Ataxia, Cerebellar, Ataxia, Motor, Ataxia - Other, Home Based Care, MS (Multiple Sclerosis), Multiple Sclerosis, Spasticity, Spasticity With Multiple Sclerosis
Conditions
Keywords
ataxia, spasticity, multiple sclerosis, MS, neuromodulation suit, stimulation suit, exopluse molli suit, home-based rehabilitation, symptom management
Brief summary
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. Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks? Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit). Participants in the intervention group will: * 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). * Receive their usual care in addition to wearing the suit. * Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation. Participants in the control group will: * Receive their usual care. * Undergo clincial tests at the same time points as the other group.
Interventions
DEVICEelectro-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: * Pulse width: variable between 25 and 170 μs. * Length of period: 50 ms. * 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. The suit comes in different sizes. A trained medical staff pre-programs which nerves/muscles 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.
OTHERUsual Care
The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced/adjusted 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).
Sponsors
Daphne Kos
Danish MS Hospitals, Haslev and Ry
Universitair Ziekenhuis Brussel
National MS Center Melsbroek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately * Diagnosis of multiple sclerosis.
Exclusion criteria
* Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment ) * Change in disease modifying treatment within the last 3 months * Use of Botuline Toxine A within the last 3months * Recent relapse within the last 3 months * Acute musculoskeletal problems that hinder the test performance, * Pregnancy * Sizes bigger than 3XL (triple eXtra Large) * Skin eruptions and/or skin areas in the stimulation zone that are swollen, infected or inflamed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NHPT+SSST score | After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points. | 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. A higher score, indicates a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six spot step test (SSST) | SSST assessment will take place after weeks 1 and 6 of stimulation. | 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. The Maximum value: 300.0 seconds A higher score indicates a worse outcome. |
| Nine Hole Peg Test (NHPT) | NHPT assessment will take place after weeks 1 and 6 of stimulation. | 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). A higher score indicates a worse outcome. |
| Modified Ashworth Scale (MAS) | MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation. | 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). A higher score indicates a worse outcome. |
| Scale for the Assessment and Rating of Ataxia (SARA) | SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation. | 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. The minimum value: 0 The maximum value: 40 A higher score indicates a worse outcome. |
| Numeric Rating Scale (NRS) | NRS assessments will take place after weeks 1 and 6 of stimulation. | 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. |
| 6 Minute walk test | The assessment will take place after weeks 1 and 6 of stimulation. | 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. |
| 5 times sit to stand test (5STS) | The assessment will take place after weeks 1 and 6 of stimulation. | 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. |
| The patient-Determined Disease Steps (PDDS) | PDDS assessment will take place after weeks 1 and 6 of stimulation. | 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. The minimum value: 0 The maximum value: 8 A higher score, indicates a worse outcome. |
| The 12-item Multiple Sclerosis Walking Scale (MSWS12) | MSWS-12 assessment will take place after weeks 1 and 6 of stimulation. | 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. The minimum value: 0 The maximum value: 100 A higher score, indicate a worse outcome. |
| The 36-item Manual Ability Measurement (MAM36) | MAM36 assessment will take place after weeks 1 and 6 of stimulation. | 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. A higher score indicates greater perceived manual ability. |
| The EuroQol Questionnaire (EQ-D5) | EQ-5D assessment will take place after weeks 1 and 6 of stimulation. | The EQ-5D is a standardized instrument that provides a score across five health dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. (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. |
| adapted Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM 1.4) | The adapted TSQM 1.4 assessment will take place after weeks 1 and 6 of stimulation. Only for the intervention group | 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. |
| SymptoMScreen | SymptoMScreen assessment will take place weekly from the start of the intervention until end of the study. | 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/I'm unable to do most daily activities). The minimum value: 0 The maximum value: 72 A higher score indicates a worse outcome. |
| Modified Fatigue Impact Scales (MFIS) | The assessment will take place after weeks 1 and 6 of stimulation. | 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). |
Countries
Belgium, Denmark
Contacts
CONTACTDaphne Kos
CONTACTAlix-Anne Schreinemacher
PRINCIPAL_INVESTIGATORDaphne Kos
Universitair Ziekenhuis Brussel
Outcome results
None listed