NCT06025981

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

Clinical Study of the Effects of a Robotic Walker and Immersive Technology for Hip Fracture Rehabilitation in the Elderly

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Werium Assistive Solutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.
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.

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-01-30
• Completion: 2023-12-30
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

2 sites across 1 country: Spain