Reliability, Validity and Clinical Utility of a Robotic Assessment of Finger Proprioception in Neurological Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Error
研究概览
简要总结
The aim of this case-controlled observational cross-sectional study is to investigate the test-retest reliability, validity and clinical utility of a rapid robotic assessment of finger proprioception using a passive gauge position matching tasks in MS and stroke subjects.
Session 1 Informed consent Descriptive measures Session 2 Clinical testing Robotic assessment (3x) Session 3 Clinical testing Robotic assessment (3x)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Inclusion criteria MS subjects
- •Age > 18 years
- •Diagnosis of MS (McDonald criteria)
- •No relapse or relapse-related treatment within the last 3 months prior to the study
- •Inclusion criteria Stroke subjects
- •Age > 18 years
- •Diagnosis of stroke (ischemic or hemorrhagic),
- •Between 2 weeks and 12 months post-stroke
排除标准
- •Complete paralysis of both upper limbs
- •Unable to detect any passive movement in hand and fingers
- •Unable to place the hand in the robotic devices without any discomfort or pain
- •Marked or severe intention tremor (Fahn's tremor rating scale on finger-to-nose test > 3)
- •Marked or severe spasticity for finger and elbow flexors or shoulder adductors (Modified Asworth scale >3)
- •Other medical conditions interfering with the hand function (peripheral nerve lesion, orthopedic or rheumatoid impairment, pain, edema)
- •Severe cognitive or visual deficits interfering with testing and training (e.g. Aphasia, neglect, ...)
研究组 & 干预措施
persons with Multiple Sclerosis (MS)
25 persons with MS Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.
干预措施: Robotic assessment of finger proprioception (Other)
stroke patients
25 stroke patients Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.
干预措施: Robotic assessment of finger proprioception (Other)
healthy controls
50 healthy controls Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.
干预措施: Robotic assessment of finger proprioception (Other)
结局指标
主要结局
Error
时间窗: day 3
The extracted parameter is measured by the robotic device. The MCP angular position measured by the robot and the angle reported on the touchscreen by the subject.
次要结局
- sex(day 1)
- Age(day 1)
- medication use(day 1)
- the modified Ashworth scale(day 1)
- Edinburgh Handedness Inventory(day 1)
- Nine Hole Peg test(day 1)
- Box and block test(day 1)
- Manual Ability Measure-36 (questionnaire)(day 1)
- Symbol digit modalities test(day 1)
- 25 foot walk test(day 1)
- Semmens-Weinstein monofilaments(day 3)
- Rydel Seiffer Tuning fork(day 3)
- The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)(day 3)
- The System Usability Scale (SUS)(day 3)
研究者
Peter Feys
Principal Investigator
Hasselt University