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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05385731
Other study ID # MUSCLE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2, 2022
Est. completion date December 30, 2024

Study information

Verified date May 2022
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to analyze the effects of Nordic Walking and free walking in the clinical-functional, postural balance, motor control, muscular echographic quality, and gait analysis (pendulum gait mechanism), in people with Multiple Sclerosis.


Description:

Objective: Analyze the effects of Nordic Walking and free walking in the clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, in people with Multiple sclerosis. Experimental Design: Randomized controlled multicenter clinical trial with translational study characteristics. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Brazil, and University of Pavia, on Department of Public Health, Experimental Medicine and Forensic Sciences, Pavia, Italy. Participants: 60 patients from the Unified Health System (UHS) of both sexes, from 20 to 75 years old, diagnosed with multiple sclerosis, sedentary. Interventions: In this research, four groups of patients with multiple sclerosis will receive intervention during 4 months of different physical therapy programs (Nordic walking and free walking), who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 3 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. To evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session. Outcomes: clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, and biochemistry. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: The intervention groups of the Nordic walking are expected to be more effective in all outcomes analyzed, especially improving functional mobility when compared to the control group of unsupervised home exercises. In addition, it is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social, and environmental fields and that they will be implemented in the Unified Health System (UHS).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 30, 2024
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - volunteers aged over 20 years; - of both sexes; - with a clinical diagnosis of multiple sclerosis. Exclusion Criteria: - severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker; - stroke or other associated neurological diseases; insanity; - prostheses in the lower limbs; - without ambulation conditions.

Study Design


Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Chronic Progressive
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Secondary Progressive
  • Sclerosis

Intervention

Other:
Nordic Walking (NWG)
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Free Walking (FWG)
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Health Education (HEG)
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Sul Porto Alegre Rio Grande Do Sul

Sponsors (3)

Lead Sponsor Collaborator
Leonardo A. Peyré-Tartaruga Aline Nogueira Haas, Flávia Gomes Martinez

Country where clinical trial is conducted

Brazil, 

References & Publications (46)

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Balbinot G, Schuch CP, Bianchi Oliveira H, Peyré-Tartaruga LA. Mechanical and energetic determinants of impaired gait following stroke: segmental work and pendular energy transduction during treadmill walking. Biol Open. 2020 Jul 21;9(7). pii: bio051581. doi: 10.1242/bio.051581. — View Citation

Boeschoten RE, Braamse AMJ, Beekman ATF, Cuijpers P, van Oppen P, Dekker J, Uitdehaag BMJ. Prevalence of depression and anxiety in Multiple Sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2017 Jan 15;372:331-341. doi: 10.1016/j.jns.2016.11 — View Citation

Casal MZ, Peyré-Tartaruga LA, Zanardi APJ, Ivaniski-Mello A, Alves LL, Haas AN, Martinez FG. Postural Adjustments and Biomechanics During Gait Initiation and Obstacle Negotiation: A Comparison Between Akinetic-Rigid and Hyperkinetic Parkinson's Disease. F — View Citation

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Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain. 2003 Apr;126(Pt 4):770-82. — View Citation

Correale L, Buzzachera CF, Liberali G, Codrons E, Mallucci G, Vandoni M, Montomoli C, Bergamaschi R. Effects of Combined Endurance and Resistance Training in Women With Multiple Sclerosis: A Randomized Controlled Study. Front Neurol. 2021 Aug 5;12:698460. doi: 10.3389/fneur.2021.698460. eCollection 2021. — View Citation

Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50. — View Citation

Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyré-Tartaruga LA, Haas AN. Can Samba and Forró Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y. — View Citation

Frazzitta G, Balbi P, Maestri R, Bertotti G, Boveri N, Pezzoli G. The beneficial role of intensive exercise on Parkinson disease progression. Am J Phys Med Rehabil. 2013 Jun;92(6):523-32. doi: 10.1097/PHM.0b013e31828cd254. Review. — View Citation

Gomeñuka NA, Bona RL, da Rosa RG, Peyré-Tartaruga LA. The pendular mechanism does not determine the optimal speed of loaded walking on gradients. Hum Mov Sci. 2016 Jun;47:175-185. doi: 10.1016/j.humov.2016.03.008. Epub 2016 Mar 24. — View Citation

Gomeñuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodríguez Paz MC, Pellegrini B, Peyré-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6. — View Citation

