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: — View Citation
Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240. — View Citation
Hobart J, Blight AR, Goodman A, Lynn F, Putzki N. Timed 25-foot walk: direct evidence that improving 20% or greater is clinically meaningful in MS. Neurology. 2013 Apr 16;80(16):1509-17. doi: 10.1212/WNL.0b013e31828cf7f3. Epub 2013 Mar 27. Review. — View Citation
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. — View Citation
Kalron A, Dvir Z, Achiron A. Walking while talking--difficulties incurred during the initial stages of multiple sclerosis disease process. Gait Posture. 2010 Jul;32(3):332-5. doi: 10.1016/j.gaitpost.2010.06.002. Epub 2010 Jul 1. — View Citation
Kalron A. Gait variability across the disability spectrum in people with multiple sclerosis. J Neurol Sci. 2016 Feb 15;361:1-6. doi: 10.1016/j.jns.2015.12.012. Epub 2015 Dec 10. — View Citation
Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20. — View Citation
Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f. — View Citation
Moon Y, Wajda DA, Motl RW, Sosnoff JJ. Stride-Time Variability and Fall Risk in Persons with Multiple Sclerosis. Mult Scler Int. 2015;2015:964790. doi: 10.1155/2015/964790. Epub 2015 Dec 30. — View Citation
Motl RW, Dlugonski D, Suh Y, Weikert M, Fernhall B, Goldman M. Accelerometry and its association with objective markers of walking limitations in ambulatory adults with multiple sclerosis. Arch Phys Med Rehabil. 2010 Dec;91(12):1942-7. doi: 10.1016/j.apmr — View Citation
Motl RW, Sosnoff JJ, Dlugonski D, Pilutti LA, Klaren R, Sandroff BM. Walking and cognition, but not symptoms, correlate with dual task cost of walking in multiple sclerosis. Gait Posture. 2014 Mar;39(3):870-4. doi: 10.1016/j.gaitpost.2013.11.023. Epub 201 — View Citation
Pilutti LA, Dlugonski D, Sandroff BM, Suh Y, Pula JH, Sosnoff JJ, Motl RW. Gait and six-minute walk performance in persons with multiple sclerosis. J Neurol Sci. 2013 Nov 15;334(1-2):72-6. doi: 10.1016/j.jns.2013.07.2511. Epub 2013 Jul 30. — View Citation
Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Crit — View Citation
Sandroff BM, Pilutti LA, Motl RW. Does the six-minute walk test measure walking performance or physical fitness in persons with multiple sclerosis? NeuroRehabilitation. 2015;37(1):149-55. doi: 10.3233/NRE-151247. — View Citation
van Uden CJ, Besser MP. Test-retest reliability of temporal and spatial gait characteristics measured with an instrumented walkway system (GAITRite). BMC Musculoskelet Disord. 2004 May 17;5:13. — View Citation
Vlaar AM, Wade DT. Verbal fluency assessment of patients with multiple sclerosis: test-retest and inter-observer reliability. Clin Rehabil. 2003 Nov;17(7):756-64. — View Citation
Wajda DA, Motl RW, Sosnoff JJ. Dual task cost of walking is related to fall risk in persons with multiple sclerosis. J Neurol Sci. 2013 Dec 15;335(1-2):160-3. doi: 10.1016/j.jns.2013.09.021. Epub 2013 Sep 20. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 Minute Walk Test (6MWT) | The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds. | Timed 21 days | |
Secondary | Verbal fluencies | Both semantic and phonological verbal fluencies were assessed in a quiet room. Semantic fluency was measured by asking patients to provide as many animal names as possible in 120 s. Different kinds of one sort of animal were accepted (e.g. kinds of birds or fish). Phonological fluency was measured by asking patients to provide as many words as possible beginning with the letter 'P' in 120 s. They were informed that proper nouns and words with the same stem would not be counted (e.g. pen, pencil). Patients were instructed to avoid repetitions. | Day 1 | |
Secondary | Verbal fluencies | Both semantic and phonological verbal fluencies were assessed in a quiet room. Semantic fluency was measured by asking patients to provide as many animal names as possible in 120 s. Different kinds of one sort of animal were accepted (e.g. kinds of birds or fish). Phonological fluency was measured by asking patients to provide as many words as possible beginning with the letter 'P' in 120 s. They were informed that proper nouns and words with the same stem would not be counted (e.g. pen, pencil). Patients were instructed to avoid repetitions. | 7 days | |
Secondary | Verbal fluencies | Both semantic and phonological verbal fluencies were assessed in a quiet room. Semantic fluency was measured by asking patients to provide as many animal names as possible in 120 s. Different kinds of one sort of animal were accepted (e.g. kinds of birds or fish). Phonological fluency was measured by asking patients to provide as many words as possible beginning with the letter 'P' in 120 s. They were informed that proper nouns and words with the same stem would not be counted (e.g. pen, pencil). Patients were instructed to avoid repetitions. | 21 days | |
