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REACH Personal Mobility Device Testing (REACH)

Primary Purpose

Musculoskeletal Diseases or Conditions, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
REACH
Standard of care
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases or Conditions

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention REACH group

Control group (Standard of care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in activity over 6 weeks
Measurement of activity level with stepwatch sensor. Continuous measurement of steps from participants with stepwatch sensor.

Full Information

First Posted
January 29, 2019
Last Updated
March 24, 2020
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT03847454
Brief Title
REACH Personal Mobility Device Testing
Acronym
REACH
Official Title
A Personal Mobility Device for Elderly Physical Rehabilitation: a Study of Acceptance and Efficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases or Conditions, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention REACH group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (Standard of care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
REACH
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care for rehabilitation treatment for musculoskeletal patients.
Primary Outcome Measure Information:
Title
Change in Short Physical Performance Battery (SPPB) Results
Description
Short Physical Performance Battery is a set of tests designed to measure functional status. and physical performance.
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)
Title
Change in Isometric Hand Grip Strength (IHGS) Results
Description
The purpose of the Isometric Hand Grip Strength test is to measure the maximum isometric strength of the hand and forearm muscles.
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)
Secondary Outcome Measure Information:
Title
Change in activity over 6 weeks
Description
Measurement of activity level with stepwatch sensor. Continuous measurement of steps from participants with stepwatch sensor.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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REACH Personal Mobility Device Testing

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