Gulde P, Hermsdörfer J, Rieckmann P. Speed but Not Smoothness of Gait Reacts to Rehabilitation in Multiple Sclerosis. Mult Scler Int. 2021 Jun 3;2021:5589562. doi: 10.1155/2021/5589562. eCollection 2021. — View Citation

Halabchi F, Alizadeh Z, Sahraian MA, Abolhasani M. Exercise prescription for patients with multiple sclerosis; potential benefits and practical recommendations. BMC Neurol. 2017 Sep 16;17(1):185. doi: 10.1186/s12883-017-0960-9. 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

Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23. — View Citation

Kelleher KJ, Spence W, Solomonidis S, Apatsidis D. The characterisation of gait patterns of people with multiple sclerosis. Disabil Rehabil. 2010;32(15):1242-50. doi: 10.3109/09638280903464497. — View Citation

Kim Y, Lai B, Mehta T, Thirumalai M, Padalabalanarayanan S, Rimmer JH, Motl RW. Exercise Training Guidelines for Multiple Sclerosis, Stroke, and Parkinson Disease: Rapid Review and Synthesis. Am J Phys Med Rehabil. 2019 Jul;98(7):613-621. doi: 10.1097/PHM — View Citation

Kuo AD, Donelan JM. Dynamic principles of gait and their clinical implications. Phys Ther. 2010 Feb;90(2):157-74. doi: 10.2522/ptj.20090125. Epub 2009 Dec 18. Review. — View Citation

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. — View Citation

Leal-Nascimento AH, da Silva ES, Zanardi APJ, Ivaniski-Mello A, Passos-Monteiro E, Martinez FG, Rodrigo de Carvalho A, Baptista RR, Peyré-Tartaruga LA. Biomechanical responses of Nordic walking in people with Parkinson's disease. Scand J Med Sci Sports. 2 — View Citation

Martínez-Lemos I, Martínez-Aldao D, Seijo-Martínez M, Ayán C. Nordic walking for people with relapsing-remittent multiple sclerosis: A case series study. Mult Scler Relat Disord. 2020 Nov;46:102479. doi: 10.1016/j.msard.2020.102479. Epub 2020 Sep 3. — View Citation

MONTEIRO, Elren Passos et al. Aspectos biomecânicos da locomoção de pessoas com doença de Parkinson: revisão narrativa. Revista Brasileira de Ciências do Esporte, v. 39, p. 450-457, 2017.

Motl RW, Sandroff BM. Benefits of Exercise Training in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2015 Sep;15(9):62. doi: 10.1007/s11910-015-0585-6. Review. — View Citation

Nardello F, Ardigò LP, Minetti AE. Measured and predicted mechanical internal work in human locomotion. Hum Mov Sci. 2011 Feb;30(1):90-104. doi: 10.1016/j.humov.2010.05.012. Epub 2010 Nov 5. — View Citation

Nogueira LA, Teixeira L, Sabino P, Filho HA, Alvarenga RM, Thuler LC. Gait characteristics of multiple sclerosis patients in the absence of clinical disability. Disabil Rehabil. 2013 Aug;35(17):1472-8. doi: 10.3109/09638288.2012.738760. — View Citation

O'CONNELL, R. et al. A controlled study to assess the effects of aerobic training on patients with multiple sclerosis. 14th International World Confederation for Physical Therapy, 2003.

Passos-Monteiro E, B Schuch F, T Franzoni L, R Carvalho A, A Gomeñuka N, Becker M, Rieder CRM, Andrade A, G Martinez F, S Pagnussat A, A Peyré-Tartaruga L. Nordic Walking and Free Walking Improve the Quality of Life, Cognitive Function, and Depressive Symptoms in Individuals with Parkinson's Disease: A Randomized Clinical Trial. J Funct Morphol Kinesiol. 2020 Nov 10;5(4). pii: E82. doi: 10.3390/jfmk5040082. — View Citation

Patti F, Ciancio MR, Cacopardo M, Reggio E, Fiorilla T, Palermo F, Reggio A, Thompson AJ. Effects of a short outpatient rehabilitation treatment on disability of multiple sclerosis patients--a randomised controlled trial. J Neurol. 2003 Jul;250(7):861-6. — View Citation

Peyré-Tartaruga LA, Dewolf AH, di Prampero PE, Fábrica G, Malatesta D, Minetti AE, Monte A, Pavei G, Silva-Pereyra V, Willems PA, Zamparo P. Mechanical work as a (key) determinant of energy cost in human locomotion: recent findings and future directions. — View Citation