Secondary | Verbal fluencies | Both semantic and phonological verbal fluencies were assessed in a quiet room. Semantic fluency was measured by asking patients to provide as many animal names as possible in 120 s. Different kinds of one sort of animal were accepted (e.g. kinds of birds or fish). Phonological fluency was measured by asking patients to provide as many words as possible beginning with the letter 'P' in 120 s. They were informed that proper nouns and words with the same stem would not be counted (e.g. pen, pencil). Patients were instructed to avoid repetitions. | 28 days | |
Secondary | Verbal fluencies | Both semantic and phonological verbal fluencies were assessed in a quiet room. Semantic fluency was measured by asking patients to provide as many animal names as possible in 120 s. Different kinds of one sort of animal were accepted (e.g. kinds of birds or fish). Phonological fluency was measured by asking patients to provide as many words as possible beginning with the letter 'P' in 120 s. They were informed that proper nouns and words with the same stem would not be counted (e.g. pen, pencil). Patients were instructed to avoid repetitions. | up to one year | |
Secondary | Symbol Digit Modalities Test | The SDMT has a key at the top of the page with numbers and symbols; participants are required to refer to the key to correctly decode several lines of symbols. After completing sample items correctly, participants are timed for 90 s and the total number correct is their raw score. Only correct answers were account to the final score. | Day 1 | |
Secondary | Symbol Digit Modalities Test | The SDMT has a key at the top of the page with numbers and symbols; participants are required to refer to the key to correctly decode several lines of symbols. After completing sample items correctly, participants are timed for 90 s and the total number correct is their raw score. Only correct answers were account to the final score. | 7 days | |
Secondary | Symbol Digit Modalities Test | The SDMT has a key at the top of the page with numbers and symbols; participants are required to refer to the key to correctly decode several lines of symbols. After completing sample items correctly, participants are timed for 90 s and the total number correct is their raw score. Only correct answers were account to the final score. | 21 days | |
Secondary | Symbol Digit Modalities Test | The SDMT has a key at the top of the page with numbers and symbols; participants are required to refer to the key to correctly decode several lines of symbols. After completing sample items correctly, participants are timed for 90 s and the total number correct is their raw score. Only correct answers were account to the final score. | 28 days | |
Secondary | Symbol Digit Modalities Test | The SDMT has a key at the top of the page with numbers and symbols; participants are required to refer to the key to correctly decode several lines of symbols. After completing sample items correctly, participants are timed for 90 s and the total number correct is their raw score. Only correct answers were account to the final score. | up to one year | |
Secondary | Modified Fatigue Impact Scale (mFIS) | The FIS is a 40-item Standardized questionnaire validated for MS. For our study, we used the validated French version of the FIS in MS, called "EMIF-SEP". The EMIF-SEP is composed of 40 items organized into four dimensions (cognitive, physical, social role and psychological dimensions) with each items rated on a four point scale (4=it's always true, 3=it's sometimes true, 2=it's sometimes false, 1=it's always false) and the total fatigue scores are standardized from 0 (meaning no fatigue) to 100 (meaning high degree of fatigue). The forty items are divided into the four dimensions: cognitive (10 items), physical (14 items), social role (13 items) and psychological (4 items). Each dimension score was also standardized as a percentage like total score. | day 1 | |
Secondary | Modified Fatigue Impact Scale (mFIS) | The FIS is a 40-item Standardized questionnaire validated for MS. For our study, we used the validated French version of the FIS in MS, called "EMIF-SEP". The EMIF-SEP is composed of 40 items organized into four dimensions (cognitive, physical, social role and psychological dimensions) with each items rated on a four point scale (4=it's always true, 3=it's sometimes true, 2=it's sometimes false, 1=it's always false) and the total fatigue scores are standardized from 0 (meaning no fatigue) to 100 (meaning high degree of fatigue). The forty items are divided into the four dimensions: cognitive (10 items), physical (14 items), social role (13 items) and psychological (4 items). Each dimension score was also standardized as a percentage like total score. | 7 days | |
Secondary | Modified Fatigue Impact Scale (mFIS) | The FIS is a 40-item Standardized questionnaire validated for MS. For our study, we used the validated French version of the FIS in MS, called "EMIF-SEP". The EMIF-SEP is composed of 40 items organized into four dimensions (cognitive, physical, social role and psychological dimensions) with each items rated on a four point scale (4=it's always true, 3=it's sometimes true, 2=it's sometimes false, 1=it's always false) and the total fatigue scores are standardized from 0 (meaning no fatigue) to 100 (meaning high degree of fatigue). The forty items are divided into the four dimensions: cognitive (10 items), physical (14 items), social role (13 items) and psychological (4 items). Each dimension score was also standardized as a percentage like total score. | 21 days | |
