Clinical Study of the Effects of a SWalker II and VR for Hip Fracture Rehabilitation in the Elderly

NCT ID: NCT06025981

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-12-30

Brief Summary

This project is structured in two distinct phases. The first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of gait. In the first phase, the aim is to evaluate the effects of the use of the robotic device (SWalker) on the physical improvement of the patient. While in the second phase, the objective is to evaluate the effects of virtual reality technology combined with the use of the SWalker.Therefore, the following specific objectives are identified:

• Phase I: To analyze the effects of SWalker application in patients with acute hip fracture on clinical parameters of rehabilitation.
• Phase II: To study the effects of the application of the SWalker combined with immersive technology in people with impaired gait function after hip fracture.

Detailed Description

In the preliminary phase, the usability and acceptance of the SWalker II system combined with virtual reality is evaluated with a group of healthy subjects. For this purpose, an exposure session and the evaluation of the system based on questionnaires are carried out. On the other hand, a gait characterization session (capture of ROM and EMG) is performed inside and outside the walker with different speeds and weight loads.

In the first phase of the clinical study, patients with hip fractures in the early rehabilitation phase were recruited. They are randomly assigned to a control group or experiment group. And for a period of 6 weeks, both groups carry out the same rehabilitation exercise program based on strength, balance and ambulation exercise. The difference is that the experimental group performs the rehabilitation exercises with the SWalker, and the control group performs these exercises with conventional parallel bars.

In the second phase of the clinical study, these same patients who have passed the first pass, move on to a 6-weeks program of maintenance and improvement of gait function. Again, they are divided into 2 groups, control and experimental. So the control group will perform walking exercises with the Swalker and conventional balance exercises and the experimental group will perform walking and balance exercises with SWalker and virtual reality.

Conditions

Hip Fractures; Gait Disorders in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Preliminary Phase

20 healthy subjects will perform an experimental session for characterization of functional status with clinical scales; characterization of gait with SWalker using ROM and EMG at different speeds and weight bearing; and assessment of system usability with VR using standardized questionnaires.

Group Type: OTHER

Preliminary Phase

Intervention Type: OTHER

In the preliminary phase, the characterization of the functionality of the SWalker robotic system, as well as the functionality of the Virtual Reality system, will be carried out. All descriptive usability questionnaires completed by the participants and electro-biomechanical parameters will be collected using the robot's measurement systems to analyze the functionality.

Phase I and II

In both phases 100 subjects will perform a gait rehabilitation intervention program (phase 1) and maintenance (phase 2), in which they will employ the use of the robotic walker and virtual reality depending on the group and phase. The evolution of functional clinical parameters will be studied for both groups and phases.

Group Type: OTHER

Phase I - Early gait rehabilitation

Intervention Type: OTHER

In the first phase, the participants will carry out the rehabilitation program for hip fracture in acute phase that will last 6 weeks. Participants will be randomized between control and experimental groups. In which the therapeutic intervention is based on the usual rehabilitation guidelines that integrate exercises aimed at improving strength, gait, functional mobility and balance. In the case of the experimental group, a robotic walker will be used to practice walking.

Phase II - Maintenance gait function ( with VR)

Intervention Type: OTHER

In the second phase, participants will carry out a 6-week program to consolidate walking function. Participants will be randomized between control and experimental groups. In which the therapeutic intervention is based on the use of the robotic system for gait exercise. In the case of the experimental group, the use of virtual reality will also be integrated.

Interventions

Preliminary Phase

In the preliminary phase, the characterization of the functionality of the SWalker robotic system, as well as the functionality of the Virtual Reality system, will be carried out. All descriptive usability questionnaires completed by the participants and electro-biomechanical parameters will be collected using the robot's measurement systems to analyze the functionality.

Intervention Type: OTHER

Phase I - Early gait rehabilitation

In the first phase, the participants will carry out the rehabilitation program for hip fracture in acute phase that will last 6 weeks. Participants will be randomized between control and experimental groups. In which the therapeutic intervention is based on the usual rehabilitation guidelines that integrate exercises aimed at improving strength, gait, functional mobility and balance. In the case of the experimental group, a robotic walker will be used to practice walking.

Intervention Type: OTHER

Phase II - Maintenance gait function ( with VR)

In the second phase, participants will carry out a 6-week program to consolidate walking function. Participants will be randomized between control and experimental groups. In which the therapeutic intervention is based on the use of the robotic system for gait exercise. In the case of the experimental group, the use of virtual reality will also be integrated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants of both sexes over 65 years of age,
• Patients with a height of less than 180 cm,
• Patients weighing less than 90 kg,
• Patients who have suffered a hip fracture* and wish to participate in the study.
• In addition, they must sign and understand the informed consent form.

Exclusion Criteria

• Cognitive status insufficient to understand and execute instructions given by the physiotherapist.

• Patients needing rehabilitation after hip fracture may vary from a few days to a few weeks after the period of occurrence of the hip fracture, depending on the complications that could arise and the type of surgery used, with a pre-set limit of one month.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Werium Assistive Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Werium Assistive Solutions

Arganda, Madrid, Spain

Albertia Servicios Sociosanitarios

Madrid, , Spain

Countries

Spain

References

Costa V, Rojo A, Lopez-Lopez S, Pareja-Galeano H, Velasquez A, Perea L, Raya R. Evaluating the Usability and Safety of Virtual Reality Application Combined with the SWalker for Functional Gait Rehabilitation. Games Health J. 2024 Oct;13(5):397-405. doi: 10.1089/g4h.2023.0172. Epub 2024 May 17.

Reference Type: DERIVED

PMID: 38757664 (View on PubMed)

Other Identifiers

SWalker-II-VR

Identifier Type: -

Identifier Source: org_study_id