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

Total Hip Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173480
• Other study ID #: AziendaU9S
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2023
• Source: Azienda Ulss 9 Scaligera
• Contact: Mauro Crestani
• Phone: 3381479872
• Email: mauro.crestani.93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Other:
• Conventional rehabilitation
Exercise therapy through conventional rehabilitation training made by physiotherapists.

Device:
• Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through a virtual reality rehabilitation system (VRRS).
• Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.

Locations

Country	Name	City	State
Italy	AULSS 9 - Marzana Hospital	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Mauro Crestani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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.	baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)