[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608487":3},{"organization":4,"outcomesModule":7,"designInfo":101,"detailedDescription":104,"studyPopulation":104,"armGroups":111,"interventions":123,"overallOfficials":139,"centralContacts":143,"locations":151,"responsibleParty":190,"collaborators":193,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":201,"sex":207,"minAge":208,"maxAge":104,"enrollmentInfo":209,"targetDuration":104,"studyType":212,"phases":213,"briefSummary":215,"conditions":216,"keywords":225,"overallStatus":154,"whyStopped":104,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":68},[9],{"measure":10,"description":11,"timeFrame":12},"NHPT+SSST score","The primary outcome will be a combined measure of upper and lower extremity motor function, consisting of the Nine Hole Peg Test and the Six Spot step test (labelled NHPT+SSST score). Values are expressed in seconds.\n\nA higher score, indicates a worse outcome.","After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.",[14,18,22,26,30,34,38,41,45,49,53,57,61,65],{"measure":15,"description":16,"timeFrame":17},"Six spot step test (SSST)","Similar to the T25FW, the SSST is a quantitative measure of lower extremity function. The test contains a rectangular field with six circles on the floor following a criss-cross course. Five circles contain a block. The starting-point is the first circle, which does not contain a block. From there the patient walks to the other side of the field and kicks the blocks out of the five circles, as quickly as possible. The task is immediately administered again by having the patient walk back the same route. Both the dominant and non-dominant legs are tested twice.\n\nThe Maximum value: 300.0 seconds A higher score indicates a worse outcome.","SSST assessment will take place after weeks 1 and 6 of stimulation.",{"measure":19,"description":20,"timeFrame":21},"Nine Hole Peg Test (NHPT)","The Nine-Hole Peg Test (NHPT) is an assessment tool used to evaluate movement speed, particularly fine hand motor skills. The patient must take nine pegs from a container as quickly as possible and place them into the holes on a board. Afterwards, the patient must remove the pegs and return them to the container. The time taken to complete the task is measured. The patient may only use the hand being tested and must repeat the procedure for each peg individually (they are not allowed to pick up multiple pegs at once).\n\nA higher score indicates a worse outcome.","NHPT assessment will take place after weeks 1 and 6 of stimulation.",{"measure":23,"description":24,"timeFrame":25},"Modified Ashworth Scale (MAS)","The Modified Ashworth Scale (MAS) is designed to objectively assess the degree of spasticity. The MAS measures the level of hypertonia in the left and right elbows and knees. The therapist evaluates the muscle tone and records the highest level of tone felt during five repetitions per joint, using a six-point scale (0 = no increase in muscle tone, 4 = limb rigid in flexion or extension and cannot be moved).\n\nA higher score indicates a worse outcome.","MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.",{"measure":27,"description":28,"timeFrame":29},"Scale for the Assessment and Rating of Ataxia (SARA)","SARA is a clinical scale which assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.\n\nThe minimum value: 0 The maximum value: 40 A higher score indicates a worse outcome.","SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.",{"measure":31,"description":32,"timeFrame":33},"Numeric Rating Scale (NRS)","The severity of ataxia and spasticity will be documented bij a numeric scale. The minimum value: 0 The maximum value: 10 A higher score indicates a worse outcome.","NRS assessments will take place after weeks 1 and 6 of stimulation.",{"measure":35,"description":36,"timeFrame":37},"6 Minute walk test","The goal is for the participant to walk as many meters as possible within 6 minutes over a 30-meter course. The participant may use walking aids or foot orthoses. This test assesses the participant's functional capacity. The more meters walked, the better the functional capacity.","The assessment will take place after weeks 1 and 6 of stimulation.",{"measure":39,"description":40,"timeFrame":37},"5 times sit to stand test (5STS)","De Timed Chair Stand Test is a simple evaluative test used to assess, among other things, muscle strength, balance, and fall risk in older adults. During the Timed Chair Stand Test, the patient is asked to stand up from a chair and sit down again five times as quickly as possible, without using the arms. The physiotherapist records the time in seconds. A score greater than 14s indicates a fall risk.",{"measure":42,"description":43,"timeFrame":44},"The patient-Determined Disease Steps (PDDS)","A questionnaire on how a person with MS preceives their capacity to walk. The patient needs to chose one descrition the reflects their condition the best.\n\nThe minimum value: 0 The maximum value: 8 A higher score, indicates a worse outcome.","PDDS assessment will take place after weeks 1 and 6 of stimulation.",{"measure":46,"description":47,"timeFrame":48},"The 12-item Multiple Sclerosis Walking Scale (MSWS12)","The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.