Assessment of the Effectiveness of Robotic Neurorehabilitation Treatment in Patients With Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- SARA (Scale for the Assessment and Rating of Ataxia)
研究概览
简要总结
This interventional study evaluates the effectiveness of robot-assisted neurorehabilitation in patients with ataxia. Participants will receive a structured robotic neurorehabilitation treatment program, and changes in motor function, coordination, balance, gait, and functional performance will be assessed using clinical outcome measures before and after the intervention.
详细描述
Ataxia is a neurological condition characterized by impaired coordination, balance, gait, and motor control, which can significantly affect functional mobility and activities of daily living. Robot-assisted neurorehabilitation may provide intensive, repetitive, and task-specific training to support motor learning and functional improvement.
The purpose of this interventional study is to evaluate the effectiveness of robot-assisted neurorehabilitation treatment in patients with ataxia. Participants will undergo a structured neurorehabilitation program using robotic technology as part of their rehabilitation treatment. Clinical and functional assessments will be performed before and after the intervention to evaluate changes in motor function, coordination, balance, gait performance, and functional mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults diagnosed with ataxia
- •Age 18 years or older
- •Ability to participate in a robot-assisted neurorehabilitation program
- •Stable clinical condition allowing participation in rehabilitation treatment
- •Ability to understand and follow study instructions
- •Ability to complete the planned clinical and functional assessments
- •Written informed consent provided by the participant
排除标准
- •Severe cognitive impairment preventing cooperation with the intervention or assessments
- •Severe musculoskeletal or neurological condition that prevents safe participation in robot-assisted rehabilitation
- •Unstable cardiovascular, respiratory, or other medical condition contraindicating rehabilitation treatment
- •Severe pain or orthopedic limitation preventing participation in the rehabilitation program
- •Severe visual or vestibular impairment that would interfere with study assessments
- •Acute medical condition or acute neurological deterioration at the time of enrollment
- •Participation in another interventional clinical study that could affect the study outcomes
- •Pregnancy, if participation is considered unsafe by the investigator
- •Any condition judged by the investigator to make participation unsafe or unsuitable
结局指标
主要结局
SARA (Scale for the Assessment and Rating of Ataxia)
时间窗: 6 months
The SARA (Scale for the Assessment and Rating of Ataxia) is a clinically validated tool used to quantify the severity of ataxia (coordination disorders) and to track the progression of patients over time.The scale consists of 8 tasks with a maximum total score of 40 points. A score of 0 indicates no ataxia, while 40 represents the most severe stage of ataxia.The 8 Items of the SARA Scale1. Gait (0-8 points): Assesses walking forward, turning, and tandem walking.2. Stance (0-6 points): Measures stability with feet apart, feet together, and in tandem stance.3. Sitting (0-4 points): Evaluates balance on a solid surface with eyes open and arms hanging loosely.4. Speech disturbance / Dysarthria (0-4 points): Rates the clarity and rhythm of speech during standard conversation.5. Finger-to-nose test (0-4 points): Measures movement accuracy and tremor for each arm separately.6. Finger-to-finger test (0-4 points): Assesses coordination as the patient repeatedly touches the clinician's finger.7
Modified Rankin Scale
时间窗: 6 month
The Modified Rankin Scale (mRS) is a standard clinical tool used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological conditions.The Scale Grades (0-6 Points)0 - No symptoms at all: The patient feels completely normal with no residual effects.1 - No significant disability despite symptoms: Able to carry out all usual duties and activities.2 - Slight disability: Unable to carry out all previous activities, but able to look after own affairs without assistance.3 - Moderate disability: Requiring some help, but able to walk without assistance from another person.4 - Moderately severe disability: Unable to walk without assistance and unable to attend to own bodily needs without assistance.5 - Severe disability: Bedridden, incontinent, and requiring constant nursing care and attention.6 - Dead: The patient has passed away.
Barthel Index
时间窗: 6 months
The Barthel Index (BI) is a widely used clinical scale that measures a patient's functional independence in performing 10 basic Activities of Daily Living (ADL). It is commonly used in stroke rehabilitation, geriatrics, and chronic care to assess self-care abilities and mobility.The total score ranges from 0 to 100 points (in increments of 5), where 0 represents complete dependence and 100 represents complete independence.The 10 Items of the Barthel Index1. Feeding (0, 5, 10 points): Ability to eat food when served (cutting, using utensils).2. Bathing (0, 5 points): Ability to wash oneself in a tub, shower, or sponge bath.3. Grooming (0, 5 points): Ability to wash hands/face, comb hair, shave, and clean teeth.4. Dressing (0, 5, 10 points): Ability to put on, fasten, and take off all clothing and shoes.5. Bowels (0, 5, 10 points): Control over bowel movements (no accidents, or requires assistance/enema).6. Bladder (0, 5, 10 points): Control over bladder function (dry day and night, or
次要结局
- 6-Minute Walk Test (6MWT)(6 months)
- Posturography(6 months)
- Functional Independence Measure (FIM)(6 months)
研究者
Tollár József
Head of Department
Somogy Megyei Kaposi Mór Teaching Hospital