The purpose of this study is the effect of sensorimotor training with visual feedback on proprioception and alignment of joint in woman with dynamic knee valgus
Design
Single-blind randomized clinical trial with control group (n=40)
Settings and conduct
The present quasi-experimental study is performed in the rehabilitation laboratory of arak university. The experimental group performs sensorimotor training for 8 week, 3sessions per week and each session lasts 45-60 minutes. Static and dynamic balance, proprioception, range of motion of hip and knee, knee joint alignment respectively, with the y test and walking the single leg squat test (sls( ,goniometer and also the single-leg landing test.
Participants/Inclusion and exclusion criteria
Inclusion criteria : female gender, age range 18-30 years, no history of knee surgery, no injury to the lower limb in the last year, and subjects suffering from dynamic knee valgus.
Exclusion criteria: neurological and orthopedic problems, special diseases
Intervention groups
Intervention group: the participants in this group perform sensorimotor training for 8 weeks, 3 sessions per week and each session lasts 45-60 minutes.
Control group: they will have the usual routine of their lives.
Main outcome variables
Static and dynamic balance, proprioception, alignment of knee joint, hip and knee range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N12
Registration date:2023-06-07, 1402/03/17
Registration timing:registered_while_recruiting
Last update:2023-06-07, 1402/03/17
Update count:0
Registration date
2023-06-07, 1402/03/17
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sensorimotor training with visual feedback on proprioception and alignment of joint in woman with dynamic knee valgus
Public title
Sensorimotor training with visual feedback on proprioception and alignment of joint in woman with dynamic knee valgus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
Age 18 to 30 years
No history of knee surgery
No injury to the lower limb in the last year
Subjects suffering from dynamic knee valgus
Exclusion criteria:
Neurological and orthopedic problems
Suffering from any disease affecting the study variables
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is parallel. The randomization unit is individual. The Randlist software is used to assign subjects to study groups randomly. At, the number of participants and groups is given to the software. Then, with this software, each participant is assigned a code. A group is then randomly assigned to each code by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not be aware of the group's classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, and for each participant with a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.ARAKU.REC.1402.008
Health conditions studied
1
Description of health condition studied
dynamic knee valgus
ICD-10 code
M21.06
ICD-10 code description
Valgus deformity, not elsewhere classified, knee
Primary outcomes
1
Description
Alignment of joint
Timepoint
Before and after 8 week intervention
Method of measurement
Single leg landing test
2
Description
Proprioception
Timepoint
Before and after 8 week intervention
Method of measurement
Single leg squat (sls) and photogrammetry
3
Description
Hip and knee range of motion
Timepoint
Before and after 8 week intervention
Method of measurement
Goniometer
Secondary outcomes
1
Description
Static and dynamic balance
Timepoint
Before and after 8 week intervention
Method of measurement
Pedoscan
Intervention groups
1
Description
Intervention group: Intervention group: The intervention group performs sensorimotor training with visual feedback for 8 weeks, 3 sessions per week, and 45-60 minutes per session. A mirror will be used to provide visual feedback.
Category
Rehabilitation
2
Description
Control group: the control group performs their normal activities for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
Z_raisi13@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Hamed Safikhani
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 2000
Email
d-research@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university
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
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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