Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.
详细描述
Optimization Aim: Identify a systematic, methodological approach to device fitting, in-clinic and at-home protocols using the Mollii suit, and optimization of collecting outcome measures at assessment visits. For example, up to 15 participants will complete a portion or all of the procedures listed in the "Procedures Involved" section of this protocol to determine an optimal approach.
Aim 1: Assess the safety of the Mollii suit during an in-clinic or at-home up to 12-week period consisting of up to daily sessions of a 60-minute duration in individuals with pain and/or spasticity from neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.
Aim 2: Evaluate the use of full-body active electrostimulation as compared to full-body sham electrostimulation as an intervention in-clinic or at-home for individuals experiencing pain and/or spasticity due to neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.
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
- Single (Participant)
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 18 to 75 years old
- •Medical clearance from physician
- •Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia
- •For participants with a diagnosis of Multiple Sclerosis:
- •having a definite diagnosis for at least one month
- •Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) < 7).
- •Absence of relapses in the last three months
- •Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)
- •Berg Balance Scale (BBS) score of ≤ 46 (associated in the literature with a risk of fall)
- •For participants with a diagnosis of Fibromyalgia:
- •a. having a definite diagnosis for at least three months
- •Able to follow instructions and inform study staff of pain and/or discomfort
- •Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance
排除标准
- •Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
- •Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used
- •No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
- •Pregnant and/or nursing
研究组 & 干预措施
Intervention
Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running.
干预措施: Active full-body stimulation (Device)
Sham
Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running.
干预措施: Sham full-body stimulation (Other)
结局指标
主要结局
Berg Balance Scale
时间窗: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks
The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance.
次要结局
- Manual Muscle Test(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- Modified Ashworth Scale(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- 10 Meter Walk Test(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- 6 Minute Walk Test(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- Timed Up and Go(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- Twelve-Item Multiple Sclerosis Walking Scale(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- Falls Efficacy Scale(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- Multiple Sclerosis International Quality of Life Questionnaire(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
- Clinical Global Impressions Scale(Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks)
研究者
Arun Jayaraman, PT, PhD
Director - Max Nader Center for Rehabilitation Technologies and Outcomes Research
Shirley Ryan AbilityLab