跳至主要内容
临床试验/NCT02860403
NCT02860403已完成不适用

Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年2月最近更新:
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
16
试验地点
2
主要终点
Motor imagery ability

研究概览

简要总结

Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-55 years old,
  • quadriplegia elicited by spinal cord injury (SCI) at the C5, C5-C6, C6, or C6-C7 level,
  • complete infra-lesional motor deficit according to the ASIA impairment scale with finger and forearm flexor muscles paralysis,
  • post-traumatic period >6 months (since a motor recovery plateau is usually reached at 6-month post-SCI

排除标准

  • non-stabilized hypertension or pathological autonomic nervous system dysfunction (e.g., orthostatic hypotension),
  • cerebral damage and/or cognitive deficit,
  • elbow or shoulder joint amplitude restriction, upper limb para-osteoarthropathy,
  • participation to another study
  • presence of metallic objects within the body incompatible with MEG or functional magnetic resonance imaging (fMRI) recordings.

研究组 & 干预措施

C6-C7 patients

Experimental

C6-C7 patients able to recover tenodesis grasp.

干预措施: motor imagery (Procedure)

C5-C6 patients

Experimental

C5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation

干预措施: motor imagery (Procedure)

Control group

No Intervention

a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder

结局指标

主要结局

Motor imagery ability

时间窗: 10 weeks

Motor imagery ability assessed by magnetoencephalography measurements

次要结局

  • time to maximal opening(10 weeks)
  • Trajectory of movement measured in the XY plane(10 weeks)
  • joint amplitude evaluated in degrees (°) by the physiotherapist(10 weeks)
  • muscular force evaluated by muscle testing performed by a physiotherapist(10 weeks)
  • Box and Block test(10 weeks)
  • amplitude of electrodermal responses(10 weeks)
  • absolute time to peak velocity(10 weeks)
  • duration of electrodermal responses(10 weeks)
  • Movement time (MT)(10 weeks)
  • movement amplitude at peak velocity(10 weeks)
  • time to opening(10 weeks)
  • height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane(10 weeks)
  • Kinesthetic and Visual Imagery Questionnaire(10 weeks)
  • amplitude of maximal opening(10 weeks)
  • Minnesota test.(10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验