Comparative Effects of Sensory Augmentation and Neuromodulation on Enhancing Motor Recovery Among Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Jebsen-Taylor Test
研究概览
简要总结
This study aims to evaluate the effectiveness of two rehabilitation techniques-Sensory Augmentation (using mirror therapy) and Neuromodulation (using transcranial direct current stimulation, tDCS)-in improving motor recovery among stroke survivors. Stroke often results in long-term impairments, particularly in upper limb motor function, which is critical for daily activities. Although current rehabilitation strategies help, more effective solutions are needed to enhance recovery. Participants, aged 45-65 with chronic stroke and upper extremity impairments, will be randomized into three groups: Group 1 will receive a combination of sensory augmentation (mirror therapy) and neuromodulation (tDCS) with routine physical therapy; Group 2 will receive sensory augmentation (mirror therapy) with routine physical therapy; and Group 3 will receive neuromodulation (tDCS) with routine physical therapy. The interventions will take place four times a week for 8 weeks, and participants will undergo motor function assessments, including the Fugl-Meyer Assessment and Jebsen-Taylor Test, before and after the intervention. The study will compare the effects of each intervention on motor recovery, specifically focusing on upper limb function and motor control. The findings could lead to improved rehabilitation protocols, offering stroke survivors better therapeutic options and enhancing their quality of life.
详细描述
Stroke is one of the leading causes of disability worldwide, often leading to long-term impairments in motor function, particularly in the upper limbs. These impairments can severely affect a person's ability to perform daily tasks, reducing their independence and quality of life. The rehabilitation process for stroke survivors typically includes physical therapy aimed at improving motor control, balance, and functionality of the affected limbs. While traditional rehabilitation strategies are effective, there is a growing interest in enhancing recovery through advanced techniques such as Sensory Augmentation and Neuromodulation.
This study will focus on evaluating the comparative effects of two innovative rehabilitation approaches-Sensory Augmentation through Mirror Therapy and Neuromodulation through Transcranial Direct Current Stimulation (tDCS)-on motor recovery in chronic stroke survivors. These two techniques have shown promising results in improving motor function in stroke patients, but their combined effect remains unclear.
Intervention Strategies:
Sensory Augmentation: Mirror therapy is a non-invasive technique that involves using a mirror to create the illusion of movement in the affected limb by reflecting the movement of the unaffected limb. This process enhances the sensory feedback and promotes neuroplasticity, which is the brain's ability to reorganize and form new neural connections. Mirror therapy has been shown to reduce spasticity, improve sensory functions like proprioception, and facilitate the restoration of motor function.
Neuromodulation: Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation technique that uses a low electrical current to modulate neuronal activity in specific areas of the brain. For stroke survivors, tDCS is applied to the motor cortex to promote neuroplasticity, facilitate the relearning of motor tasks, and reduce spasticity. While previous studies have demonstrated the effectiveness of tDCS, its impact when combined with sensory augmentation has not been fully explored.
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 (Participant)
盲法说明
This study will use a single-blind design, where the participants will be unaware of the specific intervention group they have been assigned to (i.e., whether they are receiving the combination of sensory augmentation and neuromodulation, sensory augmentation alone, or neuromodulation alone). This masking ensures that participant expectations do not influence their responses to the interventions. However, the treating therapists and study coordinators who administer the interventions and assess outcomes will not be masked, as they will be responsible for the direct management of the interventions and data collection. This design allows for an objective evaluation of the effects of the interventions while minimizing potential biases from participant expectations.
入排标准
- 年龄范围
- 45 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 45-65
- •Gender: both male and female
- •Ischemic stroke
- •Diagnosed cases of middle cerebral artery stroke by neurologist
- •Stage of recovery - Chronic (more than 6 months)
- •Burnstromm recovery stage 3
- •Good Compliance
排除标准
- •Vestibular Dysfunction
- •Serious cognitive impairment,
- •Severe vision or visuospatial neglect
- •Spasticity (Modified Ashworth scale >3)
- •Upper extremity contractures
- •Upper extremity fractures
- •Orthopedic disease
- •Neurological conditions (other than stroke)
- •Recurrence of stroke or epilepsy during the study period
- •Serious systemic impairment or concomitant diseases
- •Patients refused to participate in the experiment
结局指标
主要结局
Jebsen-Taylor Test
时间窗: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
The Jebsen-Taylor Test of Hand Function (JTT) is a standardized assessment used to evaluate the functional use of the hands in everyday tasks, particularly for stroke patients. It includes seven subtests: writing, card turning, picking up small objects, simulated feeding, stacking checkers, and moving light and heavy objects. These tasks simulate common daily activities that require hand function. The JTT is scored based on the time it takes to complete each task, with shorter times indicating better hand function. The total score is the sum of the times for all subtests. Interpretation: Lower total times suggest better hand function, while longer times indicate greater motor impairment. The test helps assess the ability to perform functional tasks, providing a realistic measure of hand performance and recovery. It's valuable for evaluating improvements in motor function following rehabilitation interventions.
Fugl-Meyer Assessment Scale
时间窗: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
The Fugl-Meyer Assessment (FMA) is a comprehensive, standardized tool used to assess motor function recovery in stroke patients, focusing on the upper limb, balance, and sensory function. The FMA includes subscales for motor function, sensory function, balance, and joint range of motion. The motor function subscale, which is particularly relevant in this study, evaluates voluntary movements, reflexes, coordination, and muscle strength of the upper limbs. The FMA scale ranges from 0 to 66 for the upper limb, with higher scores indicating better motor function. A score of 66 represents full motor recovery, while 0 indicates no motor function. Intermediate scores reflect varying levels of impairment and recovery. The FMA is widely used for its sensitivity in detecting changes over time, making it an effective tool for tracking motor recovery after stroke.
Jebsen-Taylor Test
时间窗: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
The Jebsen-Taylor Test of Hand Function (JTT) is a standardized assessment used to evaluate the functional use of the hands in everyday tasks, particularly for stroke patients. It includes seven subtests: writing, card turning, picking up small objects, simulated feeding, stacking checkers, and moving light and heavy objects. These tasks simulate common daily activities that require hand function. The JTT is scored based on the time it takes to complete each task, with shorter times indicating better hand function. The total score is the sum of the times for all subtests. Interpretation: Lower total times suggest better hand function, while longer times indicate greater motor impairment. The test helps assess the ability to perform functional tasks, providing a realistic measure of hand performance and recovery. It's valuable for evaluating improvements in motor function following rehabilitation interventions.
次要结局
未报告次要终点