Secondary | Modified Fatigue Impact Scale (mFIS) | The FIS is a 40-item Standardized questionnaire validated for MS. For our study, we used the validated French version of the FIS in MS, called "EMIF-SEP". The EMIF-SEP is composed of 40 items organized into four dimensions (cognitive, physical, social role and psychological dimensions) with each items rated on a four point scale (4=it's always true, 3=it's sometimes true, 2=it's sometimes false, 1=it's always false) and the total fatigue scores are standardized from 0 (meaning no fatigue) to 100 (meaning high degree of fatigue). The forty items are divided into the four dimensions: cognitive (10 items), physical (14 items), social role (13 items) and psychological (4 items). Each dimension score was also standardized as a percentage like total score. | 28 days | |
Secondary | Modified Fatigue Impact Scale (mFIS) | The FIS is a 40-item Standardized questionnaire validated for MS. For our study, we used the validated French version of the FIS in MS, called "EMIF-SEP". The EMIF-SEP is composed of 40 items organized into four dimensions (cognitive, physical, social role and psychological dimensions) with each items rated on a four point scale (4=it's always true, 3=it's sometimes true, 2=it's sometimes false, 1=it's always false) and the total fatigue scores are standardized from 0 (meaning no fatigue) to 100 (meaning high degree of fatigue). The forty items are divided into the four dimensions: cognitive (10 items), physical (14 items), social role (13 items) and psychological (4 items). Each dimension score was also standardized as a percentage like total score. | up to one year | |
Secondary | Fatigue Severity Scale (FSS) | The FSS is a method of evaluating fatigue in PwMS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus. The FSS is designed to differentiate fatigue from clinical depression because both share some of the same symptoms. The FSS questionnaire is composed of 9 statements related to patients' subjective perception of fatigue and its consequences on everyday activities. Patients are asked to rate their level of agreement (toward 7) or disagreement (toward 0) with the 9 statements. | day 1 | |
Secondary | Fatigue Severity Scale (FSS) | The FSS is a method of evaluating fatigue in PwMS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus. The FSS is designed to differentiate fatigue from clinical depression because both share some of the same symptoms. The FSS questionnaire is composed of 9 statements related to patients' subjective perception of fatigue and its consequences on everyday activities. Patients are asked to rate their level of agreement (toward 7) or disagreement (toward 0) with the 9 statements. | 7 days | |
Secondary | Fatigue Severity Scale (FSS) | The FSS is a method of evaluating fatigue in PwMS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus. The FSS is designed to differentiate fatigue from clinical depression because both share some of the same symptoms. The FSS questionnaire is composed of 9 statements related to patients' subjective perception of fatigue and its consequences on everyday activities. Patients are asked to rate their level of agreement (toward 7) or disagreement (toward 0) with the 9 statements. | 21 days | |
Secondary | Fatigue Severity Scale (FSS) | The FSS is a method of evaluating fatigue in PwMS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus. The FSS is designed to differentiate fatigue from clinical depression because both share some of the same symptoms. The FSS questionnaire is composed of 9 statements related to patients' subjective perception of fatigue and its consequences on everyday activities. Patients are asked to rate their level of agreement (toward 7) or disagreement (toward 0) with the 9 statements. | 28 days | |
Secondary | Fatigue Severity Scale (FSS) | The FSS is a method of evaluating fatigue in PwMS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus. The FSS is designed to differentiate fatigue from clinical depression because both share some of the same symptoms. The FSS questionnaire is composed of 9 statements related to patients' subjective perception of fatigue and its consequences on everyday activities. Patients are asked to rate their level of agreement (toward 7) or disagreement (toward 0) with the 9 statements. | up to one year | |
Secondary | Multiple Sclerosis Walking Scale 12 (MSWS12) | The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. | day 1 | |
Secondary | Multiple Sclerosis Walking Scale 12 (MSWS12) | The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. | 7 days | |
Secondary | Multiple Sclerosis Walking Scale 12 (MSWS12) | The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. | 21 days | |
