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

Phase

N/A

Condition

Osteoporosis

Treatment

Phase I - Early gait rehabilitation

Preliminary Phase

Phase II - Maintenance gait function ( with VR)

Clinical Study ID

NCT06025981

SWalker-II-VR

All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Cognitive status insufficient to understand and execute instructions given by thephysiotherapist.
Patients needing rehabilitation after hip fracture may vary from a few days to afew weeks after the period of occurrence of the hip fracture, depending on thecomplications that could arise and the type of surgery used, with a pre-set limitof one month.

Study Design

Phase I - Early gait rehabilitation

January 10, 2023

December 30, 2023

Study 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.

Connect with a study center

Werium Assistive Solutions
Arganda Del Rey, Madrid 28500
Spain
Site Not Available
Albertia Servicios Sociosanitarios
Madrid, 28222
Spain
Site Not Available

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