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临床试验/NCT03369470
NCT03369470已完成不适用

A New App Home Based Dexterity Training in Multiple Sclerosis: a Randomized Controlled Trial

Luzerner Kantonsspital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ)

研究概览

简要总结

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common cause of non-traumatic disability in young adults (Kamm et al. 2014; Vanbellingen & Kamm, 2016). It is a heterogeneous disease, which is associated with long-term disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological therapies (DMT) decrease activity and progression of the disease, and symptomatic pharmacological treatments reduce complaints to a certain extent, however MS patients often still suffer from various neurological deficits during the course of their disease (Kamm et al. 2014). Consequently, specific non-pharmacological therapies are needed in order to further reduce disability, eventually resulting in better QoL (Lamers et al. 2016; Vanbellingen & Kamm, 2016).

Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia, spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience impairments in the performance of several activities of daily living (ADL), such as grooming, cooking, etc. Sometimes these problems are even associated with loss of work, and lack of social integration (Chruzander et al. 2013).

The effectiveness of the app based exercises still needs to be proven. With respect to dexterity, a first new app has been developed called "Finger Zirkus", by a team of experts including an occupational therapist, graphic designer, and IT expert. The app is already available to be downloaded from google play store or apple store (see for more details: www.fingers-in-motion.de).

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)

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

  • •The inclusion criteria for MS patients are as follows: males and females, age 18 to 75, diagnosis of MS (primary or secondary progressive, relapsing-remitting) following the McDonald criteria (Polman et al. 2011). In addition, patients must report difficulties in manual dexterity that impact ADL and/or have a pathological nine Hole Peg Test (9HPT) or Coin Rotation test (CRT) according to cut-off values (Mathiowetz et al. 1985; Heldner, Vanbellingen et al. 2014).

排除标准

  • •The exclusion criteria will be other conditions that may hand function or, impaired cognitive functioning (Mini Mental Status Examination score less than 24).

研究组 & 干预措施

App Dexterity

Experimental

干预措施: App Dexterity (Behavioral)

Theraband

Active Comparator

干预措施: Theraband (Behavioral)

结局指标

主要结局

AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ)

时间窗: 4 weeks

AMSQ is a patient recorded outcome measurement for manual dexterity in MS patients (Mokkink et al. 2015). The "Arm Function in Multiple Sclerosis Questionnaire" (AMSQ) measures manual dexterity in patients with MS. It contains 31 questions on a unidimensional scale that are formulated as 'during the past two weeks, to what extent has MS limited your ability to ......?'. Response categories are from one to six ('not at all', 'a little', 'moderately', 'quite a lot', 'extremely', and 'no longer able to'). One final sum score is obtained with higher scores indicating more dexterous difficulties.The Dutch version showed good validity, test-retest reliability (ICC 0.90; SEM 5.6) and inter-observer reliability (ICC 0.95; SEM 7.2)

次要结局

  • Nine Hole Peg Test (9HPT)(4 weeks)
  • Multiple Sclerosis Impact Scale 29 (MSIS 29)(4 weeks)
  • Coin Rotation Task (Kamm et al. 2012)(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tim Vanbellingen

Head of department

Luzerner Kantonsspital

研究点 (1)

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