Walking Pattern Characteristics in Normal Pressure Hydrocephalus. A Phase I/II Open-label Single Center Trial to Characterize Disease-specific Walking Patterns Using Wearable Gyroscopes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Walking characteristics
研究概览
简要总结
20 patients who are diagnosed with NPH receive a set of 5 wearable gyroscopes (IMUs, ZurichMove sensors) for a period of 3 days for measurement and characterization of their walking in an ambulatory setting. At a follow-up 2 weeks to 6 months after CSF diversion surgery, the examination is repeated and improvement is measured. The data will be compared with a healthy group of 20 age- and gender-matched individuals as well a a group of 20 young individuals.
详细描述
Temporary attachment of IMUs to wrists and ankles of the patients and probands for a period of three days and recording of movement during a 10 meter-walking test, 180° turnaround and during normal movement at home.
Group 1 (patients):
Patients with a completed diagnostic concerning iNPH, who are planned to receive a VP-shunt by their responsible neurosurgeon (independently from the study), will be included.
Before the shunt implantation, the patients will be examined at the USZ using wearable gyroscopes (like wristwatches) at both wrists and ankles as well as one around the body center.
The short examination will comprise a patient history (MoCa test, Kiefer-score, Stein- and Langfitt-Score), a short examination (4 minute walking test, 180° turnaround) in hospital. Afterwards, the patient goes home, where the gyroscopes examine walking patterns for a period of three days. After this period, the patient brings the devices back to the hospital. The surgery will take place afterwards, independently from the study, as well as adjustments of the shunt's flow-resistance for achievement of optimal response to the therapy. After this optimal result is achieved, but latest after 6 months, the examination will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
unmasked
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age limits for the NPH patient group and the matched healthy vonunteers group are 60-100 years.
- •Age limits for the young healthy volunteers group are 18-40 years.
- •Inclusion Criteria:
- •NPH patient group:
- •Informed Consent as documented by signature prior to any study related procedures or informed consent by a legal representative in case of cognitive deficits.
- •Male and female patients alike
- •Age between 60 and 100 years
- •Clinical suspect for NPH
- •Significant improvement (by more than 10%) in walking speed or endurance in a standardized CSF-TAP test (of at least 35 ml CSF).
- •Planned implantation of a VP shunt for NPH treatment (independently from the study).
- •Matched controls group:
- •Informed Consent as documented by signature prior to any study related procedures
- •Male and female patients alike (matched to group 1)
- •Age between 60 and 100 years (matched to group 1)
- •No clinical suspect for NPH or any other movement disorder
- •Young controls group:
- •Informed Consent as documented by signature prior to any study related procedures
- •Male and female patients alike (matched to group 1)
- •Age between 18 and 40 years
- •No clinical suspect for NPH or any other movement disorder
排除标准
- •Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
- •Apparent or suspected movement disorder or other known disorder, which might affect normal standing or walking
- •Cardiovascular disorders, which might affect physical resilience
- •Pregnant women
- •Pre-menopausal state of female patients and probands in groups 1 and
- •Children and adolescents
研究组 & 干预措施
iNPH patients
20 patients with completed diagnostics concerning NPH, in which the indication for implantation of a VP shunt for NPH treatment was found by the responsible surgeon independently from the study.
干预措施: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) (Device)
Healthy volunteers
20 volunteers, matched with group 1 concerning sex and age.
干预措施: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) (Device)
Young healthy volunteers
20 volunteers, matched with group 1 concerning sex only and between 18 and 40 years old.
干预措施: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) (Device)
结局指标
主要结局
Walking characteristics
时间窗: Between 2 weeks to 6 months after CSF diversion surgery
Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)
次要结局
- 4 minutes timed Walk test(immediately after fixation of IMUs)
- Evan´s Index(before surgery)
- Time from appearance of first symptoms to surgery(before surgery)
- 3-dimensional characterization of walking patterns(after surgery (range 2 weeks to 6 months))
- Kiefer score(after surgery (range 2 weeks to 6 months))
- Stein and Langfitt score(after surgery (range 2 weeks to 6 months))
- NPH recovery rate(after surgery (range 2 weeks to 6 months))
- Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign(before surgery)
- 180 degree turnaround test(immediately after fixation of IMUs)
- Kiefer score(before surgery)
- Stein and Langfitt score(before surgery)
- 3-dimensional characterization of walking patterns(before surgery)