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临床试验/NCT03668990
NCT03668990已完成不适用

Feasibility, Validity and Reliability Kinematic Movement Analysis of Upper Limb Movements in Stroke and MS Patients Using Inertial Sensors

Hasselt University4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年10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
发起方
入组人数
18
试验地点
4
主要终点
kinematic parameter

研究概览

简要总结

This study has 3 aimes:

  1. To investigate the feasibility of using IMUs (Xsens, MVN Studio) during functional tasks to assess upper limb kinematics in pwMS and stroke survivors. On the one hand, the feasibility of performing the tasks will be investigated . On the other hand, does the XSens give valuable data?
  2. To investigate the discriminative validity of kinematic measurements of upper limb movements post-stroke and pwMS in comparison with gender and age-matched healthy controls
  3. To investigate the test-retest reliability of the kinematic parameters collected during the different functional tasks in pwMS and stroke survivors

It is a cross-sectional case-controlled observational study, with 3 different groups: 25 Persons with Multiple sclerosis, 25 stroke patients and 50 healthy controls, matched by age and gender.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • Inclusion criteria for all participants: Healthy controls, pwsMS and stroke patients
  • No orthopedic or neuro-muscular impairments in the upper limb
  • Age > 18 years
  • Able to understand and execute the test instructions
  • Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)
  • Able to move a joint (wrist, elbow or shoulder) in the upper limb against gravity without resistance (Medical Research Council) (16).
  • Inclusion criteria for PwMS:
  • Diagnosed with MS using McDonald criteria (17)
  • Inclusion criteria Stroke patients
  • First- ever single, unilateral (ischemic or hemorrhagic)
  • At least one month after stroke
  • No apraxia or hemi spatial neglect

排除标准

  • Exclusion Criteria for pwMS only:
  • a relapse 3 months before the start of the study
  • A change of symptomatic medication during the testing period
  • Exclusion Criteria:
  • People with predominantly ataxia or tremor are excluded from the reliability part of this study

研究组 & 干预措施

persons with Multiple Sclerosis (MS)

Other

25 persons with MS Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements.

Funcitonal-oriented upper limb movements are performed at two different test days.

干预措施: IMUs (Xsens, MVN Studio) (Other)

stroke patients

Other

25 stroke patients Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements.

Funcitonal-oriented upper limb movements are performed at two different test days.

干预措施: IMUs (Xsens, MVN Studio) (Other)

Healthy controls

Other

50 healthy controls Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements.

Funcitonal-oriented upper limb movements are performed at two different test days.

干预措施: IMUs (Xsens, MVN Studio) (Other)

结局指标

主要结局

kinematic parameter

时间窗: day 3

The data received of the IMU's are the angles of point task achievement (PTA). PTA is defined as the instant when the ROM, needed for successful task execution, was achieved. Different joint angles of PTA will be calculated by MVN BIOMECH software. Matlab (software version R2016b) and excel will be used to process the data.

次要结局

  • Action Research arm test(Day 1)
  • Trunk Impairment Scale(day 1)
  • The Brunnström Fugl Meyer (BFM)(day 1)
  • Manual Ability Measure-36 (questionnaire)(day1)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Feys

Principal Investigator

Hasselt University

研究点 (4)

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