Effect of 6-week strength-balance training under virtual reality environment on the co-contraction of lower limb muscles and center of pressure sway during limit of stability, curve tracking and turning in women with primary osteoporosis
Effect of 6-week strength-balance training under virtual reality environment on the co-contraction of lower limb muscles and center of pressure sway during limit of stability, curve tracking and turning in women with primary osteoporosis
Design
Clinical trial with intervention and control groups, parallel group, double-blind, randomized groups using random number table
Settings and conduct
The study will be conducted at Tarbiat Modares University's Gait Lab on women with primary osteoporosis. Intervention group will perform 6-weeks of strength-balance training using active video games via the Xbox 360 Kinect. control group will also perform 6 weeks of specific strength-balance training using the pulley and tilt board. In both groups, the effects of training on lower extremity muscle cocontraction and center of pressure sway after treatment will be examined.Individuals in each study groups were not aware of the type of exercise in the other group.
The assessor is also blind to the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria؛ Women with primary osteoporosis after menopause
Age range 48-65
At least one year has passed since the onset of menopause
Not participating in regular exercise
Obtain the normal score from the Mini mental exam Questionnaire
Exclusion criteria؛ Vision problems
A history of osteoporosis fractures
Balance problems such as sudden falls
Secondary osteoporosis
Intervention groups
Intervention group: 6 weeks strength-balance training under virtual reality environment
Control group: 6 weeks of dedicated, lightweight strength-balance training using Polley and Tilt Board
Main outcome variables
Muscle strength; quality of life and fear of falling score؛ RMS؛ Coactivation index؛ LOS(reaction time)؛ Curve tracking(RMS error)؛Curve tracking(area)؛
Curve tracking(mean frequency)؛ Curve tracking(peak frequency)؛ Turning (turning sway)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101017004952N9
Registration date:2019-11-30, 1398/09/09
Registration timing:registered_while_recruiting
Last update:2019-11-30, 1398/09/09
Update count:0
Registration date
2019-11-30, 1398/09/09
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
2019-10-22, 1398/07/30
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 6-week strength-balance training under virtual reality environment on the co-contraction of lower limb muscles and center of pressure sway during limit of stability, curve tracking and turning in women with primary osteoporosis
Public title
Effect of training under virtual reality environment on the co-contraction of lower limb muscles and center of pressure sway
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI 22-30 kg / m 2
At least one year after menopause
Not participating in regular exercise
Not being on hormone therapy for at least the past 6 months
No musculoskeletal and neurological problems
Obtain the normal score from the Mini mental state exam
Age range 48-65
Exclusion criteria:
Balance problems such as sudden falls
A history of osteoporotic fractures
Vision problems
Use of walking aids
Age
From 48 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by an independent person by blocking randomization using sealed, opaque, and stapled envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in each group are not aware of the other group program. The assessor or data collector is blinded about grouping.
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
Jalale ale ahmad., nasr bridge., chamran highway
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
IR.MODARES.REC.1398.151
Health conditions studied
1
Description of health condition studied
postmenopausal osteoporosis
ICD-10 code
m81.9
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
ٍEMG and Co-contracting index of muscles in functional activities
Timepoint
The timing of measurements will be before the start of the intervention and after 6 weeks of strength-balance training.
Method of measurement
Electromyography system
2
Description
CoP sway in functional activities
Timepoint
The timing of measurements will be before the start of the intervention and after 6 weeks of strength-balance training.
Method of measurement
mars software and force plate
Secondary outcomes
1
Description
Quality of Life Score
Timepoint
The variables will be measured at baseline and also after 6 weeks of strength-balance training.
Method of measurement
Qualeffo-41 Questionnaire, Fall Efficacy Scale Questionnaire
2
Description
Muscle strength
Timepoint
The variables will be measured at baseline and also after 6 weeks of strength-balance training.
Method of measurement
Digital hand-held dynamometer
Intervention groups
1
Description
Intervention group: 6 weeks of 3 sessions of strength-balance training under virtual reality environments through active video games using the Xbox kinect 360 Console
Category
Rehabilitation
2
Description
Control group: Performing specific, lightweight strength-balance training for 3 days a week for 6 weeks using a pulley and tilt board