Clinical trial NCT06025981: Clinical Study of the Effects of a SWalker II and VR for Hip Fracture Rehabilitation in the Elderly
Official title: Clinical Study of the Effects of a Robotic Walker and Immersive Technology for Hip Fracture Rehabilitation in the Elderly
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hip Fractures
Gait Disorders in Old Age
Lead sponsor: Werium Assistive Solutions
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The model is that of a prospective, longitudinal, multicenter, randomized controlled trial (RCT), open-label and analytical:

* RCT: A rehabilitation intervention with SWalker (experimental group) and a conventional one (control group) will be implemented, following randomization.
* Prospective longitudinal: Study requiring follow-up of patients during the hip fracture rehabilitation period.
* Open multicenter: Inclusion is not limited to any individual who meet the inclusion criteria from Valle de la Oliva-Majadahonda, Ciempozuelos, Mirasierra and Moratalaz nursing homes.
* Analytical: Results are presented in a descriptive way and entering into the analytical statistics of comparison and relationship. analytical comparison and relationship.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Pain
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Ambulation
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Strength
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Gait
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Fear of falling
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Quality of life.
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Mobility
timeFrame: 6 weeks
measure: Effects of robotic system (SWalker + VR) use in gait rehabilitation - Gait and Balance
timeFrame: 6 weeks
Secondary outcomes:
measure: Usability of virtual reality system combined with the robotic system (SWalker) - Presence
timeFrame: 1 week
measure: Usability of virtual reality system combined with the robotic system (SWalker) - Safety
timeFrame: 1 week
measure: Feasibility of robotic system (SWalker) - Gait
timeFrame: 1 week
measure: Feasibility of robotic system (SWalker) - Hip ROM
timeFrame: 1 week
measure: Usability of virtual reality system combined with the robotic system (SWalker) - Usability
timeFrame: 1 week
measure: Feasibility of robotic system (SWalker) - Gait and Balance
timeFrame: 1 week
measure: Feasibility of robotic system (SWalker) - Physical Performance
timeFrame: 1 week
measure: Feasibility of robotic system (SWalker) - EMG activity
timeFrame: 1 week
Other outcomes:
Locations:
city: Arganda Del Rey
country: Spain
facility: Werium Assistive Solutions
state: Madrid
city: Madrid
country: Spain
facility: Albertia Servicios Sociosanitarios
Study officials:
References: