Protocol summary
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Study aim
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To investigate the effect of isolated hip abductor and external rotator muscle strengthening on dynamic knee valgus during single-leg landing.
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Design
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Two arm parallel group randomized Clinical Trial with blinded outcome assessment
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Settings and conduct
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Thirty-two males with knee valgus angle more than 9 degree were randomized into a training (n=16) or control group (n=16). The training group carried out 8 weeks of bilateral hip abductor and external rotator strengthening 3 times per week. Pre and post-test hip strength were measured with isokinetic dynamometer (Kin-Com) and motion capture data were collected during 3 single-leg landing trials. Pelvis, hip and knee angles were estimated using QTM and Visual 3D software. the study was carried out in Azad Republic university's laboratory.
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Participants/Inclusion and exclusion criteria
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To be considered for the study, subjects had to be male (age 19 to 23) and show knee valgus angle more than 8 degrees during jump-landing task . All subjects had a history of at least 2 years participation in/or football, futsal, handball and volleyball, no history of lower extremity surgery, no regular hip muscles strengthening program, no participation in an ACL injury prevention program, no lower extremity injury within 6 months before the study, no limitation in ankle dorsiflexion range of motion and no obvious misalignment in lower extremity
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Intervention groups
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Intervention group: 8 weeks of bilateral isolated hip abductor and external rotator strengthening exercise
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Main outcome variables
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Knee valgus angle; hip muscle strength
General information
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Reason for update
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Provide more information about randomization
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190511043552N1
Registration date:
2019-09-28, 1398/07/06
Registration timing:
retrospective
Last update:
2022-03-22, 1401/01/02
Update count:
1
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Registration date
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2019-09-28, 1398/07/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-06, 1398/04/15
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Expected recruitment end date
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2019-07-16, 1398/04/25
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Actual recruitment start date
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2019-07-06, 1398/04/15
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Actual recruitment end date
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2019-07-09, 1398/04/18
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Trial completion date
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2019-09-19, 1398/06/28
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Scientific title
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The effects of isolated hip abductor and external rotator muscle strengthening on dynamic knee valgus during single leg landing
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Public title
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The effects hip muscles strengthening on dynamic knee valgus
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
subjects had to be male (age 19 to 23)
shown knee valgus angle more than 8 degree during jump-landing task
subjects had no history of lower extremity surgery
no regular hip muscles strengthening program
no lower extremity injury within 6 months before the study
no limitation in ankle dorsiflexion range of motion
no obvious misalignment in lower extremity
Exclusion criteria:
participated in an ACL injury prevention program
knee valgus angle less than 8 degree during jump-landing task
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Age
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From 20 years old to 25 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
36
Actual sample size reached:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization of participants was performed through drawing opaque envelopes numbered 1 or 2 by an independent coordinator, not otherwise involved in the study, who created an allocation sequence that assigned participants to the training or control groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants and research assistants (trainers and data analyzer) were blind to group allocation. Group allocation prepared by an independent coordinator were not associated with the rendition of the exercise program. Each groups had independed trainer, not otherwise involved in the study.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-30, 1398/04/09
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Ethics committee reference number
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IR.UI.REC.1398.023
Health conditions studied
1
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Description of health condition studied
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knee valgus angle
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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knee valgus angle: medial knee deviation
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Timepoint
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measurement at the baseline and after eight week exercise
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Method of measurement
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Visual 3D motion analysis software
2
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Description
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hip muscles strength
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Timepoint
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measurement at the baseline and after eight week exercise
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Method of measurement
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isokinetic dynamometer
Intervention groups
1
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Description
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Intervention group: Eight weeks of Isolated hip abductor and external rotator strengthening 3 times per week.
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Category
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Prevention
2
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Description
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Control group: daily activity
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The university of Isfahan
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The entire data of individual is publicly available after it will be unidentifiable
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When the data will become available and for how long
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get started since 2019
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To whom data/document is available
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All researchers in sport medicine and sport coaches
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Under which criteria data/document could be used
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There are no special condition and everyone can have access
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From where data/document is obtainable
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Mahdi Safari bak_ 09151214977_ m.safari950@gmail.com
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What processes are involved for a request to access data/document
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They can access to the data by sending an email or call to the authors after published papers a reports
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Comments
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