Assessment of the Rehabilitation of Postural Imbalance After Chronic Right Supratensorial Stroke by Prismatic Adaptation: Multicentric Randomised Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)
研究概览
简要总结
Postural imbalance after stroke leads to limitations of activity and a worse autonomy. The postural imbalance is increased in right supratensorial stroke (RSS) compared to left supratensorial stroke. The evidences for the rehabilitation of postural imbalance are weak.
Likewise, disorders of spatial reference frames are increased in RSS. The postural imbalance is correlated with the disorders of spatial reference frames in RSS patients.
Prismatic adaptation (PA) is often used for the rehabilitation of unilateral spatial neglect after RSS. Several studies have demonstrated a peculiar expansion of sensorimotor after-effects to spatial cognition. An immediate effect of reduction in postural imbalance have been showed in acute RSS. Therefore, it is interested to investigate the immediate and delayed effects of PA on the postural balance and the spatial reference frames in chronic RSS to purpose a new therapeutic approach.
The hypothesis of the study is that PA would improve the postural balance (activity) of chronic RSS patients by a reduction in mediolateral postural asymmetry, resulting from a " bottom-up " action of PA on spatial reference frames.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, 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
- 否
入选标准
- •Adult, over 18 years old, and less than 80 years old
- •supratensorial,
- •unilateral,
- •haemorrhagic or ischemic,
- •chronic (over 12 months)
- •Ability to stay over 30 seconds in standing static position with open eyes and close eyes
- •Show a postural imbalance, determined by a body weight bearing on right lower limb ≥ 60% during at least one posturographic evaluation with open eyes and that requires an inpatient rehabilitation
- •Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
- •Free, enlightened and written consent of the patient
排除标准
- •Cerebellar lesion
- •Brainstem lesion
- •Bilateral cerebral lesion
- •All orthopaedic or rheumatologic diseases, retinal visual impairments or other diseases interfering with assessments in accordance with the investigator's judgment
- •Pregnancy or breast feeding
- •Under an administrative or legal supervision
结局指标
主要结局
Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)
时间窗: Change from baseline (mean of the 2 pre-tests) at 7 days after the end of treatment (3 weeks about after the baseline)
Balance : The inter-group difference of within-group changes for the Berg Balance Scale (BBS) Score between 0 and 56 points
次要结局
- Balance: the inter-group difference of within-group changes for the Berg Balance Scale (BBS)(Change from baseline at 1 month after the end of treatment)
- Balance: The inter-group difference of within-group changes for standing static posturographic variables(Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment)
- Lateropulsion: The inter-group difference of within-group changes for the Scale for Contraversive Pushing (SCP)(Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment.)
- The inter-group difference of within-group changes for each spatial reference frame (MSSA, VSSA, OLP, LBA)(Change from baseline at +2 Hours, Day 3, Day 7, Month 1 and Month 3 after the end of treatment)
- Autonomy : Inter-group difference of within-group changes for the Barthel index (BI)(Change from baseline (pre-test) at Day7, Month +1 and Month +3 after the end of treatment.)
- Additionnal descriptive anatomic study of cerebral lesions using diffusion tensor Magnetic Resonance Imaginig (MRI) (Tractography)(Before the starting of the intervention, during the pre-tests.)
- Relationship between prismatic adaptation induced changes on misperceptions of spatial reference frames and these on postural and balance disorders(+2Hours, Day+3, Day+7, Month+1 and Month+3.)