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

NCT06025981 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-06

No results posted yet for this 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.

Conditions

  • Hip Fractures
  • Gait Disorders in Old Age

Interventions

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.

Sponsors & Collaborators

  • Werium Assistive Solutions

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-01-30
Completion
2023-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06025981 on ClinicalTrials.gov