Combined Effects of Auditory and Visual Rhythmical Cueing on Lower Limb Sensorimotor Recovery and Gait Parameters in Patients With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Stride length
研究概览
简要总结
Stroke is also known as a brain attack, happens when a blood vessel in the brain breaks or when something stops the flow of blood to a specific area of the brain. Parts of the brain undergo damage or die in either case. Stroke victims may experience permanent brain damage, long-term disability or even death. The main objective of this study is to evaluate the impact of combined auditory and visual rhythmical cueing on lower limb sensorimotor recovery and gait parameters in patients with hemiplegia. It will be a randomized controlled trial. In this study 28 patients will be recruited through non probability convenience sampling technique. The patients fulfilling inclusion and exclusion criteria will be randomly divided into experimental group (n=14) and control group (n=14) by using computer engendered in blocks by using a basic number generator. Distribution will be concealed by the sealed envelope method. Baseline treatment will be given to both groups.
Baseline treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Conventional training will be given for 15 minutes, 3 sessions per week for 4 weeks. Experimental group (n=14) will be treated with auditory stimulation and visual cues. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks. The control group (n=14) will be treated with auditory stimulation only. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks.
Subjective tool for sensory assessment includes Fugl-Meyer Assessment (FMA) for the lower extremity (LE) tool. For gait, it includes Dynamic Gait Index (DGI) tool. Objective tools will include cadence, gait velocity/walking speed, stride length, step length, step width, stride length symmetry ratio and step length symmetry ratio. Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.
详细描述
A neurological condition known as a stroke is characterized by blood vessel obstruction. Brain clots prevent blood from flowing properly, obstructing arteries and causing blood vessels to burst, which causes bleeding. The abrupt death of brain cells due to a lack of oxygen occurs when the arteries leading to the brain are ruptured during a stroke . Stroke subtypes can be categorized as ischemic or hemorrhagic depending on the etiology. The majority of stroke cases (80-87%) are ischemic strokes, which can be either focal (caused by thrombosis, cardio-embolism, or atherosclerosis and platelets plugging an artery) or global (caused by a complete reduction in blood flow to the brain during a cardiac arrest). Ischemic stroke can also be lethal or not. On the other side, a blood vessel rupture results in hemorrhagic stroke . During a transient ischemic attack (TIA), arterial supply to brain tissue is temporarily cut off, resulting in focal neurologic symptoms such as hemiparesis, but spontaneous flow restoration leads to symptom relief without long-term tissue damage . Gehan M. Ahmed1, Ebtesam M. Fahmy (2023) did an RCT (randomized control trial) study in which they recruited 30 male stroke patients. Group A (control group) was treated with strengthening exercises for weak upper and lower limb, stretching exercises for lower extremity muscles, weight bearing on affected side and treadmill exercises for 6 weeks. While group B (experimental group) had rhythmical auditory stimulation (RAS) in addition with treadmill training exercise. Results of this study showed that post treatment improvement in gait parameters was significantly higher in the study group compared to the controls.
Xin Li1, Lu Wang (2022) did a controlled study in which they enrolled 24 stroke patients with severe upper limb motor deficits. One group (n=12) was treated with combined conventional training and sensorimotor rhythm-based brain computer interference (SMR-BCI) with an audio cue, motor observation with multisensory feedback for rehabilitation of upper limb. The second group(n=12) was treated with conventional treatment only. Results of this study concluded that the first group which was treated with combined conventional and (SMR-BCI) with auditory cues, motor observation with sensory feedback might promote long lasting upper limb improvement.
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 (Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range between 45-65 years
- •Both male and female genders
- •Clinically diagnosed of stroke referred by Neuro physician
- •Patients in the chronic stage after 6 months of stroke can walk 10 meters independently.
- •Patients with anterior cerebral artery (ACA) and middle cerebral artery (MCA) involvement with the affected side being the dominant side
- •Those with Brunnstrom's recovery stages 3 and 4 will take part
- •Patients with Mini-Mental State Examination (MMS) score greater than
- •According to Modified Ashworth Scale, patients of grades 1 and 1+ will be included. Muscles that go into the spasticity include hip adductors, knee flexors and ankle plantar flexors
排除标准
- •Patients with dementia, depression or productive psychosis will not include.
- •Patients having any visual or auditory impairment will be excluded.
- •Patients with foot drop
- •Recurrent transient ischemic attack (TIA)
- •Patients with recurrent stroke
结局指标
主要结局
Stride length
时间窗: Changes from baseline Stride length at 3rd week and after 6 weeks
Distance between successive ground contacts of the same foot by using measuring tape.
Dynamic Gait Index (DGI)
时间窗: Changes from baseline Dynamic Gait Index (DGI) at 3rd week and after 6 weeks
DGI is composed of a total of 8 items. Total score is 24. In total, a score of less than 19/24 is predictive of falls in the elderly. A score of \>22 signifies a safe ambulator.
Stride length symmetry ratio
时间窗: Changes from baseline Stride length symmetry ratio at 3rd week and after 6 weeks
It will be calculated by dividing the stride length of paretic limb to non-paretic limb.
Step width
时间窗: Changes from baseline Step width at 3rd week and after 6 weeks
Transverse linear distance between two successive feet from the centers of heels by using measuring tape.
Fugl-Meyer Assessment FMA (LE)
时间窗: Changes from baseline Fugl-Meyer Assessment FMA (LE) at 3rd week and after 6 weeks
FMA is used to assess sensorimotor function which consists of maximum 28 points for lower extremity and 6 points for speed and coordination. The total summed score of 34 points indicates normal function. Higher the score more is the independence.
Gait velocity/Walking speed
时间窗: Changes from baseline Gait velocity/Walking speed at 3rd week and after 6 weeks
10 min walk test
Cadence
时间窗: Changes from baseline Cadence at 3rd week and after 6 weeks
Number of steps taken per unit time
Step length
时间窗: Changes from baseline Step length at 3rd week and after 6 weeks
Distance between successive ground contact of the opposite foot by using measuring tape.
Step length symmetry ratio
时间窗: Changes from baseline Step length symmetry ratio at 3rd week and after 6 weeks
It will be calculated by dividing step length of paretic limb to non-paretic limb.
次要结局
未报告次要终点