\n\nThe minimum value: 0 The maximum value: 100 A higher score, indicate a worse outcome.","MSWS-12 assessment will take place after weeks 1 and 6 of stimulation.",{"measure":50,"description":51,"timeFrame":52},"The 36-item Manual Ability Measurement (MAM36)","The Manual Ability Measure (MAM) is designed as an outcome instrument to assess hand function based on the patient's responses to functional questions. Tasks are rated on a scale from 0 (cannot be done) to 4 (easy to do). Total scores range from 0 to 144.\n\nA higher score indicates greater perceived manual ability.","MAM36 assessment will take place after weeks 1 and 6 of stimulation.",{"measure":54,"description":55,"timeFrame":56},"The EuroQol Questionnaire (EQ-D5)","The EQ-5D is a standardized instrument that provides a score across five health dimensions: mobility, self-care, daily activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. (5 items, three or five response categories) In addition, the patient must indicate how they perceive their overall health status on a scale from 0 to 100. To interpret the results correctly, it is important that the healthcare provider is familiar with the patient's demographic information. (8 items) A higher score indicates a worse outcome.","EQ-5D assessment will take place after weeks 1 and 6 of stimulation.",{"measure":58,"description":59,"timeFrame":60},"adapted Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM 1.4)","Is used to evaluate treatment satisfaction with the particular aim of development and evaluation of treatment satisfaction among the patients already undergoing treatment. TSQM (1.4) has 14 questions divided into 4 subscales: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). Higher scores indicate a higher patient satisfaction with medication (Liberato et al. 2020). The questions have been re-formulated so they are applicable to using the stimulation suit.","The adapted TSQM 1.4 assessment will take place after weeks 1 and 6 of stimulation. Only for the intervention group",{"measure":62,"description":63,"timeFrame":64},"SymptoMScreen","A tool for rapid assessment of MS symptom ( the six most common areas where symptomatic complaints occur and are discussed during clinical visits) severity in routine clinical practice. It uses a 7-point Likert scales for each functional domain (0 = not affected at all, 6 = total limitation\u002FI'm unable to do most daily activities).\n\nThe minimum value: 0 The maximum value: 72 A higher score indicates a worse outcome.","SymptoMScreen assessment will take place weekly from the start of the intervention until end of the study.",{"measure":66,"description":67,"timeFrame":37},"Modified Fatigue Impact Scales (MFIS)","The assessment will be used to assess the physical, cognitive, and psychosocial impact of fatigue. Each of the 21 items of the MFIS will be scored from 0-to-4, providing a total score ranging from 0 to 84 (higher scores, greater fatigue impact).",[69,73,77,80,83,86,89,92,95,98],{"measure":70,"description":71,"timeFrame":72},"Multiple Sclerosis (MS) type","MS type: primary progressive (PP), secundary progressive (SP), relapsing remitting (RR), ..","Will be collected (at baseline) when a partcipant is found eligible",{"measure":74,"description":75,"timeFrame":76},"age","Age (years)","Will be collected at baseline when a partcipant is found eligible",{"measure":78,"description":79,"timeFrame":76},"sex","sex (m\u002Fv)",{"measure":81,"description":82,"timeFrame":76},"height","height (cm)",{"measure":84,"description":85,"timeFrame":76},"weight","weight (kg),",{"measure":87,"description":88,"timeFrame":72},"Expanded Disability Status Score (EDSS)","latest EDSS: The Expanded Disability Status Scale measures your current level of disability.\n\nValues: (0.0 -10.0) A higher score indicates a worse outcome",{"measure":90,"description":91,"timeFrame":72},"Time since diagnosis","time since diagnosis (years)",{"measure":93,"description":94,"timeFrame":72},"Medication","Previous and current MS medication. previous and current ataxia or spasticity medication will be listed",{"measure":96,"description":97,"timeFrame":72},"Onset Spasticity and\u002For ataxia","Time since onset of ataxia or spasticity. (years)",{"measure":99,"description":100,"timeFrame":72},"Comorbidities","Comorbidities will be listed.",{"allocation":102,"interventionModel":103,"interventionModelDescription":104,"primaryPurpose":105,"observationalModel":104,"timePerspective":104,"maskingInfo":106},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":107,"maskingDescription":104,"whoMasked":108},"DOUBLE",[109,110],"INVESTIGATOR","OUTCOMES_ASSESSOR",[112,119],{"label":113,"type":114,"description":115,"interventionNames":116},"stimulation suit group","EXPERIMENTAL","This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care.",[117,118],"Device: electro-stimulation suit","Other: Usual Care",{"label":120,"type":6,"description":121,"interventionNames":122},"usual care","This group will be a comparator and have no added intervention expect for their usual care.",[118],[124,133],{"type":125,"name":126,"description":127,"armGroupLabels":128,"otherNames":129},"DEVICE","electro-stimulation suit","In EXOPULSE Mollii Suit is a multi-channel full-body suit with a low energy electrical stimulation - 20 Volt and 20 Hz. It generates 2 milliamp pulses (into 0-10,000 Ohms) with the following parameters:\n\n* Pulse width: variable between 25 and 170 μs.