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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation. |
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| Control group | Active Comparator | VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional rehabilitation | Other | Exercise therapy through conventional rehabilitation training made by physiotherapists. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (7 days after surgery) and at discharge (28 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauro Crestani | Contact | 3381479872 | mauro.crestani.93@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mauro Crestani | Azienda Ulss 9 Scaligera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AULSS 9 - Marzana Hospital | Recruiting | Verona | 37142 | Italy |
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| Virtual Reality Rehabilitation System (VRRS) | Device | Exercise therapy through a virtual reality rehabilitation system (VRRS). |
|
| Virtual Reality Rehabilitation System (VRRS) | Device | Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected. |
|
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. |
| 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) | 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 | 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 | 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) | 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 | 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 | assessed and reported at discharge (28 days after surgery) |