Neuralplasticity-based Sensory-Rehabilitation Protocol in Post-Stroke Hemiparesis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment, Nottingham Sensory Assessment (Erasmus MC modification of the revised version)
研究概览
简要总结
Primary objectives
1. Todetermine the effectiveness of a neuralplasticity principles based sensoryrehabilitation protocol on motor recovery of the post-stroke hemipareticsubjects2. Todetermine the effectiveness of the protocol on sensory recovery of the subjects
In spite of well-established fact that the recovery ofmotor function following stroke is worsened by somatosensory impairments, verynegligible intervention techniques have been developed and tested for therecovery. Further,there is insufficient evidence for their effectiveness in improving the sensorydeficit and associated motor recovery, functional performance, andparticipation.The major reason for the failure of these sensory interventionswas lack of the neuroplasticity principles in formulation of the program. Thus, a structured and scientifically based programfor enhancing the sensory recovery and associated motor recovery has not beeninvestigated yet.
Sensory deficit is an important, though scarcelyexplored area in Stroke-Rehabilitation. The sensory impairment undoubtedlyaffects the motor paresis which is still a challenge among stroke subjects.This study will lead to development of a novel rehabilitation protocol for themanagement of sensory-motor deficits in stroke. The protocol will not only enhance thesensory recovery but also the motor and functional recovery. The improvedsensation and motor activity will allow the subjects to utilize the pareticupper limb in daily performances. This will reduce the impact of strokedisability and enhance the quality of life. The study, once successful, can be applied for strokerehabilitation in various institutions, centers, and hospitals across the countryimroving the health care for the post-stroke survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Hemiparesis (right or left) (as assessed by Fugl-Meyer assessment62 upper extremity subsection: 0 to 66) First episode of unilateral stroke (as defined by WHO) Ischemic or hemorrhagic stroke 1 to 12 months after the stroke onset Impaired or more sensory deficit of any of the sensory modalities (< 7/8)13 as discerned by Nottingham Sensory Assessment (Erasmus MC modification of the revised version)63 Normal visual abilities (with or without glasses).
排除标准
- •Receptive communication or other language disorder (which could interfere with the assessment and treatment process) Contractures and deformities of hand / finger Use of hand splinting or orthosis Complex regional pain syndrome Severe cognitive or perceptual deficit Concomitant medical illness Cardiovascular instability: resting systolic blood pressure >200mmHg and resting diastolic blood pressure >100 mmHg Pregnancy Renal infection or failure Severe depression (Beck depression inventory > 30) Diabetic or any other neuropathy Skin disorder Peripheral nerve injury of either of the upper limbs.
结局指标
主要结局
Fugl-Meyer Assessment, Nottingham Sensory Assessment (Erasmus MC modification of the revised version)
时间窗: Baseline, 8-week, 12-week
次要结局
- Semmes Weinstein Monofilament, Two-Point Discrimination,3.Modified Rankin scale(Baseline, 8-week, 12-week)