Gait Pattern, Experienced Global Change, Sense of Coherence, Quality of Life, Anxiety and Depression Symptoms After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus, in Relation With Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).
研究概览
简要总结
Part 1 Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable disabilities regarding gait, balance, cognition and continence. Analysis of the gait pattern in iNPH has an important part in clinical diagnosing and evaluation of outcome after shunt surgery. The gait pattern is only partly explained and more detailed information about gait in iNPH is needed in relation with ordinary clinical measurements.
Part 2 Approximately 70 % of patients with iNPH improve after shunt surgery. Commonly different grading scales and measurements regarding functions are used in the evaluation. To some extent, patients improve in Quality of life after surgery (QoL). In this study, the patient´s own grading of improvements in relation with QoL, sense of coherence (SOC) and symptoms of depression and anxiety are analyzed.
详细描述
Consecutive patients with iNPH, which are planed for shunt surgery at the neurological and neurosurgical departments of University Hospital of Linköping, are included. Before operation and 3 months postoperatively, the patient´s gait pattern are analyzed with RehaGait analysis system. The patients also fill in a questionnaire about SOC, QoL and symptoms of depression and anxiety at these assessment sessions. Additionally at the follow up, the patients are grading their overall experienced change and specified changes in gait, balance, continence and neuropsychology with the global Rating of Change Scale (GRC-scale). At baseline and at follow up, the patients also perform the ordinary clinical assessments with measurements covering the domains gait, balance, continence and neuropsychology in the iNPH-scale. A convenience sample of Healthy individuals aged > 60 years, conduct the same questionnaires: SOC, QoL and symptoms of depression and anxiety and perform the RehaGait analysis system once.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride duration (seconds)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride length (cm)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Circumduction (cm)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Knee joint angle (degree of angle)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Grading of severity in idiopathic normal pressure hydrocephalus assessed with the Idiopathic Normal Pressure Hydrocephalus Scale
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1 and part 2. Scores 0-100, higher scores mean a better outcome.
Rating of global change assessed with the Global Rating of Change Scale
时间窗: Rating at 3 month follow-up for patients.
Measurement in part 2. Scores -5-5 in global change, gait, balance, continence and cognition. Higher scores mean a better outcome.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Heel strike and Toe of angle (angle degree)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Ankle joint angle (degree of angle)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Gait phases (seconds)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Mobility, walking ability and balance assessed with the Timed up and Go test
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Variables: Time in seconds and number of steps.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed distance (m)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Cadence (steps per minute)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable:Hip joint angle (degree of angle)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Sense of Coherence assessed with the 29 item Orientation to life questionnaire - swedish version (KASAM questionnaire)
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Scores 29-203, higher scores mean a better outcome.
Anxiety and depression assessed with the Hospital Anxiety and Depression Scale
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Anxiety scores 0-21, Depression scores 0-21, lower scores mean a better outcome.
Health-related quality of life assessed with EQ-5D-5L
时间窗: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Scores 5-25, higher scores mean a better outcome.
次要结局
未报告次要终点
研究者
Fredrik Lundin
Principal Investigator
Linkoeping University