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
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 . 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 . Exclusion criteria : Bone Mass Intensity is more than 30 kg/m2 ; The patient involve in systemic arthritis . The accessible population include all patients in Tehran city that refer to central farhangian clinic for knee osteoarthritis physiotherapy treatment . Sampling size is at least 30 subjects and sampling is non-probability (convenient sampling) and randomize them into two intervention and control group; both of them will be treated by routine physiotherapy program for 10 sessions ,but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy . Then will be measured all of outcomes including pain, disability, range of motion, stride length and walking speed at the beginning of intervention and at the end and following 20 days after the last session too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071535097N1
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Mohsen Shams
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7739 2705
Email address
mo.shams@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
personal funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
the effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : age of patient between 40-65 years old ; knee DJD intensity is 2-3 degree on Kellgren & Lawrence scale ; symptoms beginning is gradual and not be accure after trauma or accident or fracture ; the most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale . Exclusion criteria ; joint injection therapy in recent 3 months ; knee joint ligament injury; Bone Mass Intensity is more than 30 kg/m2 ; systemic arthritis ; using cane or crutch or walker
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
City
Tehran
Postal code
1985713834
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.USWR.REC.1396.184
Health conditions studied
1
Description of health condition studied
Osteoartritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Pain Intensity
Timepoint
Befor intervention - After end of the intervention - 20 days following end of the intervention
Method of measurement
Visual Analog Scale
2
Description
Rang Of Motion
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
Goniometer
3
Description
Walking speed
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
10 meter walk test
4
Description
Stride length
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
To meter walked 15 stride then division it per 15
5
Description
Disability
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
Knee injury and Osteoartritis Outcome Score
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Rehabilitation
2
Description
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
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Central Farhangian Clinic
Full name of responsible person
Mohsen Shams
Street address
Next to Fayazbakhsh Bus Terminal , Imam Khomeini Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohsen Shams
Position
Master Student of Physiotherapy
Other areas of specialty/work
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Fax
Email
mo.shams@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohsen Shams
Position
Master Student of Physiotherapy
Other areas of specialty/work
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Fax
Email
mo.shams@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohsen Shams
Position
Master student of Physiotherapy
Other areas of specialty/work
Street address
Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Fax
Email
mo.shams@uswr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)