Home-based Virtual Reality (VR) Headset-based Dexterity Training in Multiple Sclerosis: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Arm Function Score in Multiple Sclerosis Questionnaire
研究概览
简要总结
The aim of the study is to investigate if a specifically developed home-based dexterity training intervention using a Virtual Reality (VR) Headset (Meta quest 2) improves impaired manual dexterity in persons with multiple sclerosis.
详细描述
Subjects will be recruited during regular visits at the MS centre of the Luzerner Kantonsspital, Switzerland or at the Department of Neurology of the University Hospital Basel. Ethical approval will be obtained, and the trial will be registered in the clinicaltrials.gov database. Patients must sign informed consent prior to study entry (=Screening). If patients are eligible at screening as defined in the Inclusion- and Exclusion criteria, all primary and secondary outcome measurements will be performed at Baseline. Subjects will be randomized 1:1 in Group 1 (Training intervention) or Group 2 (Sham-Intervention) and instructed into the respective training. After 4 weeks of training, all primary and secondary outcome measurements will be repeated, and the study ends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Raters will not be involved in the screening and randomisation process and blinded with regard to the treatment group
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
- •MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria (Thompson et al. 2017)
- •Age between 18 and 75 years
- •Written informed consent signed by the subject must be obtained prior to study start
- •Patient must complain about MS related impaired manual dexterity negatively affecting ADL and/or QoL
- •Patients must have Arm function in multiple sclerosis questionnaire (AMSQ) score >41
排除标准
- •A relapse that started within 60 days prior to screening
- •Rapidly progressive disease
- •Any disease/condition that impaired manual dexterity besides MS
- •Any disease other than MS that could possibly explain the patient's signs and symptoms
- •Medical or psychiatric conditions that compromise the ability to comply with the protocol, or to complete the study
- •History of epilepsy or epileptic seizures
- •A history of drug abuse in the 12 months prior to screening
研究组 & 干预措施
Experimental intervention = training intervention (Group1)
Eight training programs will be performed addressing different key movements of the hand/arm. All training programs will be performed in sitting position. Training will be performed for 4 weeks, 5 days/week. All 8 training programs will be performed on every training day which corresponds to approximately 20min training/day.
干预措施: VR-based dexterity training in MS (Device)
Control inervention = Sham-Intervention (Group2)
The Sham-Intervention will be the commercially available meditations App "Tripp®". During a period of four weeks, patients will perform the Sham intervention 3 times a week, each session being approximately 20 minutes.
干预措施: mediation program (Other)
结局指标
主要结局
Arm Function Score in Multiple Sclerosis Questionnaire
时间窗: 4 weeks
The Arm Function in Multiple Sclerosis Questionnaire (AMSQ) measures manual dexterity in patients with MS. It contains 31 questions on a unidimensional scale. One final sum score is obtained with higher scores indicating more dexterous difficulties. The minimum score is 31 (no limitation) and a maximum score of 186 (extreme limitation).
次要结局
- Scores of the Electronic Neurostatus-Expanded Disability Status Scale (eEDSS) (D'Souza M et al. 2020)(4 Weeks)
- Time for completing the Nine-hole-Peg-Test (9HPT)(4 weeks)
- Time for completion the Coin rotation task (CRT)(4 Weeks)
- The highest strength value resulting from the Handheld JAMAR dynamometer(4 Weeks)
- Value resulting from the Multiple Sclerosis Impact Scale 29 (MSIS 29)(4 Weeks)
研究者
Christian Kamm
Prof. Dr. med.
Luzerner Kantonsspital