Assessment of the Relationship Between the Deficit of Proprioception, Reaction Time and the Parameters of Gait and Balance in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Correlation between the knee proprioception deficit (degree) and ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)
研究概览
简要总结
The aim of this observational study is to analyze how impaired proprioception affects the gait, reaction time, balance and functioning of stroke patients.
Research questions:
- Are there correlations between the deficit of proprioception and reaction time and the parameters of gait and balance as well as the functional state of stroke patients?
- Are there relationships between factors such as proprioception, reaction time, balance, functional status and gait, and time since stroke, the hemisphere where the stroke occurred, and gender?
- Are there differences in proprioception deficits and reaction times between the lower limbs in stroke survivors?
Participants will be assessed once using standard functional clinical tests and the rehabilitation devices.
Researchers will compare stroke patients and healthy volunteers to see, if there are differences in proprioception deficits, reaction time and balance.
详细描述
For this prospective observational study, ischemic - stroke survivors (study group) and healthy volunteers matched for age and gender (control group) will be recruited. Study procedures will be performed in the morning including one-time functional assessment of proprioception, gait, balance and reaction time using standard clinical tests (Timed Up and Go Test, sit to stand test, 10m walk test, Wisconsin scale, Berg scale, Ashworth scale, Brunstrom scale, Barthel Scale, Rankin scale and FAC) and rehabilitation devices (Luna EMG - proprioception assessment, Pablo - gait parameters assessment, Omego Plus - proprioception assessment, ALFA stabilometric platform - balance and reaction time assessment).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed and voluntary consent of the patient,
- •first-time stroke,
- •hemiparesis,
- •time from stroke to 3 months,
- •age 30-75,
- •grade 3-5 in the Functional Ambulation Category,
- •walking without orthopedic support.
排除标准
- •lack of informed and voluntary consent of the patient,
- •second or subsequent stroke,
- •stroke of the brainstem and cerebellum,
- •epilepsy,
- •disorders of higher mental functions,
- •coexisting neurological, rheumatological, orthopedic diseases,
- •use of orthopedic supplies during locomotion.
结局指标
主要结局
Correlation between the knee proprioception deficit (degree) and ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the ambulation status will be assessed using standard clinical scale: Functional Ambulation Category. Less points indicate worse ambulation category
Correlation between the knee proprioception deficit (degree) and balance parameter: lateral sways (cm)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the lateral sways (cm) will be assessed using stabilometric platform (Alfa)
Correlation between the knee proprioception deficit (degree) and balance parameter: lateral velocity (cm/s)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the lateral velocity (cm/s) will be assessed using stabilometric platform (Alfa)
Correlation between the knee proprioception deficit (degree) and balance: Berg Balance Scale (points: minimum 0, maximum 56)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the balance will be assessed using standard clinical scale: Berg Balance Scale. Less points indicate worse balance
Correlation between the knee proprioception deficit (degree) and kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the kinematic and spatiotemporal gait parameters will be assessed using standard clinical scale: Wisconsin scale. The higher the score the more seriously affected the gait
Correlation between the knee proprioception deficit (degree) and reaction time (miliseconds)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the reaction time will be assessed using stabilometric platform (Alfa)
Correlation between the knee proprioception deficit (degree) and spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the spasticity will be assessed using standard clinical scale: Modified Ashworth Scale. Better score indicates worse spasticity
Correlation between the knee proprioception deficit (degree) and dynamic balance: Timed Up and Go Test (seconds)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the dynamic balance will be assessed using standard clinical scale Timed Up and Go Test. Longer time of performing test indicates worse dynamic balance
Correlation between the knee proprioception deficit (degree) and functional status: Rankin scale (points: minimum 0, maximum 5)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: Rankin scale. Better score indicates worse functional status
Correlation between the knee proprioception deficit (degree) and gait time: 10-meter-Walk Test (seconds)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and gait time (seconds) will be assessed using inertial sensors (Pablo device)
Correlation between the knee proprioception deficit (degree) and cycle distance (cm)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and cycle distance (cm) will be assessed using inertial sensors (Pablo device)
Correlation between the knee proprioception deficit (degree) and balance parameter: anterior-posterior sways (cm)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the anterior-posterior sways (cm) will be assessed using stabilometric platform (Alfa)
Correlation between the knee proprioception deficit (degree) and balance parameter: COP area (cm2)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the COP area (cm2) will be assessed using stabilometric platform (Alfa). COP - center of pressure
Correlation between the knee proprioception deficit (degree) and functional status: 5 times Sit To Stand Test (seconds)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: 5 times Sit To Stand Test. Longer time of performing test indicates worse functional status
Correlation between the knee proprioception deficit (degree) and functional status: Brunnstrom scale (points: minimum 1, maximum 6)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: Brunnstrom scale. Better score indicates better functional status
Correlation between the knee proprioception deficit (degree) and gait speed (m/s)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and gait speed (m/s) will be assessed using inertial sensors (Pablo device)
Correlation between the knee proprioception deficit (degree) and gait cycle (steps/minute)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and gait cycle (steps/minute) will be assessed using inertial sensors (Pablo device)
Correlation between the knee proprioception deficit (degree) and balance parameter: path length (cm)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the path length (cm) will be assessed using stabilometric platform (Alfa)
Correlation between the knee proprioception deficit (degree) and balance parameter: anterio-posterior velocity (cm/s)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the anterior-posterior velocity (cm/s) will be assessed using stabilometric platform (Alfa)
Correlation between the knee proprioception deficit (degree) and functional status: Barthel scale (points: minimum 0, maximum 100)
时间窗: September 2024
The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: Barthel. Better score indicates better functional status
次要结局
- Differences in gait time: 10-meter-Walk Test (seconds)(December 2024)
- Differences in kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)(December 2024)
- Differences in balance parameter: lateral velocity (cm/s)(December 2024)
- Differences in balance parameter: anterior-posterior velocity (cm/s)(December 2024)
- Differences in gait cycle (steps/minute)(December 2024)
- Differences in reaction time (ms).(December 2024)
- Differences in spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)(December 2024)
- Differences in gait speed (m/s)(December 2024)
- Differences in ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)(December 2024)
- Differences in balance parameter: lateral sways (cm)(December 2024)
- Differences in balance parameter: path length (cm)(December 2024)
- Differences in balance: Berg Balance Scale (points: minimum 0, maximum 56)(December 2024)
- Differences in cycle distance (cm)(December 2024)
- Differences in knee proprioception deficit (degree).(December 2024)
- Differences in balance parameter: anterior-posterior sways (cm)(December 2024)
- Differences in balance parameter: COP area (cm2)(December 2024)
- Differences in dynamic balance: Timed Up and Go Test (seconds)(December 2024)
- Differences in functional status: Barthel scale (points: minimum 0, maximum 100)(December 2024)
- Differences in functional status: 5 times Sit To Stand Test (seconds)(December 2024)
- Differences in functional status: Brunnstrom scale (points: minimum 1, maximum 6)(December 2024)
- Differences in functional status: Rankin scale (points: minimum 0, maximum 5)(December 2024)
研究者
Maciej Kochman
Principal Investigator
University of Rzeszow