Protocol summary
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Study aim
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the effect of subject specific Foot progression angle retraining on the kinetics, kinematic, muscle activation and functional ability during walking in patients with knee osteoarthritis
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Design
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Two arm parallel group, a single blinded randomised control trial
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Settings and conduct
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place to do: tarbiat modares university
way to do:6-weak gait retraining and assessment of parameters before and after training
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Participants/Inclusion and exclusion criteria
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osteoarthritis patients with grade II & III according to Kellgren-Lawrence scale in one knee or, if bilateral, being mild in one side
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Intervention groups
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intervention group: gait retraining as subject specific Toe out or Toe in
control group: normal walking
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Main outcome variables
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knee joint moment, muscle activation, pain, functional activity,quality of life
General information
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Reason for update
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Acronym
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FPA, TO, TI
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IRCT registration information
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IRCT registration number:
IRCT20101017004952N8
Registration date:
2019-10-09, 1398/07/17
Registration timing:
prospective
Last update:
2019-10-31, 1398/08/09
Update count:
1
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Registration date
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2019-10-09, 1398/07/17
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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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2019-10-23, 1398/08/01
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Expected recruitment end date
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2020-07-21, 1399/04/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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the effect of subject specific Foot progression angle retraining on the kinetics, kinematic, muscle activation and functional ability during walking in patients with knee osteoarthritis.
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Public title
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the effect of subject specific Foot progression angle retraining in knee osteoarthritis.
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Definite OA Grade II & III as defined by the Kellgren-Lawrence scale in one knee or, if bilateral, being mild in one side
BMI: Between 25 and 30
Ability to walk independently on an even surface without any assistive devices
Minimum age 45 and maximum 65 years old
Exclusion criteria:
History of intra-articular injections over the past 6 months (such as hyaluronic acid, hydrocortisone and PRP)
History of regular physical activity in the past 3 months (at least 2 or 3 times per week and at least half an hour each time
History of musculoskeletal disorders and lower extremity joint injuries affecting balance
Severe TI or TO (57/7 ± 5/7)
Pes Planus (Flat foot) (rigid and flexible), Pes cavus (High arch)
Any malalignment of lower extremity which is evident by observation (Varus angel > 5֯ and Valgus angel > 15֯)
History of knee and lower extremity surgery, severe muscle weakness in lower extremity, MMT lower than 3/5
History of neurological, vestibular, neuromuscular diseases (Diabetes and Neurapathy), chronic orthopedic disorders of the trunk and lower extremities (Rheumatoid Arthritis), visual impairments, inability to comprehend commands
Osteoporosis
Taking medications not prescribed by a Rheumatologist.
Unwillingness to participate in the study for any reason
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Age
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From 45 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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blocking randomization using the sealed, opaque, and stapled envelopes by an independent person
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Assessment and data acquisition will be performed by an expert in the Movement Disorders Laboratory that is blinded about grouping and kind of intervention
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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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2019-03-17, 1397/12/26
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Ethics committee reference number
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IR.MODARES.REC.1398.004
Health conditions studied
1
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Description of health condition studied
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knee osteoarthritis disease
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ICD-10 code
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M15.0
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ICD-10 code description
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Primary generalized (osteo)arthritis
Primary outcomes
1
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Description
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knee adduction moment
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Timepoint
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before and after six-week retraining
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Method of measurement
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motion analysis system, nexus software
2
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Description
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knee flexion moment
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Timepoint
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before and after six-week retraining
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Method of measurement
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motion analysis system, nexus software
3
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Description
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Muscle activation
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Timepoint
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before and after six-week retraining
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Method of measurement
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Electromyography
Secondary outcomes
1
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Description
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pain
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Timepoint
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before and after six-week retraining
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Method of measurement
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visual analog scale
2
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Description
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Quality of life
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Timepoint
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before and after six-week retraining
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Method of measurement
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SF-36 questionnaire and WOMAC
3
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Description
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functional activity
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Timepoint
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before and after six-week retraining
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Method of measurement
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8-walking test and Timed up and go test
Intervention groups
1
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Description
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Intervention group: gait retraining
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Category
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Rehabilitation
2
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Description
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Intervention group:change the walking pattern(Toe in or Toe out) on the basis the first session assessment
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Category
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Rehabilitation
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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Tarbiat modares university
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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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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demographic data, main variable and its consequences
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When the data will become available and for how long
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6 month after publication results
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To whom data/document is available
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only for researchers
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Under which criteria data/document could be used
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they do not have permission to process the data
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From where data/document is obtainable
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Samaneh gholami
09125343099
samaneh_gh_65@yahoo.com
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What processes are involved for a request to access data/document
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he or she must by email indicate the title of the research proposal and the reason for the request
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Comments
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