Peyré-Tartaruga LA, Martinez FG, Zanardi APJ, Casal MZ, Donida RG, Delabary MS, Passos-Monteiro E, Coertjens M, Haas AN. Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. Sport Sci Health. 2022 Feb 17:1-9. doi: 10.1007/s11332-022-00894-4. [Epub ahead of print] Review. — View Citation

Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366. — View Citation

Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 — View Citation

Psarakis M, Greene D, Moresi M, Baker M, Stubbs P, Brodie M, Lord S, Hoang P. Impaired heel to toe progression during gait is related to reduced ankle range of motion in people with Multiple Sclerosis. Clin Biomech (Bristol, Avon). 2017 Nov;49:96-100. doi: 10.1016/j.clinbiomech.2017.08.012. Epub 2017 Sep 1. — View Citation

Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30. — View Citation

Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003980. Review. — View Citation

Saibene F, Minetti AE. Biomechanical and physiological aspects of legged locomotion in humans. Eur J Appl Physiol. 2003 Jan;88(4-5):297-316. Epub 2002 Nov 13. Review. — View Citation

Schepens B, Bastien GJ, Heglund NC, Willems PA. Mechanical work and muscular efficiency in walking children. J Exp Biol. 2004 Feb;207(Pt 4):587-96. — View Citation

SOARES, Gustavo da Silva; PEYRÉ-TARTARUGA, Leonardo Alexandre. Doença de Parkinson e exercício físico: uma revisão da literatura. Ciência em Movimento, v. 12, n. 24, p. 69-85, 2010.

Tschentscher M, Niederseer D, Niebauer J. Health benefits of Nordic walking: a systematic review. Am J Prev Med. 2013 Jan;44(1):76-84. doi: 10.1016/j.amepre.2012.09.043. Review. — View Citation

WILLEMS, P.-A.; SCHEPENS, Bénédicte; DETREMBLEUR, Christine. Marcha normal. EMC-Kinesiterapia-Medicina Física, v. 33, n. 2, p. 1-29, 2012.

YASINSKAYA, Yana Konstantinovna. DEVELOPMENT OF STATIC AND DYNAMIC BALANCE IN INDIVIDUALS WITH MULTIPLE SCLEROSIS BASED ON THE USE OF THE NORDIC WALKING METHOD. ????? ?? ????????, n. 12, p. 320, 2014.

Zanardi APJ, da Silva ES, Costa RR, Passos-Monteiro E, Dos Santos IO, Kruel LFM, Peyré-Tartaruga LA. Gait parameters of Parkinson's disease compared with healthy controls: a systematic review and meta-analysis. Sci Rep. 2021 Jan 12;11(1):752. doi: 10.1038/s41598-020-80768-2. — View Citation

Zigmond MJ, Smeyne RJ. Exercise: is it a neuroprotective and if so, how does it work? Parkinsonism Relat Disord. 2014 Jan;20 Suppl 1:S123-7. doi: 10.1016/S1353-8020(13)70030-0. Review. — View Citation

