Effectiveness of Robotic-based ACTive somatoSENSory (Act.Sens) Retraining on Upper Limb Functions: Protocol for a Pilot Randomised Controlled Trial With Community-dwelling Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in motor behavioral scores
研究概览
简要总结
The current work aims to examine whether the proposed rehabilitation training or exercise will eventually yield improvements in both motor and somatosensory aspects at one goal. Here, the word 'somatosensory' refers to bodily sensations associated with proprioception or kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper limb retraining for community-dwelling stroke survivors using a robotic device. At the end of training, both movement accuracy and somatosensory acuity in chronic stroke survivors are presumed to improve, and such paradigm is expected to provide reliable benefits as compared to conventional intervention alone.
详细描述
Long-term disability is common sequela among people with stroke. On top of motor impairment, many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to their inability to perform activities of daily living using upper limb. In this respect, recent research on motor recovery following stroke has begun to place more emphasis on the inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is still scarce, training paradigms that simultaneously combine both somatosensory and motor aspects are considered useful for motor recovery in stroke survivors. Principally, studies focusing on such form of training paradigm sought to employ robotic technologies to assist in the retraining of both motor and somatosensory function in stroke survivors. Robotic technologies have gained popularity recently for assessing somatosensory function in clinical setting due to its objective quantification of patients' performance and high inter-rater reliability. Thus, with the purpose of improving both motor and somatosensory functions in chronic stroke survivors, this proposed study will provide an intensive robotic-based behavioral training intervention to chronic stroke survivors from the community. The intervention will require active participation of the patients through an exploratory strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-time ischemic or haemorrhagic stroke survivors;
- •Patients of at least 6-month post-stroke;
- •Patients with severe to moderate sensory impairment as assessed by Erasmus Nottingham Sensory Assessment (≤ 6/8);
- •Patients with arm motor impairment, shoulder abduction and elbow extension Medical Research Council (MRC) motor power grade 3-5;
排除标准
- •Patients with bilateral impairment;
- •Patients with high upper-limb spasticity (Ashworth scale > 2);
- •Patients with unilateral neglect as assessed by Star Cancellation Test (score < 44);
- •Patients with cognitive impairment as assessed by a 2-step instructions from the modified Mini Mental State Examination;
- •Patients with a known history of mental disorders;
- •Patients with the inability to perform upper arm activity due to excessive pain
结局指标
主要结局
Change in motor behavioral scores
时间窗: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
A robotic-based assessment to evaluate the movement accuracy of patients' paretic arm. This will be analyzed through their ability to propel the robotic handle to a target location as straight and as fast as possible. Key kinematic parameters such as endpoint deviation (cm) and movement smoothness will be computed where larger numbers indicate worse performance.
Change in somatosensory acuity
时间窗: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
A robotic-based assessment to measure performance in proprioception/kinesthesia of patients' paretic arm. This will be analysed through their ability to first passively sense where the arm is being moved to and later on to reproduce the movement made by the robot. Key kinematic parameters such as endpoint deviation (cm) will be computed where a larger number indicate worse performance.
次要结局
- Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)(Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).)
- Change in streamlined Wolf Motor Function Test (WMFT)(Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).)
- Change in Erasmus-MC version of the Nottingham Sensory Assessment (EmNSA)(Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).)
研究者
Ananda Sidarta
Research Fellow
Nanyang Technological University