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临床试验/NCT01677091
NCT01677091已完成不适用

Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.

Rennes University Hospital14 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
14
主要终点
The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention.

研究概览

简要总结

The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.

详细描述

Imbalance is particularly severe after a Cerebral Vascular Accident because they not only limit the capacity of transfer and are a source of falls but also represent an obstacle to the acquisition of autonomy.

When the brain lesion is located in the right hemisphere, the prognosis in terms of equilibrium is worse probably because of the presence of disorders of spatial cognition. These disorders of spatial cognition are manifested by a distortion of the mental representation of space and body in space that probably cause a deviation of the position of the center of pression on platform. This component of balance disorders secondary to disruption of spatial cognition, do not benefit at present from specific rehabilitative treatment despite the severity of the consequences.

But the application of sensory manipulations has proven its effectiveness on visuospatial neglect that is another disorder of spatial cognition closed to the pathophysiology of balance disorders after right brain lesion. Sensory manipulations decrease the distortion of internal representations of the body in space by restoring the symmetry of sensory inputs. Some of these manipulations (visual manipulation by wearing prisms and proprioceptive manipulations) are also effective on the immediate correction of postural imbalances on force platform and disorders of spatial perception.

We therefore believe that the approach by repeated sensory manipulation is a new promising way of research for the rehabilitative treatment of balance disorders secondary to disorders of spatial cognition. As the mechanisms of action and the structures involved during proprioceptive vibration of neck muscles and during visual prism adaptation are different, we believe that the combination of these two types of sensory manipulations will permit to obtain a greater and longer lasting effect than a lonely manipulation. The concomitant evaluation of the bias on postural platform and the perception of the body axis will allow us to assess the impact of such rehabilitation on the disorders of spatial representation and so better understand the mechanisms of action of sensory manipulations.

The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration (V) and / or prism adaptation (P) in patients with left hemiplegia on balance at the end of the intervention (day14).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right unilateral supratentorial ischemic or hemorrhagic lesion
  • Adult (age ≥ 18 years) under 80 years
  • older than 9 months
  • with or without hemianopsia
  • with or without visuospatial hemineglect
  • The first symptomatic episode
  • Standing balance ≥ 30 sec unaided
  • Percentage of weight rests on the hemiplegic lower limb below 40% of body weight (on a platform of strength)
  • Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)

排除标准

  • Orthopedic, rheumatologic or visual disorders affecting the distribution of the center of pressure while standing
  • Visual disorder that does not allow assessment of the longitudinal axis or visual straight ahead
  • Ischemic or hemorrhagic brain stem lesion
  • Trouble for understanding protocol procedures
  • Inclusion Criteria for the healthy volunteers (ancillary study) :
  • Age ≥ 18 years, right-handed, sex and age-matched (+/- 5 years) to the patients of the coordinating center
  • Able to get an MRI
  • With no imbalance
  • With no visual disorder impacting the repartition of the center of pression when standing up, or that does not allow assessment of the longitudinal axis or visual straight ahead
  • Written informed consent

结局指标

主要结局

The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention.

时间窗: Day 14

次要结局

  • Evaluation of balance(Day 0, Day 14, Month 3, Month 6)
  • Evaluation of functional capacity(Day 0, Day 14, Month 3, Month 6)
  • Evaluation of negligence(Day 0, Day 14, Month 3, Month 6)
  • Understanding the mechanisms of sensory manipulations(Day 0, Day 14, Month 3, Month 6)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (14)

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