The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation
研究概览
简要总结
Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years.
- •Having a clinical diagnosis of stroke for at least three months.
- •Being able to walk freely or with the need of support (modified Rankin score
- •Being a French speaker, able to understand verbal instructions, and affiliated. with the national health insurance (sécurité social).
- •Having spasticity with a score of at least 1+ on the MAS.
- •Having a Berg Balance Scale score ≤46 associated across the literature with a risk of fall.
排除标准
- •Being included in another research protocol during the study period.
- •Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
- •Having contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
- •Being pregnant (confirmed by a blood beta-HCG test).
- •Having a change in their pharmacological therapy in the last three months.
- •Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
- •Having a body mass index above 35 Kg/m
- •In case of introducing a medical device other than EXOPULSE Mollii suit during the study period.
- •Patients under juridical protection (" mesure de protection) judiciare : tutelle, curatelle, sauvegarde de justice ")
- •Patients deprived of freedom (" personnes privées de liberté ".)
研究组 & 干预措施
Experimental Condition
Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted.
EXOPULSE Mollii Suit is used for activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax.
干预措施: EXOPULSE MOLLII SUIT (active) (Device)
Control Condition
In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour).
干预措施: EXOPULSE MOLLII SUIT (sham) (Device)
结局指标
主要结局
Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation
时间窗: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)
Balance will be assessed using the 14-item BBS which has good psychometric properties in patients with stroke. The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.
次要结局
- Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale)(Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit)
- Assessment of the spasticity using the MAS (Modified Ashworth Scale) and the VAS pain (Visual Analogue Scale)(This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6))
- Mobility will be assessed using the TUG scale (Time Up and Go)(This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6))
- Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)(Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2))
- Evaluation of overall improvement using the CGI (Clinical Global Impression)(This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions)
- Quality of life will be measured using the EQ-5D-5L (EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire)(Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2))
- Pain and fatigue will be assessed using a VAS (Visual Analogue Scale)(This will be assessed through study completion, an average of 3 months (at Visit 1, V2, V3, V4, V5 and V6))
- Evaluation of patient's blinding to the type of stimulation in the crossover trial(This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) since it's designed to be applied after interventions of phase 1 (double blind phase))