Secondary | Multiple Sclerosis Walking Scale 12 (MSWS12) | The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. | 28 days | |
Secondary | Multiple Sclerosis Walking Scale 12 (MSWS12) | The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. | up to one year | |
Secondary | "PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) | The PERSEPP scale was used to evaluate the HRQoL of patients with MS (Baroin et al. 2013). This scale takes into account several aspects of HRQoL distributed across 66 items (described below) and includes relapse phases. Each item contains 6 response types according to a Likert scale where "0" was "strongly disagree" and "5" was "strongly agree". The PERSEPP scale has been validated in the French language | day 1 | |
Secondary | "PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) | The PERSEPP scale was used to evaluate the HRQoL of patients with MS (Baroin et al. 2013). This scale takes into account several aspects of HRQoL distributed across 66 items (described below) and includes relapse phases. Each item contains 6 response types according to a Likert scale where "0" was "strongly disagree" and "5" was "strongly agree". The PERSEPP scale has been validated in the French language | day 7 | |
Secondary | "PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) | The PERSEPP scale was used to evaluate the HRQoL of patients with MS (Baroin et al. 2013). This scale takes into account several aspects of HRQoL distributed across 66 items (described below) and includes relapse phases. Each item contains 6 response types according to a Likert scale where "0" was "strongly disagree" and "5" was "strongly agree". The PERSEPP scale has been validated in the French language | day 21 | |
Secondary | "PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) | The PERSEPP scale was used to evaluate the HRQoL of patients with MS (Baroin et al. 2013). This scale takes into account several aspects of HRQoL distributed across 66 items (described below) and includes relapse phases. Each item contains 6 response types according to a Likert scale where "0" was "strongly disagree" and "5" was "strongly agree". The PERSEPP scale has been validated in the French language | day 28 | |
Secondary | "PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) | The PERSEPP scale was used to evaluate the HRQoL of patients with MS (Baroin et al. 2013). This scale takes into account several aspects of HRQoL distributed across 66 items (described below) and includes relapse phases. Each item contains 6 response types according to a Likert scale where "0" was "strongly disagree" and "5" was "strongly agree". The PERSEPP scale has been validated in the French language | up to one year | |
Secondary | Physical activity in real life condition | The physical activity in real-life condition was measured with an ActiGraph, model wGT3X (Actigraph corp, USA), consistent with previous research on validating accelerometer output in PwMS. The accelerometer was sampled at 30 Hz and values were expressed as number of counts per minute. Participants were instructed to wear the accelerometer on an elastic belt around the waist (i.e. near to the center of displacement of body mass) located above the hip at the non-dominant side ; to wear it for a 7-day period (including a weekend); and to wear it for the whole day from getting out of bed in the morning until getting into bed in the evening. These instructions were summarized in a memo and given to participants. | During 7 days (day 1 to day 7) | |
Secondary | Physical activity in real life condition | The physical activity in real-life condition was measured with an ActiGraph, model wGT3X (Actigraph corp, USA), consistent with previous research on validating accelerometer output in PwMS. The accelerometer was sampled at 30 Hz and values were expressed as number of counts per minute. Participants were instructed to wear the accelerometer on an elastic belt around the waist (i.e. near to the center of displacement of body mass) located above the hip at the non-dominant side ; to wear it for a 7-day period (including a weekend); and to wear it for the whole day from getting out of bed in the morning until getting into bed in the evening. These instructions were summarized in a memo and given to participants. | During 7 days (day 21 to day 28) | |
Secondary | Timed 25 Walk Test (T25WT) | According with the recommendation of Cutter et al., participants were asked to walk on a 25 feet (7.62 m) distance. After appropriate instructions and familiarization, participants were asked to perform three gait tasks: walking at their self-selected comfortable speed . | Day 1 | |
Secondary | Timed 25 Walk Test (T25WT) | According with the recommendation of Cutter et al., participants were asked to walk on a 25 feet (7.62 m) distance. After appropriate instructions and familiarization, participants were asked to perform three gait tasks: walking at their self-selected comfortable speed . | 7 days | |
