The Effects of Home-Based Exercise Program And Telerehabilitation on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus Applied With Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fall Risk
研究概览
简要总结
The goal of this study is to investigate effect of exercise program on balance, gait and performance in patients with normal pressure hydrocephalus applied with lumbar puncture. The main question it aims to answer are:
- Home based exercise program effective on balance, gait and performance
- Telerehabilitation exercise program effective on balance, gait and performance Researchers will compare home based exercise group, telerehabilitation group and control group to see if difference in terms of balance, gait and performance
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-90 years old
- •Fulfilling the following clinical criteria for iNPH, as proposed by the Relkin and colleagues
- •Able to walk independently (without physical assistance from a person and/or a device)
排除标准
- •Patients who had severe physical disability or immobility, major primary psychiatric disorders (eg, schizophrenia, bipolar disorder), unstable major medical illnesses (eg, acute coronary syndrome, respiratory failure), acute cerebrovascular disease, severe visual or hearing impairments were excluded.
- •Patients with diagnosis of seconder normal pressure hydrocephalus were also excluded.
结局指标
主要结局
Fall Risk
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Biodex Balance System was used to measure balance-related variables.Fall Risk test measures the patient's postural sway velocity to predict risk. There is a circular platform that moves freely and simultaneously about the anterior-posterior and medial-lateral axes and provides overall stabiliy index score. The index of overall stability is measured in degrees and higher scores indicate poor dynamic balance
Cadence
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
The test will perform with G-walk device.
Stride Length
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
The test will perform with G-walk device.
Time Up and Go Test
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
The test will perform with G-walk device.
Postural Stability
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Biodex Balance System was used to measure balance-related variables. Biodex has a fixable and movable platform and a touch screen on which the participant can visually track his/her movements.The Postural Stability test emphasizes a patient's ability to maintain center of balance. The device measures anterior-posterior (AP) and medial-lateral (ML) oscillations of the participant and provides anterior-posterior index, medial-lateral index and total stability index scores. Since these scores assess deviations from center, a lower score is more desirable than a higher score
Modified Clinical Test of Sensory Integration of Balance
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
Biodex Balance System was used to measure balance-related variables. mCTSIB provides a generalized assessment of how well patient can integrate various senses with respect to balance and compensate when one or more of those senses are compromised. mCTSIB was performed in four different conditions: eyes open-firm surface (EO-firm), eyes closed-firm surface (EC-firm), eyes open-foam surface (EO- foam), eyes closed-foam surface (EC-foam). The device computes an overall sway index as the standard deviation of the recorded position away from the center. Higher sway index scores indicate greater deviations from the center, therefore, lower scores reflect better response
Walking Speed
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
The gait characteristics was measured using G-Walk sensor system. The BTS G-Walk (G-Sensor 2) is a portable, wireless, inertial system with wearable sensors. Each participant was asked to walk down a hallway through a central 7- meter "testing" zone, instructed to walk at his/her ordinary comfortable walking speed and return start line. The acquired data is transmitted via a Bluetooth connection to a computer and processed using the special software program BTS G-Studio.
Muscle Strength
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
We measured knee extensor and ankle dorsi flexor muscle strength using a hand-held dynamometer. Participants were asked to seat on a bedside (height 100 cm) with hip and knee at 90 degree flexion. Three measurements were taken for each muscle group and the highest score was recorded in kg.
The Functional Independence Measure
时间窗: Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks
The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients.FIM is an 18-item, clinician reported scale that assesses an individuals functional capability in six areas including self-care, continence, mobility, transfers, communication and cognition.
次要结局
- Mini-mental state(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Nine-Hole Peg Test(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Lawton-Brody Instrumental Activities of Daily Living (iADL)(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Tinetti-test(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- FRAIL scale(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Clinical Dementia Rating(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Cornell Scale for Depression in Dementia (CSDD)(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Barthel scale(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Montreal Cognitive Assessment (MoCA)(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- The Geriatric Depression Scale(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- Fried frailty scale(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
- Grip strength(Change from Baseline at 24 hours after lumbar puncture, change from Baseline at 10 weeks, change from baseline at 24 weeks)
研究者
ümit yeşil
research asistant
Dokuz Eylul University