Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Number of correct movements
研究概览
简要总结
The objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. For that purpose the investigators use the SWORD system that combines 3D motion quantification wearable sensors and a vibratory module.
The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time.
The design of the study is a cross-over randomized clinical trial. With the SWORD system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. The number of correct movements and other motor outcomes will be assessed continuously under both conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •More than 18 years old at stroke onset, with no superior age limit;
- •Medical diagnosis of acute ischemic stroke;
- •First ever stroke;
- •Previously independent, defined as having a modified Rankin scale (mRS) of 0-1;
- •Clinical and CT or MRI compatible with a medial cerebral artery ischemic lesion;
- •Confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits >10°), defined as a score between 0 and 2 on items 5a or 5b of the National Institute of Health Stroke Scale;
- •Inpatients, within no more than 4 weeks after stroke onset;
- •Medically stable, no intravenous medication and already able to sit for more than one hour comfortably;
- •Favourable opinion of the attending stroke physician;
- •Patient and caregiver understand the purpose of the study and provided written informed consent.
排除标准
- •No detectable motor deficits at baseline assessment by the neurologist;
- •Severe aphasia;
- •Dementia (any stage);
- •Other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks;
- •Severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position;
- •Pain that limits upper limb movement either on the normal or affected side;
- •Upper limb amputation or severe deformity either on the normal or affected side;
- •Fixed articular limitations of upper limb either on the normal or affected side;
- •Enrollment in other trial in the previous 3 months.
结局指标
主要结局
Number of correct movements
时间窗: At the end of each hand-to-mouth task.
Number of correct movements performed within the duration of each hand-to-mouth task.
次要结局
- Time between correct movements in seconds(At the end of each hand-to-mouth task.)
- Cumulative amplitude of correct movements in degrees(At the end of each hand-to-mouth task)
- Number of pause events during the task(At the end of each hand-to-mouth task)
- Total number of movements(At the end of each hand-to-mouth task.)
- Range of motion in degrees(At the end of each hand-to-mouth task.)
- Cumulative amplitude of all movements performed in degrees(At the end of each hand-to-mouth task.)
- Fatigue(At the end of each hand-to-mouth task.)
- Pain(At the end of each hand-to-mouth task.)
- Number and type of other distresses(At the end of each hand-to-mouth task.)
研究者
Vítor Tedim Cruz
MD
Centro Hospitalar de Entre o Douro e Vouga