Smart Monitoring Assessing Spasticity-related Health - A Prospective Multiple Sclerosis Study With Wearables
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Wearing time of smartwatch (daily)
研究概览
简要总结
This observational study seeks to investigate the underlying of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring spasticity-related everyday limitations and to compare them with established clinical scores, blood analyses and questionnaires including sores on quality of life, sleep quality or activities of daily living.
详细描述
The symptomatic treatment of spasticity in patients with multiple sclerosis (MS) is a major challenge for both patients and healthcare providers. However, monitoring and measuring the success or failure of treatments in clinical practice remains difficult. This is mainly due to the lack of clinical scores and biomarkers that can be easily and longitudinally collected. Existing scores (such as questionnaires and the Modified Ashworth scale) are rarely used in practice. In addition, the monitoring of side effects (such as dizziness, nausea and fatigue) is difficult in routine clinical practice and often leads to premature discontinuation or switching of treatment. As a result, therapeutic options are often exhausted prematurely. Continuous monitoring with sensitive assessments could enable a better understanding of spasticity treatment.
Approximately 50 patients with moderate and severe spasticity due to MS are to be included in the study. After inclusion, follow-up examinations are carried out every 12 weeks; a total of 3 visits are planned, including the baseline examination.
The study aims to improve the understanding of spasticity symptoms and assess them in patients through multimodal clinical and longitudinal digital measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all the following criteria to be eligible to participate in the study:
- •≥ 18 years of age
- •Diagnosis of multiple sclerosis according to the McDonald criteria of 2017
- •Presence of spasticity that requires medical treatment from a medical point of view
- •own and use a smartphone with Android 8.1 (or higher version) or iOS 12.3 (or higher version)
- •Able to operate a smartphone
排除标准
- •Missing informed consent
- •Lack of declaration of consent
- •Unwillingness or inability to use the smartphone app
- •Any comorbidity that leads to impaired understanding or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be made at the discretion of the investigators.
结局指标
主要结局
Wearing time of smartwatch (daily)
时间窗: 180 days
Longitudinal development of activity parameter: step count
时间窗: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
时间窗: 180 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television
时间窗: 180 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton
时间窗: 180 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles)
时间窗: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
时间窗: 180 days
Longitudinal development of activity parameter: approximate calories burned Time
时间窗: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: number of times user woke up
时间窗: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
时间窗: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points
时间窗: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
时间窗: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
时间窗: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
时间窗: 180 days
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
时间窗: 180 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
时间窗: 180 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
时间窗: 180 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
时间窗: 180 days
The Modified Ashworth Scale (MAS)
时间窗: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Modified Ashworth Scale (MAS) is a clinical tool for assessing muscle spasticity in patients, particularly those with neurological conditions such as multiple sclerosis (MS). It assesses the resistance of a muscle to passive stretching and thus measures the degree of spasticity. The MAS helps to assess the severity of spasticity and monitor the effectiveness of treatment and disease progression. The scale ranges from 0 (no increased muscle tone) to 5 (limbs rigid in flexion and extension).
次要结局
- The Montgomery-Asberg Depression Rating Scale (MADRS)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- The Expanded Disability Status Scale (EDSS)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- Smartwatch Questionnaire(6 months (V3))
- End of Dose Questionnaire (EOD)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- McCorkle and Young Symptom Distress Scale(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- The Multiple Sclerosis Impact Scale 29 (MSIS-29)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- The Numeric Rating Scale (NRS)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- The Edmonton Symptom Assessment Scale (ESAS)(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- Sleep-Questionnaire(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
- EQ-5D-5L(Screening + Baseline (V1), 3 months (V2), 6 months (V3))
研究者
Dr. med. Marc Günter Pawlitzki
Study coordinator / PI
Heinrich-Heine University, Duesseldorf