Protocol summary
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Study aim
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The aim of this study is to consider the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on some of the knee osteoarthritis symptoms including pain intensity, disability, knee joint range of motion, stride length and walking speed in patients with osteoarthritis
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Design
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Randomized clinical trial with control group, community based and practical, with parallel groups, no blinded, on 30 patients, randomization was performed by even-odd digits.
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Settings and conduct
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The study was performed at central Farhangian clinic in Tehran. Sampling was non-probability (convenient sampling) and patients were randomly allocated in two intervention and control groups (each groups included 15 patients). After interventions; pain, disability, range of motion, stride length and walking speed were measured at the beginning and at the end of the interventions and following 20 days after the last session too. Blinding was not performed in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : The patients with knee osteoarthritis with intensity of 2 or 3 degree in Kellgren and Lawrence scale ; the age of patients is 40 - 65 years old; The most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale. Non inclusion criteria: Bone Mass Intensity is more than 30 kg/m2 ; suffering from systemic arthritis.
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Intervention groups
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Both groups will be treated by routine physiotherapy program for 10 sessions including: continuous ultrasound for 6 minutes on anterior and posterior of knee, then conventional TENS with hot pack around knee for 20 minutes and several type of exercises, but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy.
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Main outcome variables
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pain intensity , disability , knee joint range of motion , stride length and walking speed
General information
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Reason for update
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Trial completion
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017071535097N1
Registration date:
2017-11-19, 1396/08/28
Registration timing:
prospective
Last update:
2020-07-23, 1399/05/02
Update count:
1
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Registration date
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2017-11-19, 1396/08/28
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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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personal funding source
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Expected recruitment start date
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2017-12-01, 1396/09/10
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Expected recruitment end date
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2018-03-01, 1396/12/10
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Actual recruitment start date
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2017-12-01, 1396/09/10
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Actual recruitment end date
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2018-04-09, 1397/01/20
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Trial completion date
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2018-09-11, 1397/06/20
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Scientific title
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The effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain, range of motion, stride length, walking speed and disability in patients with knee osteoartritis
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Public title
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The effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of patient between 40-65 years old
Knee DJD intensity is 2-3 degree on Kellgren & Lawrence
Symptoms beginning is gradual
Not being occur after trauma or accident or fracture
The most pain intensity that patient suffered in the last week would be at least 30 of 100 on Visual Analog Scale
Exclusion criteria:
Joint injection therapy in recent 3 months
Knee joint ligament injury
Body Mass Index is more than 30 kg/m2
Systemic arthritis
Using cane or crutch or walker
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Age
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From 40 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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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First patient and as the same manner the rest of patients who had odd numbers were placed in control group and second patient and the rest of patients with even numbers in intervention group
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2017-10-18, 1396/07/26
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Ethics committee reference number
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IR.USWR.REC.1396.184
Health conditions studied
1
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Description of health condition studied
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Osteoartritis
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ICD-10 code
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M17
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ICD-10 code description
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Gonarthrosis [arthrosis of knee]
Primary outcomes
1
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Description
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Pain Intensity
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Timepoint
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Befor intervention - After end of the intervention - 20 days following end of the intervention
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Method of measurement
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Visual Analog Scale
2
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Description
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Rang Of Motion
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Timepoint
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Befor intervention - After end of intervention - 20 days following end of the intervention
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Method of measurement
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Goniometer
3
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Description
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Walking speed
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Timepoint
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Befor intervention - After end of intervention - 20 days following end of the intervention
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Method of measurement
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10 meter walk test
4
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Description
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Stride length
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Timepoint
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Befor intervention - After end of intervention - 20 days following end of the intervention
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Method of measurement
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To meter walked 15 stride then division it per 15
5
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Description
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Disability
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Timepoint
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Befor intervention - After end of intervention - 20 days following end of the intervention
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Method of measurement
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Knee injury and Osteoartritis Outcome Score
Intervention groups
1
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Description
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Intervention group: Walking with reverse heel shoes in 15 minutes for two times in each session during 10 session plus routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles
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Category
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Rehabilitation
2
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Description
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Control group: Routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles
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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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University of Social Welfare and Rehabilitation Sciences
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available