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effects of functional virtual reality intervention on biomechanic indexes and proprioception 6 month after high tibial osteotomy operation

Protocol summary

Study aim
Determining the effect of virtual reality intervention on biomechanical indices and proprioception in individuals after proximal tibial osteotomy surgery
Design
Clinical trial on 28 samples, with two groups: intervention and control, double-blind and randomized with categorized block method
Settings and conduct
Interventions are conducted at the Red Crescent Comprehensive Rehabilitation Center, with 12 sessions of 45 minutes each per person, three days a week. The participants and the trained occupational therapist are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 30-50 years who have undergone unilateral proximal tibial osteotomy surgery, at least 3 months to 1-year post-surgery, completion of a written and informed consent form. Exclusion criteria: Any neurological or neuromuscular disorder that affects balance, use of medications that impair balance, presence of cognitive or psychological disorders, presence of infection or open wounds in the studied limb, patient's withdrawal from the study.
Intervention groups
In the intervention group, routine rehabilitation interventions, along with virtual reality exercises aimed at increasing balance, proprioception, and postural stability, designed and programmed by the researcher and executed using a virtual reality device, are also performed for 45 minutes. In the control group, patients receive routine rehabilitation exercises along with balance and proprioception exercises with similar repetition and intensity for 45 minutes under the supervision of a trained occupational therapist.
Main outcome variables
Quality of life score, Static and Dynamic balance, and proprioception after 4 weeks of intervention in intervention and control groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250903067109N1
Registration date: 2026-01-31, 1404/11/11
Registration timing: prospective

Last update: 2026-01-31, 1404/11/11
Update count: 0
Registration date
2026-01-31, 1404/11/11
Registrant information
Name
Reyhane Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 728 7175
Email address
reyhane.zare@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of functional virtual reality intervention on biomechanic indexes and proprioception 6 month after high tibial osteotomy operation
Public title
effects of functional virtual reality intervention on biomechanic indexes and proprioception after high tibial osteotomy operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Performing proximal tibial osteotomy surgery for the first time unilateral surgery homogenity of groups in terms of surgical method and the time elapsed since surgery Patients should be in the age range of 30-50 years Willingness to participate in research and understand information related to the research content ability to answer the questions in persian Cognitively, being in the 24-30 range based on the MMSE scale Ability to walk and maintain balance while standing without any assistive device At least 3 months and at most one year should have passed since the surgery. No complications after surgery, such as non-union, delayed union, and infection No neurological problems No accompanying neurological diseases or other orthopedic disorders that impair balance. Avoid using balance-disrupting medications during the assessment and intervention period No other surgery on the lower limb in the past year
Exclusion criteria:
Damage to the operated bone such that a second surgery is required. The presence of issues such as embolism that have disrupted the normal course of treatment Unwillingness to continue cooperation
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
More than 1 sample in each individual
Number of samples in each individual: 1
Each person provides one sample
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a stratified block randomization method will be used. Participants will first be stratified based on their Body Mass Index (BMI) to control for its potential confounding effect on the study outcomes. Within each BMI stratum, randomization will be performed using block of four to ensure balanced allocation between the intervention and control groups. The allocation sequences within each block will be randomly generated using Random Allocation Software, with a fixed block size of 4. The randomization and allocation process will be conducted by an independent researcher who is not involved in date collection or intervention implementation.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind design. In this trial, both the participants and the outcome assessors will be blinded to the type of intervention received. Allocation to the intervention and control groups will be performed using coded randomization, and each participant will receive a unique identification code. The intervention will be prepared or presented in identical forms to prevent any visual or procedural differences between groups. The allocation codes will remain concealed from the principal investigator and data analyst until the completion of data analysis and will only be disclosed in case of serious adverse events requiring unblinding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor in research afairs- Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti university of medical Science, arabi St., Daneshjoo Blvd., velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-11-10, 1403/08/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.444

Health conditions studied

1

Description of health condition studied
post-operative rehabilitation of patients with high tibial osteotomy.
ICD-10 code
M21.16
ICD-10 code description
Varus deformity, not elsewhere classified, knee

Primary outcomes

1

Description
Static balance
Timepoint
The begining of the study before intervention and 4 weeks after using the intervention
Method of measurement
force plate

2

Description
Dynamic balance
Timepoint
The begining of the study before intervention and 4 weeks after using the intervention
Method of measurement
STAR test

3

Description
Quality of life
Timepoint
The begining of the study before intervention and 4 weeks after using the intervention
Method of measurement
Knee injury and Osteoarthritis Outcome Score questionaire (KOOS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will perform routine rehabilitation interventions in addition to virtual reality exercises aimed at improving balance, proprioception, and postural stability, which are designed and programmed by the researcher and executed using a virtual reality device, for 4 weeks, with 3 sessions of 45 minutes each per week. In this group, in addition to routine balance rehabilitation interventions, interventions using the SENA intelligent rehabilitation system at the Red Crescent Comprehensive Rehabilitation Center and the related device will also be carried out. The Kinect camera of this tool determines the patient's joint angles and presents them as an avatar on the screen, providing various dynamic balance exercises. Using the balance board, which is connected to the device via a cable, also enables static balance exercises. During the exercises, a target is usually set for the patient, represented by colored balls, and the patient hits the targets by moving their feet or shifting their center of gravity. The size of the target, the time to reach it, and the number of hits can change the level of the games and determine the difficulty of the exercises according to the therapist's judgment and the patient's progress. Additionally, during the exercises, appropriate auditory and visual feedback is provided through the display based on the individual's performance.
Category
Rehabilitation

2

Description
Control group: In the control group, patients receive routine rehabilitation exercises in addition to balance and proprioception exercises such as standing and walking on uneven surfaces, postural stability exercises, and gait training exercises with similar repetition and intensity for 4 weeks, three 45-minute sessions per week under the supervision of a trained occupational therapist. Routine rehabilitation includes full weight bearing on the affected knee, strengthening the muscles around the knees, especially the vastus medialis and quadriceps, lateral and forward step-up exercises, weight transfer exercises from one leg to the other using a foam roll and balance board, walking on the foam roll, and other uneven surfaces.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Biomechanics Laboratory, Faculty of Rehabilitation, Shahid Beheshti University
Full name of responsible person
Reyhane Zare
Street address
biomechanics laboratory, Shahid Beheshti Faculty of Rehabilitation Sciences, in front of Bu Ali hospital, Damavand St. , Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 2243 9907
Fax
Email
pcu@sbmu.ac.ir
Web page address
https://isid.research.ac.ir/Afshin_Zarghi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhane Zare
Position
Occupational therapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Beheshti Faculty of Rehabilitation Science, in front of Bu Ali hospital, Damavand street
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Fax
Email
reyhane.zare@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhane Zare
Position
Occupational therapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Beheshti Faculty of Rehabilitation Science, in front of Bu Ali hospital, Damavand street
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
reyhane.zare@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhane Zare
Position
Occupational therapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Beheshti Faculty of Rehabilitation Science, in front of Bu Ali hospital, Damavand street
City
tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
reyhane.zare@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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