\n* Length of period: 50 ms.\n* Maximum amplitude: 20 V. It is composed of a control unit, a jacket and pants, with 58 embed-ded electrodes, in direct contact with the skin, and pre-positioned to stimulate 40 key muscle groups.\n\nThe suit comes in different sizes. A trained medical staff pre-programs which nerves\u002Fmuscles to be stimulated based on a clinical assessment of the user and the outcome is evaluated through standardized methods. The stimulation program is thus specific to each user.",[113],[130,131,132],"neuromodulation suit","stimulation suit","EXOPULSE MOLLII suit",{"type":6,"name":134,"description":135,"armGroupLabels":136,"otherNames":137},"Usual Care","The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced\u002Fadjusted to make time for initiation and follow-up of using the neuromodulation suit and potentially also during the weeks at home (i.e., rehabilitation being offered by municipalities).",[113,120],[138],"standard care",[140],{"name":141,"affiliation":5,"role":142},"Daphne Kos","PRINCIPAL_INVESTIGATOR",[144,148],{"name":141,"role":145,"phone":146,"phoneExt":104,"email":147},"CONTACT","+32496107849","daphne.kos@uzbrussel.be",{"name":149,"role":145,"phone":104,"phoneExt":104,"email":150},"Alix-Anne Schreinemacher","alix-anne.schreinemacher@mscenter.be",[152,175],{"facility":153,"status":154,"city":155,"state":104,"zip":156,"country":157,"countryCode":158,"cosmosGeoPoint":159,"geoPoint":164,"contacts":165},"Nationaal MS Center Melsbroek","RECRUITING","Steenokkerzeel","1820","Belgium","BE",{"type":160,"coordinates":161},"Point",[162,163],4.50989,50.91851,{"lat":163,"lon":162},[166,167,168,169,172,174],{"name":141,"role":145,"phone":146,"phoneExt":104,"email":147},{"name":149,"role":145,"phone":104,"phoneExt":104,"email":150},{"name":141,"role":142,"phone":104,"phoneExt":104,"email":104},{"name":170,"role":171,"phone":104,"phoneExt":104,"email":104},"Miguel D'Haeseleer","SUB_INVESTIGATOR",{"name":173,"role":171,"phone":104,"phoneExt":104,"email":104},"Famke Vanderhauweraert",{"name":149,"role":171,"phone":104,"phoneExt":104,"email":104},{"facility":176,"status":154,"city":177,"state":104,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"The Danish MS Hospitals","Ry","8680","Denmark","DK",{"type":160,"coordinates":182},[183,184],9.76505,56.09038,{"lat":184,"lon":183},[187],{"name":188,"role":145,"phone":104,"phoneExt":104,"email":189},"Lars Hvid","LARSHV@sclerosehospital.dk",{"type":191,"investigatorFullName":141,"investigatorTitle":192,"investigatorAffiliation":5,"oldNameTitle":104,"oldOrganization":104},"SPONSOR_INVESTIGATOR","Professor",[194,196,197],{"name":195,"class":6},"Danish MS Hospitals, Haslev and Ry",{"name":5,"class":6},{"name":198,"class":6},"National MS Center Melsbroek","100608487","at-home-use-of-stimulation-suits-for-managing-ms-symptoms-100608487",false,"NCT07202195","At Home Use of Stimulation Suits for Managing MS Symptoms","Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT","HANDS-MS","Inclusion Criteria:\n\n* Eligible participants must have ataxia or spasticity alongside impairments in upper or lower extremity physical function. MAS score ≥ 1 will be used as an inclusion criterion to determine the presence of spasticity. SARA score ≥ 4 will be used as an inclusion criterion to determine the presence of ataxia. Note: one of the two criteria (MAS score or SARA score) must be fulfilled for a pwMS to be eligible.\n* The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately\n* Diagnosis of multiple sclerosis.\n\nExclusion Criteria:\n\n* Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment )\n* Change in disease modifying treatment within the last 3 months\n* Use of Botuline Toxine A within the last 3months\n* Recent relapse within the last 3 months\n* Acute musculoskeletal problems that hinder the test performance,\n* Pregnancy\n* Sizes bigger than 3XL (triple eXtra Large)\n* Skin eruptions and\u002For skin areas in the stimulation zone that are swollen, infected or inflamed.","ALL","18 Years",{"count":210,"type":211},70,"ESTIMATED","INTERVENTIONAL",[214],"NA","This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning.\n\nCan pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?\n\nResearchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).\n\nParticipants in the intervention group will:\n\n* Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home).\n* Receive their usual care in addition to wearing the suit.\n* Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.\n\nParticipants in the control group will:\n\n* Receive their usual care.\n* Undergo clincial tests at the same time points as the other group.",[217,218,219,220,221,222,223,224],"Multiple Sclerosis","MS (Multiple Sclerosis)","Spasticity With Multiple Sclerosis","Ataxia - Other","Ataxia, Cerebellar","Ataxia, Motor","Spasticity","Home Based Care",[226,227,228,229,130,131,230,231,232],"ataxia","spasticity","multiple sclerosis","MS","exopluse molli suit","home-based rehabilitation","symptom management","2026-10-07",{"date":235,"type":236},"2026-10-08","ACTUAL",{"date":238,"type":236},"2026-03-16",{"date":240,"type":211},"2027-09",{"name":141,"class":6},2]