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the effect of adding virtual reality- based rehabilitation to conventional physiotherapy on functional level,pain and balance in patients after total knee arthroplasty

Protocol summary

Study aim
The effect of adding virtual reality-based rehabilitation to conventional physiotherapy on functional level, pain and balance in patients after total knee arthroplasty
Design
The study is two arm parallel randomized trial with blinded,outcome assessor , on 40 patients after knee joint replacement surgery. randomization will be used by Block randomization method.
Settings and conduct
patients after total knee joint replacement in Erfan, Sina and Nikan hospitals referred to Sabay Salamat Physiotherapy Center in 1402. The patients were randomly divided into intervention and control groups.control group will receive standard physiotherapy after knee replacement surgery and intervention group , will receive , virtual reality based exercises . this study, is outcome assessor blind,the implementation and evaluation method is designed to blind the evaluator, so the therapist will be different from the evaluator
Participants/Inclusion and exclusion criteria
Patients are eligible for inclusion and exclusion criteria if a total knee replacement after idiopathic,post traumatic osteoarthritis was implemented.The criteria s include age between 45-65 years,Body Mass Index lesser than 31, Ability to weight bearing on affected limb,Absence of redicular pain, cognitive disorders,imbalance and previous history of surgery in affected limb.
Intervention groups
Each patient will allocate to an experimental(VR; virtual reality group) or to a control group. The control group will receive standard physiotherapy after joint replacement, including modalities that reduce pain and inflammation, joint replacement exercises according to the knee joint replacement rehabilitation guidelines, such as range of motion and strength exercises , the control group will receive therapeutic exercises with virtual reality .
Main outcome variables
Womac questionnaire,VAS scale,static and dynamic balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230524058283N1
Registration date: 2023-08-10, 1402/05/19
Registration timing: prospective

Last update: 2023-08-10, 1402/05/19
Update count: 0
Registration date
2023-08-10, 1402/05/19
Registrant information
Name
Ghazal Hashemi Zenooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4428 3829
Email address
hashemi.ghz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-07, 1402/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of adding virtual reality- based rehabilitation to conventional physiotherapy on functional level,pain and balance in patients after total knee arthroplasty
Public title
the effect of adding virtual reality- based rehabilitation to conventional physiotherapy on functional level,pain and balance in patients after total knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45-65years Ability to weight bearing on affected limb To 7 days after surgery Body mass index lower than 31 Total knee arthroplasty with primary diagnosis of osteoarthrosis
Exclusion criteria:
1-history of previous surgery in operated leg for instant tibial osteotomy or fixation 2-history of former total knee or hip arthroplasty 3-neurologic or cognitive disorders that affect patients walking ability 4-diziness and vestibular disorders that affect patients balance 5-having joint infections,amboly and prosthesis loosening 6-painfull contra-lateral knee joint arthrosis 7-visual dysfunctions 8-problems that disturb patients corporation with virtual environment for instant demance,psychological disorders and ...
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Block method was used for randomization in the present study.we will choose 10 blocks of 4 patients. Randomization Block method has been designed to randomize the distribution of people into the studied groups in such a way that the sample size of the groups is equal. 10 blocks of 4 patients were selected. In each block, an equal number of people was assigned to each group. 10 blocks, were determined, and then blocks of both intervention and control groups were randomized. For example, when a participant entered the study, he was asked to select a block from blocks 1 to 10 and then either A or B. After block selection, the order of the other three subjects was determined randomly.then the information will deliver to secreter in closed envelopes
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comitee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2023-05-10, 1402/02/20
Ethics committee reference number
IR.USWR.REC.1402.024

Health conditions studied

1

Description of health condition studied
total knee arthroplasty
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Patient functional level with Western Ontario and McMaster universities Osteoarthritis index(WOMAC)
Timepoint
After and before treatment,1 month after treatment
Method of measurement
Western Ontario and McMaster universities Osteoarthritis index(WOMAC) questionnaire

Secondary outcomes

1

Description
Pain
Timepoint
Before and after treatment
Method of measurement
Visual Analogue Scale

2

Description
Static balance
Timepoint
Before and after treatment
Method of measurement
Body center of pressure displacement and velocity parameters in standing position

3

Description
dynamic balance
Timepoint
before and after treatment
Method of measurement
functional reach test

Intervention groups

1

Description
"Intervention group": virtual reality based rehabilitation by Kinect.Patients will do their exercises in front of Kinect's Infra Red cameras from 5th to 10th session with duration of 20 minutes.This technology provides real time visual feedback during exercises.
Category
Rehabilitation

2

Description
"Control group": Patients will be treated with standard physiotherapy after total knee arthroplasty surgery that include different modalities for reducing pain and inflammation and doing exercises in all sessions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Saba Salamat Physiotherapy
Full name of responsible person
Ghazal Hashemi Zenooz
Street address
No. 10, 1st. Alborz Alley, Alborz St., Marzdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1463864463
Phone
+98 21 4480 1802
Email
hashemi.ghz@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra mosallanezhad
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0109
Email
webmaster@uswr.ac.ir
Web page address
https://www.uswr.ac.ir/
Grant name
---
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
zahra mosallanezhad
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
dakyar Ave., daneshjo Blvd.,Evin
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2833
Email
webmaster@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
zahra mosalla nezhad
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
zmosallanezhad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ghazal Hashemi Zenooz
Position
Physiotherapyst
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
number 34,sepehr7 alli,sepehr street,marzdaran blvd
City
Tehran
Province
Tehran
Postal code
1463815141
Phone
44801802
Email
hashemi.ghz@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
patients privacy
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
No - There is not 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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