Secondary | Timed 25 Walk Test (T25WT) | According with the recommendation of Cutter et al., participants were asked to walk on a 25 feet (7.62 m) distance. After appropriate instructions and familiarization, participants were asked to perform three gait tasks: walking at their self-selected comfortable speed . | 21 days | |
Secondary | Timed 25 Walk Test (T25WT) | According with the recommendation of Cutter et al., participants were asked to walk on a 25 feet (7.62 m) distance. After appropriate instructions and familiarization, participants were asked to perform three gait tasks: walking at their self-selected comfortable speed . | 28 days | |
Secondary | Timed 25 Walk Test (T25WT) | According with the recommendation of Cutter et al., participants were asked to walk on a 25 feet (7.62 m) distance. After appropriate instructions and familiarization, participants were asked to perform three gait tasks: walking at their self-selected comfortable speed . | up to one year | |
Secondary | Timed Up and Go test (TUG) | The TUG is a clinical test to assess the level of gait and balance. For its realization, a 47-cm-high chair with arm- and backrest was used. The 3-meters distance was marked with a tape on the floor and a cone marked the turning point. Participants were instructed to get up from the chair, walk 3 meters, turn around the cone and come back to sit on the chair. Participants were encouraged to walk as quickly as possible with safety consistency. After a familiarization trial, the TUG was performed twice. A third trial was applied if a difference of 10% was found between the two first trials. The mean value computed from the two closest trials was taken into account. | Day 1 | |
Secondary | Timed Up and Go test (TUG) | The TUG is a clinical test to assess the level of gait and balance. For its realization, a 47-cm-high chair with arm- and backrest was used. The 3-meters distance was marked with a tape on the floor and a cone marked the turning point. Participants were instructed to get up from the chair, walk 3 meters, turn around the cone and come back to sit on the chair. Participants were encouraged to walk as quickly as possible with safety consistency. After a familiarization trial, the TUG was performed twice. A third trial was applied if a difference of 10% was found between the two first trials. The mean value computed from the two closest trials was taken into account. | 7 days | |
Secondary | Timed Up and Go test (TUG) | The TUG is a clinical test to assess the level of gait and balance. For its realization, a 47-cm-high chair with arm- and backrest was used. The 3-meters distance was marked with a tape on the floor and a cone marked the turning point. Participants were instructed to get up from the chair, walk 3 meters, turn around the cone and come back to sit on the chair. Participants were encouraged to walk as quickly as possible with safety consistency. After a familiarization trial, the TUG was performed twice. A third trial was applied if a difference of 10% was found between the two first trials. The mean value computed from the two closest trials was taken into account. | 21 | |
Secondary | Timed Up and Go test (TUG) | The TUG is a clinical test to assess the level of gait and balance. For its realization, a 47-cm-high chair with arm- and backrest was used. The 3-meters distance was marked with a tape on the floor and a cone marked the turning point. Participants were instructed to get up from the chair, walk 3 meters, turn around the cone and come back to sit on the chair. Participants were encouraged to walk as quickly as possible with safety consistency. After a familiarization trial, the TUG was performed twice. A third trial was applied if a difference of 10% was found between the two first trials. The mean value computed from the two closest trials was taken into account. | 28 days | |
Secondary | Timed Up and Go test (TUG) | The TUG is a clinical test to assess the level of gait and balance. For its realization, a 47-cm-high chair with arm- and backrest was used. The 3-meters distance was marked with a tape on the floor and a cone marked the turning point. Participants were instructed to get up from the chair, walk 3 meters, turn around the cone and come back to sit on the chair. Participants were encouraged to walk as quickly as possible with safety consistency. After a familiarization trial, the TUG was performed twice. A third trial was applied if a difference of 10% was found between the two first trials. The mean value computed from the two closest trials was taken into account. | up to one year | |
Secondary | 6 Minute Walk Test (6MWT) | The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds. | day 1 | |
Secondary | 6 Minute Walk Test (6MWT) | The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds. | day 7 | |
Secondary | 6 Minute Walk Test (6MWT) | The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds. | day 28 | |
Secondary | 6 Minute Walk Test (6MWT) | The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds. | up to one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |