REACH Personal Mobility Device Testing (REACH)

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Combination product: REACH; Other: Standard of care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention REACH group; 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.	Combination product: REACH; 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.
Active Comparator: Control group (Standard of care); 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.	Other: Standard of care; Standard of care for rehabilitation treatment for musculoskeletal patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Short Physical Performance Battery (SPPB) Results	Short Physical Performance Battery is a set of tests designed to measure functional status. and physical performance.	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)
Change in Isometric Hand Grip Strength (IHGS) Results	The purpose of the Isometric Hand Grip Strength test is to measure the maximum isometric strength of the hand and forearm muscles.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activity over 6 weeks	Measurement of activity level with stepwatch sensor. Continuous measurement of steps from participants with stepwatch sensor.	6 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 2018-01516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No