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Does Virtual Reality Rehabilitation Improve Mobility, Balance, and Walking in Patients With Total Hip Arthroplasty?

M

Mauro Crestani

Status

Enrolling

Conditions

Total Hip Arthroplasty

Treatments

Other: Conventional rehabilitation
Device: Virtual Reality Rehabilitation System (VRRS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05173480
AziendaU9S

Details and patient eligibility

About

This study aims to assess the efficacy of virtual reality through the Virtual Reality Rehabilitation System (VRRS) added to conventional rehabilitation versus conventional rehabilitation alone, for improving mobility, balance, and walking assessed by Timed Up and Go after primary Total Hip Arthroplasty.

Full description

Following ethics approval by the ULSS 9, adults with THA (at 7 days after surgery), aged between 45 and 85 years old will be recruited for the study by the office worker of the rehabilitation hospital. Patients will be informed about the aim of the study and will sign the informed consent. Patients that decided to participate in the study will be randomized into two rehabilitation groups: experimental group and control group. Patients will be evaluated for reaching the baseline data from a physiotherapist blind to the aim of the study. Both groups (experimental and control) will receive the same clinical indications during hospitalization. Both groups will perform the same daily warm-up exercises supervised by physiotherapists external to the study investigation and will receive the same conventional-exercises program. In addition to this, each group will perform a second rehabilitation session with the virtual reality, using the Virtual Reality Rehabilitation System (VRRS), but in the control group, the sensors of VRRS will be not connected. The primary outcome will be the Timed Up and Go (TUG), the test used to assess mobility, balance, and walking.

Enrollment

75 estimated patients

Sex

All

Ages

45 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age: 45-85 years
  • primary unilateral THA for hip osteoarthritis
  • signed informed consent

Exclusion criteria

  • people with clinically unstable serious diseases (e.g., heart or lung disease)
  • secondary THA replacement on the same side
  • hip replacement for neoplasm, proximal femoral fracture, or other causes out of osteoarthritis
  • contemporary bilateral replacement
  • cancer
  • presence of neurological diseases previous or following surgery
  • congenital abnormalities
  • patients with THA infection
  • diabetes
  • psychotropic drugs assumption for pain management

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

75 participants in 2 patient groups

Experimental group
Experimental group
Description:
VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation.
Treatment:
Other: Conventional rehabilitation
Device: Virtual Reality Rehabilitation System (VRRS)
Device: Virtual Reality Rehabilitation System (VRRS)
Control group
Active Comparator group
Description:
VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation.
Treatment:
Other: Conventional rehabilitation
Device: Virtual Reality Rehabilitation System (VRRS)
Device: Virtual Reality Rehabilitation System (VRRS)

Trial contacts and locations

1

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Central trial contact

Mauro Crestani

Data sourced from clinicaltrials.gov

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