Clinical trial NCT05173480: Does Virtual Reality Rehabilitation Improve Mobility, Balance, and Walking in Patients With Total Hip Arthroplasty?
Official title: Does Virtual Reality Rehabilitation Added to Conventional Physiotherapy Improve Mobility, Balance, and Walking Assessed by Timed Up and Go in Patients With Total Hip Arthroplasty? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Virtual reality rehabilitation
Physiotherapy
Physical therapy
Lead sponsor: Azienda Ulss 9 Scaligera
Sponsor class: OTHER_GOV
First posted: 2021-12-30
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Timed Up and Go (TUG) score
timeFrame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Secondary outcomes:
measure: Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
timeFrame: baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview)
measure: Change in the Numeric Rating Scale for pain (NPRS)
timeFrame: baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
measure: Change in the Hip Active Range of Motion
timeFrame: baseline (7 days after surgery) and at discharge (28 days after surgery)
measure: Change in the Strength of main muscles of the pelvis and thigh of the affected limb
timeFrame: baseline (7 days after surgery) and at discharge (28 days after surgery)
measure: Change in the 6 Minutes Walking Test (6MWT)
timeFrame: baseline (7 days after surgery) and at discharge (28 days after surgery)
measure: Change in the Short Form Health Survey 36 (SF-36)
timeFrame: baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview)
measure: Change in the Numeric Rating of Patient Satisfaction with functional outcome
timeFrame: assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview)
measure: The drugs assumption for pain management
timeFrame: assessed and reported at discharge (28 days after surgery)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AULSS 9 - Marzana Hospital
Study officials:
affiliation: Azienda Ulss 9 Scaligera
name: Mauro Crestani
role: PRINCIPAL_INVESTIGATOR
References: