Developing a machine-based training program for using Wii Fit to evaluate patient's balance and physical function after anterior cruciate ligament reconstruction
The overall objective of this study was to develop a machine-based training program using the Nintendo Wii Fit to evaluate the balance and physical performance of patients after reconstructing the anterior cruciate ligament.
Design
In this study,20 subjects after random allocation in two groups will be treated in parallel. First, a summary of the research program is presented for them, then the checklist of the research, which includes questions about demographic information and the medical history is completed. Then, other clinical, functional and balance evaluations will be performed
Settings and conduct
This study will be performed on patients after ACL reconstruction surgery at the physical therapy clinic, Tarbiat Modares University.
Participants/Inclusion and exclusion criteria
Male patients aged between 20-30 years who at least 3 months have passed since their ACL reconstruction surgery without any chronic diseases and injuries that affect the study.
Intervention groups
1-Wii Fit System Machine Based Rehabilitation Group ;
2-Conventional Exercise Therapy Group ;
Main outcome variables
Pain; Active knee flexion range of motion; The circumference of the thigh; Physical Function;Static & Dynamic Balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045090N1
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Arezoo Abasi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8788 8828
Email address
arezoo_abasi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing a machine-based training program for using Wii Fit to evaluate patient's balance and physical function after anterior cruciate ligament reconstruction
Public title
Developing a machine-based training program in rehabilitation after reconstruction of the anterior cruciate ligament
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral ACL injury with specialist physician diagnosis and MRI approval
At least 3 months after ACL reconstruction surgery (With Bone-Patellar-Tendon-Bone Surgery Type)
Male
Full consent to participate in the research
Having a referral from an orthopedic specialist
Complete cardiovascular health of patients with physician approval
Balanced state of mind
Exclusion criteria:
Unfinished treatment programs and assessment
The occurrence of any sudden systemic disorder during rehabilitation according to the patient
The patient's willingness to withdraw from the study and unfinished treatment
Performing exercises outside the prescribed schedule according to the patient
Receive any treatment other than the treatment plans prescribed in this research plan
Injury to other ligaments and knee joint structures with orthopedic specialist approval
Previous surgery or injury in the knee of the opposite side and other joints of the lower extremities with orthopedic specialist approval
Taking painkillers, anti-inflammatory drugs, etc
Chronic illness or other known condition that may affect research research
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The study samples will be divided into study groups (Interfering with Wii Fit, treatment with conventional therapy) by a quadruple-block random sampling among eligible patients undergoing ACL reconstruction.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator of research outcomes will be blinded to treatment groups.
The person who does the statistical analysis of the data will also be blind to the treatment modalities and treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Al ahmad Street, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.MODARES.REC.1398.124
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament tear
ICD-10 code
ICD-10 code description
Sprain of anterior cruciate ligament of knee
Primary outcomes
1
Description
Static Balance
Timepoint
Pre and Post Intervention
Method of measurement
Balance Error Scoring System Test
2
Description
Dynamic Balance
Timepoint
Pre and Post Intervention
Method of measurement
Modified Star Excursion Balance Test
3
Description
Physical Function
Timepoint
Pre and Post Intervention
Method of measurement
Single leg hop for time & One leg hop for distance
Secondary outcomes
1
Description
Pain Intensity
Timepoint
Pre and Post Intervention
Method of measurement
Visual Analogue Scale
2
Description
Knee range of motion
Timepoint
Pre and Post Intervention
Method of measurement
Goniometery
3
Description
Thigh Atrophy
Timepoint
Pre and Post Intervention
Method of measurement
Measurement of thigh circumference with Cm tape measure
Intervention groups
1
Description
Intervention group: ]It is a game-based rehabilitation program based on expert opinions and with the Wii Fit system to improve the balance for patients after reconstruction of the anterior cruciate ligament and Includes seven Ski Slalom, Ski Jump, Table Tilt, Balance Bubble, Perfect 10, Penguin Slide, Skateboard Adena on Wii system.
Category
Rehabilitation
2
Description
Control group: The common rehabilitation program treatments used in physiotherapy clinics for patients after reconstruction of the anterior cruciate ligament.Patients' exercise therapy programs in the control group will include:• Static exercises for quadriceps, hamstring, gluteal muscles and SLR. .•Closed chain exercises to increase knee mobility.• Proprioseptive exercises on the balance board.• Functional exercises such as using a stationary bike or treadmill.• Stretching exercises for the lower extremities .• Lower extremity muscle strengthening exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physiotherapy - Tarbiat Modares University
Full name of responsible person
Anoshirvan Kazemnejad lili
Street address
Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
pres@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Anoshirvan Kazemnejad lili
Street address
Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3875
Email
kazem_an@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
10
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
Tarbiat Modares University
Full name of responsible person
Arezoo Abasi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3875
Email
arezoo_abasi@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Arezoo Abasi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3875
Email
arezoo_abasi@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Arezoo Abasi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3875
Email
arezoo_abasi@modares.ac.ir
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
Due to ethical standards, The participants have been promised that the information of this research will remain confidential in their written consent form.
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Part of the data, such as information about the main outcomeس can be shared.
When the data will become available and for how long
One year after the publication of articles related to the research project
To whom data/document is available
The researchers and specialists working in universities and health centers
Under which criteria data/document could be used
Analysis of the data delivered after obtaining permission from the researchers
From where data/document is obtainable
Arezoo Abasi Medical Informatics Dept., Faculty of Medicine,Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran, Postal code 14115-111
What processes are involved for a request to access data/document
The applicant of the data file should send a request to the researcher via an email and the researcher will inform the applicant after negotiating with other research colleagues, and this process will take a maximum of one month.