Investigation of the Effects of Vestibular Rehabilitation and Dynamic Neuromuscular Stabilization Exercises on Balance and Mobility in Patients With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Fugl-Meyer Assessment of Upper Extremity
研究概览
简要总结
This study will aim to investigate the effects of vestibular rehabilitation, dynamic neuromuscular stabilization (DNS), and conservative rehabilitation exercises on balance and mobility in hemiplegic patients, and to compare the exercise programs with one another. Evaluation tools include the Brunnstrom Motor Staging, Fugl-Meyer Upper Extremity Motor Function Scale, Modified Ashworth Scale, Mini-Mental State Examination, Berg Balance Scale, Stroke Impact Scale, and Timed Up and Go test.
详细描述
This study will aim to investigate the effects of vestibular rehabilitation, dynamic neuromuscular stabilization (DNS), and conservative rehabilitation exercises on balance and mobility in hemiplegic patients, and to compare the exercise programs with one another. A total of 45 hemiplegic patients will enrolled and randomized into three groups: Conventional Exercise Group (CEG, n = 15), Dynamic Neuromuscular Stabilization Group (DNSG, n = 15), and Vestibular Rehabilitation Group (VRG, n = 15). Each group will be participated in specialized exercise programs twice a week for six weeks. All groups will be underwent assessments before and after treatment. Evaluation tools include the Brunnstrom Motor Staging, Fugl-Meyer Upper Extremity Motor Function Scale, Modified Ashworth Scale, Mini-Mental State Examination, Berg Balance Scale, Stroke Impact Scale, and Timed Up and Go test.
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)
盲法说明
Outcomes Assessor will be masked in the assesment part in the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or older
- •Having experienced at least one stroke and presenting with hemiplegic symptoms
- •Having passed at least one year since the stroke even
- •Scoring at least 24 points on the Mini-Mental State Examination (MMSE)
- •Being able to walk independently for at least 30 meters without assistance
- •Being able to comply with and participate in the exercise program
排除标准
- •Individuals with chronic pulmonary and/or cardiac diseases
- •Presence of uncontrolled hypertension
- •Conditions accompanied by peripheral nerve injury or lower motor neuron disorders
- •Presence of additional neurological disorders such as ataxia, dyskinesia, or dystonia
- •Severe spasticity, peripheral lesions, pressure ulcers, marked muscle atrophy, obesity, skin irritation, or use of a cardiac pacemaker
- •Presence of vestibular symptoms such as vertigo or dizziness
研究组 & 干预措施
Group 1: Conventional Exercise Group
Conventional Exercise will be conducted in this group
干预措施: Conventional Exercise programs (Other)
Group 2: Dynamic Neuromuscular Stabilization Group
Dynamic Neuromuscular Stabilization exercises will be done in this group
干预措施: Dynamic Neuromuscular Stabilization (Other)
Group 3: Vestibular Rehabilitation Group
Vestibular Rehabilitation will be conducted in this group
干预措施: Vestibular Rehabilitation Group (Other)
结局指标
主要结局
The Fugl-Meyer Assessment of Upper Extremity
时间窗: From the beginning of treatment to the end of the 6th week
It is a standardized, stroke-specific, performance-based outcome measure used in clinical trials to evaluate motor recovery of the upper limb. It assesses movement, coordination, and reflex activity of the shoulder, elbow, forearm, wrist, and hand, providing a quantitative measure of motor impairment and recovery over time. The maximum score for the arm section is 36. During the finger-to-nose test, coordination and speed of movement are evaluated out of 6 points, while tremor, dysmetria, and speed of movement in the upper extremity are also examined in detail.
Modified Ashworth Scale (MAS)
时间窗: From the beginning of treatment to the end of the 6th week
It is a widely used clinical outcome measure in clinical trials to assess spasticity by grading the resistance encountered during passive muscle stretching. The joint is passively moved with repetitive and rapid movements, and the joint's resistance to these movements is scored.
Mini-Mental State Examination (MMSE)
时间窗: From the beginning of treatment to the end of the 6th week
It is a brief, standardized cognitive screening tool used in clinical trials to assess global cognitive function, including orientation, attention, memory, language, and visuospatial abilities. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Scores of 24-30 indicate normal cognition, 18-23 mild cognitive impairment, and ≤17 moderate to severe cognitive impairment.
Berg Balance Scale (BBS)
时间窗: From the beginning of treatment to the end of the 6th week
This is a 14-item scale that assesses a patient's ability to maintain balance for a specific period during static and various functional movements. The scoring system ranges from 0 to 4, with 0 meaning "cannot" and 4 meaning "can do independently," and the maximum total score is 56. A total score between 0-20 indicates a high risk of falls; between 21-40 indicates a moderate risk of falls; and between 41-56 indicates a low risk of falls.
Stroke Impact Scale (SIS)
时间窗: From the beginning of treatment to the end of the 6th week
It is a stroke-specific, patient-reported outcome measure widely used in clinical trials to evaluate the perceived impact of stroke on multiple domains of health-related quality of life. Based on the obtained score, 0 indicates no recovery, whereas 100 represents complete recovery.
Timed Up and Go (TUG)
时间窗: From the beginning of treatment to the end of the 6th week
The test is a simple and widely used functional mobility assessment in clinical trials. It measures the time required for an individual to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better functional mobility and balance, and the test is commonly used to assess fall risk and mobility limitations.
次要结局
未报告次要终点
研究者
merve yilmaz menek
Assoc. Prof
Istanbul Medipol University Hospital