REACH Personal Mobility Device Testing

NCT03847454 | Completed

• 1 other identifier: 2018-01516
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Diseases or Conditions; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in activity over 6 weeks

  6 weeks

Study Arms (2)

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.

Combination Product: REACH

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.

Other: Standard of care

Interventions

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.

Intervention REACH group

Standard of care OTHER

Standard of care for rehabilitation treatment for musculoskeletal patients.

Control group (Standard of care)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

Location

Related Publications (1)

• Randriambelonoro M, Perrin Franck C, Herrmann F, Carmona GA, Geissbuhler A, Graf C, Frangos E. Gamified Physical Rehabilitation for Older Adults With Musculoskeletal Issues: Pilot Noninferiority Randomized Clinical Trial. JMIR Rehabil Assist Technol. 2023 Mar 6;10:e39543. doi: 10.2196/39543.

  PMID: 36877563 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the division of eHealth and telemedicine

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 20, 2019
• Study Start: February 27, 2019
• Primary Completion: August 12, 2019
• Study Completion: September 5, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

CH (1)