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

NCT06025981 | Unknown DMC

• 1 other identifier: SWalker-II-VR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures; Gait Disorders in Old Age

Outcome Measures

Primary Outcomes (8)

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Pain

  The evolution of the functional clinical scales will be studied (pain): Pain by means of the Verbal Rating Scale, a five-point scale and consists of a list of adjectives describing various levels of symptom intensity (0= no itch, 1= mild itch, 2= moderate itch , 3= severe itch and 4=very severe itch).

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Ambulation

  The evolution of the functional clinical scales will be studied (autonomy/independence): Functional limitation in early post-acute phase by means of Cumulative Ambulation Score (CAS) (Physical test). The CAS describes the patient's independence with regard to three activities (getting in and out of bed, sit-to-stand-to-sit from a chair, and walking). Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from 0 to 6.

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Strength

  The evolution of the functional clinical scales will be studied (strength): Muscle strength of the lower limbs through quadriceps extension test or lower limb dynamometer (physiological parameter).

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Gait

  The evolution of the functional clinical scales will be studied (gait and balance): Gait speed using the 10 metre Walk Test (10MWT) (physical test), provided the patient can walk without human assistance; The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. The total time is recorded in m/s. Household Ambulator \<0.40 m/s; Limited Community Ambulator 0.40 to \<0.80 m/s; Community Ambulator ≥0.80 m/s.

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Fear of falling

  The evolution of the functional clinical scales will be studied (autonomy/independence): Fear of falling by means of the Falls Efficacy Scale International (questionnaire); The total score ranges from 16 to 64, where 16 indicates "no concern" and 64 indicates "extremely concerned about falling" during the performance of the specific activities suggested by the questionnaire.

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Quality of life.

  The evolution of the functional clinical scales will be studied (autonomy/independence): Quality of life through the 36-Item Short Form Survey (SF-36) (questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Mobility

  The evolution of the functional clinical scales will be studied (autonomy/independence): Mobility using the New Mobility Test (Physical test), also known as Parker Mobility Test. It is a composite score of the patient's ability to perform: indoor walking, outdoor walking, and shopping, providing a score between 0 and 3 (0 - not at all, 1 - with help from another person, 2 - with an aid, 3 - no difficulty) for each function, resulting in a total score from 0 (no walking ability at all) to 9 (fully independent) .

  6 weeks

• Effects of robotic system (SWalker + VR) use in gait rehabilitation - Gait and Balance

  The evolution of the functional clinical scales will be studied (gait and balance): Functionality through the Timed Up \& Go test (physical test). Its score is the time spent (seconds) while the subject is standing from an armchair, walking 3 meters, returning to the chair walking 3 additional meters and sitting down. It is considered that scores of 10 seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance.

  6 weeks

Secondary Outcomes (8)

• Usability of virtual reality system combined with the robotic system (SWalker) - Presence

  1 week

• Usability of virtual reality system combined with the robotic system (SWalker) - Safety

  1 week

• Feasibility of robotic system (SWalker) - Gait

  1 week

• Feasibility of robotic system (SWalker) - Hip ROM

  1 week

• Usability of virtual reality system combined with the robotic system (SWalker) - Usability

  1 week

Study Arms (2)

Preliminary Phase

OTHER

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.

Other: Preliminary Phase

Phase I and II

OTHER

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.

Other: Phase I - Early gait rehabilitation; Other: Phase II - Maintenance gait function ( with VR)

Interventions

Preliminary Phase 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.

Preliminary Phase

Phase I - Early gait rehabilitation 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 I and II

Phase II - Maintenance gait function ( with VR) 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.

Phase I and II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Werium Assistive Solutions: lead

Study Sites (2)

Werium Assistive Solutions

Arganda, Madrid, 28500, Spain

Location

Albertia Servicios Sociosanitarios

Madrid, 28222, Spain

Location

Related Publications (1)

• 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.

  PMID: 38757664 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: September 6, 2023
• Study Start: January 10, 2023
• Primary Completion: January 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)