An interventional study of Conventional rehabilitation and Virtual Reality Rehabilitation System (VRRS) in Total Hip Arthroplasty, sponsored by Mauro Crestani. Status unknown at 1 site in Italy. Open to participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by Mauro Crestani · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Mauro Crestani as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation.
Other: Conventional rehabilitation · Device: Virtual Reality Rehabilitation System (VRRS)
VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation.
Other: Conventional rehabilitation · Device: Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through conventional rehabilitation training made by physiotherapists.
Exercise therapy through a virtual reality rehabilitation system (VRRS).
Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.
Change in the Timed Up and Go (TUG) score
The TUG is a timed test used to assess mobility, balance, and walking. The subject must stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
The HOOS scale scores range from 0 to 100 (0: total hip disability, 100: perfect hip health)
Time frame: baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview)
Change in the Numeric Rating Scale for pain (NPRS)
A 10-cm Numerical Pain Rating Scale (0: no pain, 10: maximum pain) will be used to assess the current level of hip pain before rehabilitation treatment.
Time frame: baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
Change in the Hip Active Range of Motion
Assessed by goniometer (degree of movement)
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Strength of main muscles of the pelvis and thigh of the affected limb
Assessed by dynamometer
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the 6 Minutes Walking Test (6MWT)
Walking ability and cardio-respiratory function
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Short Form Health Survey 36 (SF-36)
Short Form Health Survey scores range from 0 to 100 (0: maximum disability; 100: no disability)
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview)
Change in the Numeric Rating of Patient Satisfaction with functional outcome
A 10-cm Numeric Rating of Patient Satisfaction with the functional outcome (0: no satisfaction; 10: maximum satisfaction) is used to assess the general satisfaction of the patients
Time frame: assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview)
The drugs assumption for pain management
Type of drugs intake for each group during rehabilitation recovery
Time frame: assessed and reported at discharge (28 days after surgery)
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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