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临床试验/NCT03847454
NCT03847454已完成不适用

A Personal Mobility Device for Elderly Physical Rehabilitation: a Study of Acceptance and Efficiency

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Change in Short Physical Performance Battery (SPPB) Results

研究概览

简要总结

Developed countries are facing the challenge of ageing societies, lack of infrastructure for healthcare and high cost of care. Researchers have been attempting to answer these problems by using innovative technology to promote healthy ageing. In this trial, the investigators test the efficiency and acceptance of a personal mobility device for elderly physical rehabilitation.

The main objective of the study is to investigate whether rehabilitation using the mobility equipment is as effective as the standard care; secondly, to determine if there is an improvement in clinical outcomes such as physical strength, balance, and risk of falls after using the mobility equipment; and third, to establish whether the use of the REACH concept adds value to the continuity of patient care, specifically in terms of engagement and motivation to be more active during the hospital stay and when returning home.

详细描述

The hospital-to-home transition is increasingly recognised as a critical period in the patient care, during which different incidents can occur and induce frequent re-hospitalisation. There is therefore a growing interest in strengthening the physical and functional capacities of hospitalised elderly patients to prevent re-hospitalisation.

Researchers have extensively studied the use of computer-aided physical rehabilitation to promote physical activity. Serious games coupled with monitoring devices such as Kinect have shown to positively impact patient's motivation to do rehabilitation exercises. Whether such devices would be as efficient as the standard care in the hospital and engage the elderly to remain active after discharge is still understudied.

In the present study , the researchers aim at conducting a randomised clinical trial with 46 patients during 6 weeks, to measure the added value of the REACH concept. REACH is a H2020 funded project, the project abbreviation stands for Responsive Engagement of the Elderly Promoting Activity and Customised Healthcare.

The intervention consists of a mobility device called ActivLife developed by Alreh Medical, that is coupled with serious games, a Kinect sensor and a wearable sensor called Stepwatch, to continuously measure the patients physical activity.

The main objective of the study is to investigate whether rehabilitation using the mobility equipment is as effective as the standard care; secondly, to determine if there is an improvement in clinical outcomes such as physical strength, balance, and risk of falls after using the mobility equipment; and third, to establish whether the use of the REACH concept adds value to the continuity of patient care, specifically in terms of engagement and motivation to be more active during the hospital stay and when returning home.

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
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •seniors (65+) hospitalized in one of the involved sites at the Geneva University Hospital, with musculoskeletal issues (fracture, prosthesis, falls and low back pain), a minimal level of independence and strength (FIM >= 4 for the items regarding mobility and locomotion), and minimal level of cognitive ability (MMSE>=24); be able to interact with the equipment and be hospitalized at least 3 weeks at one of the hospitals.

排除标准

  • •patients that are considered too weak to interact with the device and that are hospitalized less than three weeks.

研究组 & 干预措施

Intervention REACH group

Experimental

The intervention REACH consists of a mobility device called ActivLife developed by Alreh Medical, that is coupled with serious games, a Kinect sensor and a wearable sensor called Stepwatch, to continuously measure the patients physical activity. The participants will receive 30 min training every day during 3 weeks. 3 times a week the standard training will be replaced with the intervention. The training is conducted/ supervised by a physiotherapist.

干预措施: REACH (Combination Product)

Control group (Standard of care)

Active Comparator

The participants will receive the standard of care as intervention which consists of 30 min training every day during 3 weeks. The training is conducted by a physiotherapist.

干预措施: Standard of care (Other)

结局指标

主要结局

Change in Short Physical Performance Battery (SPPB) Results

时间窗: 6 weeks; (at the beginning of the intervention in the hospital and after 3 weeks when the participant is leaving the hospital, and after 3 additional weeks at home)

Short Physical Performance Battery is a set of tests designed to measure functional status. and physical performance.

Change in Isometric Hand Grip Strength (IHGS) Results

时间窗: 6 weeks; (at the beginning of the intervention in the hospital and after 3 weeks when the participant is leaving the hospital, and after 3 additional weeks at home)

The purpose of the Isometric Hand Grip Strength test is to measure the maximum isometric strength of the hand and forearm muscles.

次要结局

  • Change in activity over 6 weeks(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Antoine Geissbuhler

Chair of the division of eHealth and telemedicine

University Hospital, Geneva

研究点 (1)

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