Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
Design
Due to the importance of homogenization of the two groups of control and intervention, a randomized randomization method is used in which elimination of possible heterogeneity by classification is performed on the variables of the disease grade prior to random allocation. A clinical trial Blind two-way, calculation of sample size based on the formula and by conducting pilot studies.
Settings and conduct
Initial and pre-test measurements in the physiotherapy center of Imam Ali Hospital in Bojnourd, provide training and advice on how to conduct resistance exercises correctly through the application within 2 months randomly and without knowledge of the participants and evaluators. Patients will be treated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Satisfaction to do research،Radiological signs of knee osteoarthritis with the approval of a physician،Age 40-70 years،The patient and patient accompanying the smartphone should be available،Have the ability to use the mobile app،Exclusion criteria:Patients who have to undergo a knee surgery during the study،Use intra-articular intravenous medications during the study،During the study, they will develop mental illness،Underlying illness (such as diabetes, ...)،They are reluctant to continue to participate in the study
Intervention groups
Intervention group:Patients with knee osteoarthritis who receive the application will receive training and advice for the correct performance of the exercise through the app within 2 months.Control group:Patients with knee osteoarthritis who, according to the routine, are trained and advised to improve their quality of life.
Main outcome variables
Knee pain in women with knee osteoarthritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161208031300N2
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2019-04-06, 1398/01/17
Update count:1
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Reza Ganji
Name of organization / entity
North Khorasan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7010
Email address
r.ganji@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
Public title
Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to do research
Radiological symptoms of knee osteoarthritis with the approval of a physician
The age range is between 40-70 years
The smartphone itself is the patient or companion patient that is always available to the patient
Ability to use the mobile app
Exclusion criteria:
Patients who undergo surgery on their knees.
use intra-articular injectable drugs
they will develop mental illness
Underlying illness (such as diabetes, ...)
Failure to follow up
Age
From 40 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
A random assignment sequence has been created, each row of sequences placed inside a pre-waxed envelope, and then the envelopes are arranged in the box, and the patients removed one of the envelopes and then opened the envelope scholar. And doing the study according to the group in which the person is located.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind, a researcher who collects information about the performance and quality of life of patients, is not aware of the presence of any patient in the intervention group or group comparison.Also, in order to prevent the patients from moving between groups, after the patients were randomly assigned to the intervention and intervention group, they will be asked to request intervention from the patients in the couple's days and the patients in the comparison group on the following days. The clinic is to prevent patients from speaking in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی خراسان شمالی
Street address
Bojnourd - Shahriar Avenue - above Imam Ali Hospital (AS) - Faculty of Medicine - Deputy of Research and Technology University
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
ir.nkums.rec.1397.085
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Knee pain
Timepoint
24 hours before the intervention and 24 hours after the intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes
1
Description
improving the quality of life
Timepoint
24 hours before the intervention and 24 hours after the intervention
Method of measurement
Health Assessment Questionnaire
Intervention groups
1
Description
Intervention group:Patients with knee osteoarthritis who receive the application will receive training and advice for the correct performance of the exercise through the app within 2 months.
Category
Treatment - Devices
2
Description
Control group:Patients with knee osteoarthritis who, according to the routine, are trained and advised to improve their quality of life.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Specialized Clinic
Full name of responsible person
Reza Ganji
Street address
Shahriar Avenue - next to Imam Ali Hospital
City
Bojnurd
Province
North Khorasan
Postal code
94176914735
Phone
+98 58 3229 6966
Email
r.ganji@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
reza ganji
Street address
Shahriar Ave. above Imam Ali Hospital - Faculty of Medicine - Deputy of Research and Technology University
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7182
Email
r.ganji@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
seyed sajad arfaei chitgar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti St. 12, 9th
City
Quchan
Province
Razavi Khorasan
Postal code
9471894397
Phone
+98 51 4722 9724
Email
seyedsajad.arfaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
reza ganji
Position
Assistant Professor, Faculty Member of North Khorasan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahriar Ave. above Imam Ali Hospital - Faculty of Medicine - Deputy of Research and Technology University
City
Bojnurd
Province
North Khorasan
Postal code
94176914735
Phone
+98 58 3229 7182
Email
r.ganji@nkums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
reza ganji
Position
Assistant Professor, Faculty Member of North Khorasan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahriar Ave. above Imam Ali Hospital - Faculty of Medicine - Deputy of Research and Technology University
City
Bojnurd
Province
North Khorasan
Postal code
94176914735
Phone
+98 58 3229 7182
Fax
Email
r.ganji@nkums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome of this study will be shared through the article.
When the data will become available and for how long
The start of the access period will be 6 month after the results are printed.
To whom data/document is available
For researchers working in academic and scientific institutions and those engaged in the industry, they can apply for them.
Under which criteria data/document could be used
Terms of use of data or documentation: 1. Failure to remove or modify the original address of the authors of scientific articles 2. Present actual research results 3. Having specialized knowledge and academic competence in the research subject 4. Observe the interests of stakeholders at all stages 5. No publication of the results of the plan without coordination and obtaining a license