Protocol summary

Study aim
Effect of rehabilitation treatment on pain, muscle force, physical function and quality of life in officer students with dynamic valgus of lower limb
Design
Clinical trial with an intervention group and a control group, with parallel groups, single blinded, randomly constructed, on 40 people in each group
Settings and conduct
In this study, eligible individuals among the officer students of Imam Hossein University who refer to the university clinic, will enter the study and be randomly assigned to two intervention and control groups. The researcher will conduct therapeutic interventions for each group within six weeks. Data collection, outcome assessment, and data analysis will be done by another colleague and the researcher will be blind to this process. The data collection tools includes lower limb functioning questionnaire, quality of life questionnaire, numerical pain scale, and manual dynamo meter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: knee rotation syndrome with valgus, pain at least 3 on the numerical pain scale, knee pain when running, jumping, sitting and standing up Exclusion criteria: trauma, injury to anterior cruciate ligament
Intervention groups
Intervention group: knee strengthening exercises (specific strengthening of Vastus medialis oblique muscle), hip strengthening exercises (specific strengthening of hip abductor and external rotator muscles), taping and biofeedback correction of wrong biomechanical patterns of the lower limbs in daily functions. Control group: knee strengthening exercises (general strengthening of the quadriceps muscle), hip strengthening exercises (general strengthening of the muscles around the hip). In both groups, the interventions will be conducted for six weeks and three sessions per week.
Main outcome variables
Pain intensity; maximum muscle isometric contraction force; physical performance; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048523N1
Registration date: 2022-11-17, 1401/08/26
Registration timing: prospective

Last update: 2022-11-17, 1401/08/26
Update count: 0
Registration date
2022-11-17, 1401/08/26
Registrant information
Name
Saeed Mikaili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 5422
Email address
saeed.mikaely@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of comprehensive rehabilitation treatment on pain, muscle force, physical function and quality of life in officer students with dynamic valgus of the lower limb
Public title
Effect of rehabilitation treatment in dynamic valgus of lower limb
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with knee rotation syndrome along with valgus Pain at least 3 score based on the numerical pain scale Knee pain when running, jumping sitting, and standing up
Exclusion criteria:
Trauma to knee Injury to anterior cruciate ligament
Age
From 18 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: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be performed as block randomization method. This method is implemented considering blocks of 4, so that the total number of possible permutations of four is 6, including: ABAB, ABBA, BAAB, BABA AABB, BBAA. Eligible people are placed in one of the following groups based on quadruple blocks, A: intervention group, B: control group. To create a random sequence, we will number the possible blocks (6 blocks) from 1 to 6, we will select the block numbers from the random number table, and based on these numbers, we will determine the sequence of blocks in each group. We need 20 blocks to select 80 people. In this study, the unit of randomization is the individual. Allocation concealment will be done by using sequentially numbered, sealed opaque envelopes in a random sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
The main researcher will be blinded to the selection and randomization of the participants. The treatment in the intervention and control groups will be done by the main researcher. Data collection before and after the intervention will be done by another colleague who is blinded like the main researcher. The outcomes evaluation and data statistical analysis will be done by the statistical consultant of the project and the main researcher will be also blinded in these fields.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
Baqiyatallah University of Medical Sciences., South Sheikh Bahai., Mollasadea St., Vanak Sq
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.062

Health conditions studied

1

Description of health condition studied
Genu Valgum (Knock knee)
ICD-10 code
M21.06
ICD-10 code description
Valgus deformity, not elsewhere classified, knee

Primary outcomes

1

Description
Pain intensity
Timepoint
Measurement of pain intensity at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention).
Method of measurement
Numerical pain rating scale

2

Description
Maximum muscle isometric contraction force
Timepoint
Measurement of maximum muscle isometric contraction force at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention).
Method of measurement
Hand dynamo-meter

3

Description
Physical performance level
Timepoint
Measurement of physical performance level at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention).
Method of measurement
Lower extremity functional scale

4

Description
Quality of life
Timepoint
Measurement of level of quality of life at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention).
Method of measurement
36-question quality of life questionnaire

Secondary outcomes

1

Description
Thickness and angle fibers of vastus medialis and leteralis oblique muscles
Timepoint
Measurement of thickness and angle of muscle fibers at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention).
Method of measurement
Ultrasonography

2

Description
Joint distance of knee
Timepoint
Measurement of joint distance at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention).
Method of measurement
Ultrasonography

Intervention groups

1

Description
Intervention group: knee strengthening exercises (specific strengthening of vastus medialis oblique muscle), hip strengthening exercises (specific strengthening of hip abductor and external rotator muscles), taping and biofeedback correction of wrong biomechanical patterns of lower limbs in daily functions. The interventions will be conducted for six weeks and three sessions per week.
Category
Rehabilitation

2

Description
Control group: knee strengthening exercises (general strengthening of the quadriceps muscle), hip strengthening exercises (general strengthening of the muscles around the hip). The interventions will be conducted for six weeks and three sessions per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein University
Full name of responsible person
Abolfazl Shakibaee
Street address
Imam Hossein University, Lashgarak Bridge, Shahid Babaei Highway
City
Tehran
Province
Tehran
Postal code
1698715861
Phone
+98 21 7710 5776
Email
shakibaee.abolfazl@yahoo.com
Web page address
https://ihuo.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
AbbasAli Imani Fooladi
Street address
Baqiyatallah University of Medical Sciences., South Sheikh Bahai., Mollasadea St., Vanak Sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5256
Email
imanifouladi.a@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Mikaili
Position
PhD candidate of physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
saeed.mikaely@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Mikaili
Position
PhD candidate of physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
saeed.mikaely@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Mikaili
Position
PhD candidate Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
saeed.mikaely@yahoo.com

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
All above will be published in the article.
When the data will become available and for how long
After the article publication
To whom data/document is available
Researchers and students in academic centers
Under which criteria data/document could be used
Other researchers and therapists in the rehabilitation and medical field can use this use the data of this study after the article publication.
From where data/document is obtainable
After the article publication, people can find the article by searching in internet and access the data.
What processes are involved for a request to access data/document
After the article publication, people can find the article by searching in internet and access the data.
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