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Completed

NCT Number: NCT03847454

REACH Personal Mobility Device Testing

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

REACH

Combination Product

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.

Standard of care

Other

Standard of care for rehabilitation treatment for musculoskeletal patients.

Primary outcomes

  1. Change in Short Physical Performance Battery (SPPB) Results

    Time frame: 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.

  2. Change in Isometric Hand Grip Strength (IHGS) Results

    Time frame: 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.

Secondary outcomes

  1. Change in activity over 6 weeks

    Time frame: 6 weeks

    Measurement of activity level with stepwatch sensor. Continuous measurement of steps from participants with stepwatch sensor.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: REACH

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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