The comparison of the conventional versus virtual reality training on the functional movement skills in women with primary osteoporosis
Design
Clinical trials include control group, conventional training group and exergame group, double blind and randomized trials with blinded postoperative outcome assessment and evaluator
Settings and conduct
individuals are randomly divided into three groups, before and after the intervention, the motion control indicators will be checked with the help of the Mars software of Kistler force platform and the motion analyser ( Vicon)device.The outcome analyst and data analyst are unaware of how the group is intercepted and grouped
Participants/Inclusion and exclusion criteria
تقاضای بیمار برای ادامه ندادن درمان به هر دلیل و شرکت نکردن منظم در برنامه
Intervention groups
1-conventional training group 2-exergame group 3-control group
Main outcome variables
The center of pressure variable, which is obtained in limits of stability , curve tracking, sit to stand test, turning by the Mars software and with the aid of the force plate, and analyzing the torque around the lower limb joints of the dominant foot by the motion analysis camera
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101017004952N7
Registration date:2019-04-21, 1398/02/01
Registration timing:registered_while_recruiting
Last update:2019-04-21, 1398/02/01
Update count:0
Registration date
2019-04-21, 1398/02/01
Registrant information
Name
Giti Torkaman
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
torkamg@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the conventional versus virtual reality training on the functional movement skills in women with primary osteoporosis.
Public title
Effect of exercise therapy on quality of functional movement skills in primary osteoporosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI: 22-30 kg/m*m
Have at least one year of menopause
Not attending sports regularly, at least a year before the start of the study(At least 30 minutes a day and 2 to 3 days a week)
Cardiologist and rheumatologist confirm their entry into the power-balance exercise protocol
Eating the same dose of calcium and vitamin D based on the prescription of rheumatologist
According to the WHO criteria, bone mineral density (BMD) pre-entry bone mass for menopausal osteoporotic meningitis was 2.5-> Tscore and for non-osteoporotic menopause subjects Tscore> -1.5
There is no history of fractures due to osteoporosis
There is no secondary osteoporosis
Do not suffer from cardiovascular disease and diseases of the joints of the extrimities and spine
Do not take medications that affect the level of consciousness, such as sedation
no hormone therapy for at least 6 months
Exclusion criteria:
Patient's request to discontinue treatment for any reason and not to participate in the program regularly.
Age
From 48 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
people allocated with simple randomization method via random numbers and divided into three groups: exergame group, traditional exercise group, control group
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst are biomechanics who are unaware of who is involved in each group. The data is recorded by the machine, without any knowledge of the type of training.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Biomedical Research of Tarbiat Modares University
Street address
Jalal AleAhmad Ave., Nasr
City
tehran
Province
Tehran
Postal code
1411713116
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.MODARES.REC.1397.050
Health conditions studied
1
Description of health condition studied
postmenopausal osteporosis
ICD-10 code
m81.9
ICD-10 code description
osteoporosis, unspecified
Primary outcomes
1
Description
Cop sway velocity and displacement in functional activity testes, sit to stand, limit of stability, reaching and curve tracking
Timepoint
pre and post intervention
Method of measurement
motion analyser, kistler forceplate and Mars software
Secondary outcomes
1
Description
activity balance - specific questionnaire
Timepoint
pre and post intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group 1: conventional training group
Category
Rehabilitation
2
Description
Intervention group 2: exergame
Category
Rehabilitation
3
Description
Control group: maintaining physical activity and activity of daily living as same as entrance time.