* Note: There are 46 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Balance Dynamics Balance Dynamics: This outcome will be evaluated using Berg Balance Scale (BBS). This scale assessment of the individual's balance in 14 situations, representative of activities of the day to day, such as: stand up, get up, walk, to lean forward, to move, to turn, among others. The maximum score of a being reached of 56 points and each item has an ordinal scale of five alternatives ranging from 0 to 4 points, according to the degree of difficulty. Change from baseline at 12 weeks
Other Balance Static Balance Static: This outcome will be evaluated using area of center of pressure (cm squared). Change from baseline at 12 weeks
Other Stride length Stride Length (in meters). This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed (in kilometers/hours). Change from baseline at 12 weeks
Other Dynamics Stability This outcome is calculated as the inter-strides variation in terms of coefficient of variation of stride frequency. Change from baseline at 12 weeks
Other Electromyographic activity This outcome is measure is the mean amplitude (in millivolts) of the muscles: vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph. In of the walking test on treadmill at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed. Change from baseline at 12 weeks
Other Motor behavior by electromyographic activity During the gait initiation, the investigators will evaluate the anticipatory postural adjustments. The electromyograph will be used to obtain electromyographic activity data of the spinal erector muscles, internal oblique, gluteus medius, rectus femoris, femoral biceps, medial gastrocnemius and tibialis anterior (in mV).
All these parameters will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other Muscular activation Muscular activation:Muscular activation during phases of the gait cycle of people with Parkinson's disease through the electromyographic evaluation of the muscles of the spinal erector, internal oblique, gluteus medius, rectus femoris, femoral biceps, anterior tibialis and medial gastrocnemius during treadmill running. All participants will walk on a treadmill at selected walking speed. To identify electromyographic activity during the different gait cycles, the electromyograph will be synchronized with VICON (Vicon Motion Capture System - Oxford - USA, 1984).
All these parameters will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other Internal Work The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
All these parameters will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other External Work The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
All these parameters will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other total mechanical work The total mechanical work (Wtot =Wext + Wint) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
All these parameters will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other Pendulum-like Recovery The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
This parameter will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other Scapular and pelvis coordination The scapular girdle movement in angles will be measure, pelvic girdle in angles will be measure.
The scapular girdle movement in angles will be aggregated to pelvic girdle in angles to arrive at continuous phases relation in angle.
This parameter will be measured before and after Nordic and free walking interventions.
Change from baseline at 12 weeks
Other Range of motion Range of motion (in degrees) of the following segments and joints: Tilt pelvic, sagittal flexion of trunk, hip flexion, knee flexion, ankle flexion, shoulder flexion, shoulder abduction, elbow flexion. All these parameters will be measured before and after Nordic and free walking interventions. Change from baseline at 12 weeks
Other Psychological parameters - Profile of Mood State This variable will be measure by the Brunel Mood Scale (BRUMS) that was developed to provide a quick assessment of mood states adult populations. The BRUMS has been demonstrated to have Cronbach alpha values above 0.70 and is a reliable tool used to measure the mood of Brazilian athletes. The instrument consisted of 24 items and six subscales assessing mood: tension, depression, anger, vigor, fatigue and confusion.
Each item was rated on a Likert scale ranging from nothing (0) to extremely (4), where the respondent indicated how they were feeling at that moment. The results were calculated using the mean of the items in each subscale.
Change from baseline at 12 weeks
Other Quality of sleep - The Pittsburgh Sleep Quality Index (PSQI) The PSQI consists of 24 questions or items to be rated (0-3 for 20 items while 4 items are open-ended), 19 of which are self-reported and 5 of which require secondary feedback from a room or bed partner. Only the self-reported items (15 rated as 0-3 while 4 open-ended) are used for quantitative evaluation of sleep quality as perceived by the patient. The open-ended items are also finally scored as structured categorical values (rated at 0-3) as per the range of values reported for them by the patient. These 19 self-reported items are used to generate categorical scores representing the PSQI's 7 components. The individual component scores each assess a specific feature of sleep. Finally, the scores for each component are summed to get a total score, also termed the global score (range: 0 to 21). This score provides a summary of the respondent's sleep experience and quality for the past month. Change from baseline at 12 weeks
Primary Test Timed Up and Go Test Timed Up and Go: This test evaluates the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS) [Time Frame: Change from baseline at 12 weeks] Change from baseline at 12 weeks
Primary Locomotor Rehabilitation Index The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt). Change from baseline at 12 weeks
Primary Self-selected walking speed SSWS This outcome will be measure in test of treadmill walking Change from baseline at 12 weeks
Secondary Optimal Walking Speed (OPT) Optimal Walking Speed (OPT) This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill. Change from baseline at 12 weeks
Secondary Quality of life (QoL) Quality of life (QoL) The quality of life will be estimated using the World Health Organization Quality of Life. (WHOQOL-short domains: physical, psychological, social relationships, environment, and general quality of life) and (WHOQOL-Long domains: sensory abilities, autonomy, Past. Present and Future Activities, social participation, death and dying, intimacy, and general quality of life). Change from baseline at 12 weeks
Secondary Cognitive function Cognitive function This outcome will be measure for Montreal Cognitive Assessment (MoCA). Change from baseline at 12 weeks
Secondary Depressive symptoms This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms. Change from baseline at 12 weeks
Secondary Expanded Disability Status Scale The Expanded Disability Status Scale is the most appropriate to assess evolution and point to a new relapse. The Expanded Disability Status Scale has been the most commonly used. It has twenty items with scores ranging from 0 to 10, with the score increasing by half a point according to the patient's degree of disability, giving more focus on the patient's ability to walk (especially in scores above 4.0). Change from baseline at 12 weeks
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