The Intelligent Community Active Rehab for the Elderly Study Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Total number of events fall at 3 months.
研究概览
简要总结
Conducting assessment lower limb muscle strength, power and joint range of movement as well as inertial measurement unit (IMU) data capture during periods of walking and activities of daily living (sit to stand, stand to sit, climbing stairs) in participants over the age of 65. Assessing to see if there is any correlation between prospective follow up for incidence of fall events and patterns observed in the IMU data of the subject and to assess if the IMU data observed that results in higher or lower incidence of falls is related to any particular pattern in lower limb muscle strength, power and joint range of movement data.
详细描述
Research Question:
• What is the feasibility of conducting a large scale study to identify modifiable musculoskeletal factors, increasing the risk of falls in older adults; that can be detected in mobility data collected from a wearable device worn during activities of daily living?
Primary aim:
• To collect feasibility data on study processes, resource and management.
Secondary aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 65 years of age
- •Able to give informed consent
- •Able to mobilise independently or with mobility aid (walking stick, Zimmer frame etc.)
排除标准
- •Patients under the age of
- •Patients who are bedbound or wheelchair bound.
- •Patients with cognitive impairment and are unable to give informed consent.
- •Significant medical co-morbidities that make participation in the study unsafe.
结局指标
主要结局
Total number of events fall at 3 months.
时间窗: Recorded at day 90.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 1 week.
时间窗: Recorded at day 7.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 1 month.
时间窗: Recorded at day 30.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 6 months.
时间窗: Recorded at day 180.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 2 weeks.
时间窗: Recorded at day 14.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
次要结局
- Timed stair climb(Completed at Day 1 and at the 6 months follow up.)
- Short musculoskeletal function assessment (SMFA) questionnaire(Completed at Day 1 and at the 6 months follow up.)
- Timed up and go test (TUG test)(Completed at Day 1 and at the 6 months follow up.)
- Physical activity scale for the elderly (PASE) questionnaire(Completed at Day 1 and at the 6 months follow up.)
- Previous fall event history questions(Completed at Day1.)
- Thirty second sit to stand test(Completed at Day 1 and at the 6 months follow up.)
- 2 min walk test(Completed at Day 1 and at the 6 months follow up.)
- Grip strength(Completed at Day 1 and at the 6 months follow up.)
研究者
Kalon Hewage, MBBS BSc MSc MRCS
Director and Co-Founder Cush Health, Trauma and Orthopaedic Registrar
CUSH Health Ltd.