Protocol summary

Summary
osteoarthritis is the degeneration of joint cartilage and subchondral bone that cause pain,morning stiffness and disability in patients.Knee osteoarthritis is the most prevalent rheumatism disease worldwide.Patients who suffer from knee osteoarthritis ,walk with bent knee.due to knee flexion ,center of pressure of knee move backward ,and therefore flexion moment is increase and quadriceps muscle must work with more forces and thereafter compressive force on patellofemoral joint is increased.The treatment that can move center of pressure anteriorly,such as walking on inclined surface , cause decrease of flexion moment arm in knee joint.People who participate in this research ,at first,complete 3 questionnaires that involve demographic data,knee injury and osteoarthritis out come score (KOOS)and visual analogue scale (VAS) . Then knee flexion and extension range of motion ,self selected walking speed and stride length are measured.Afterward ,participants are divided in two groups according to random assignment by individual method.Control group ricieve 10 session routine physiotherapy . Intervention group recieve 10 session routine physiotherapy with 2 set walking at 1/1 meter per seconds on treadmill while treadmill surface is inclined to 8 degree.Each set remaine 15 minutes.The parameteres that described are measured again after the end of 10 session physiotherapy and 20 days afterward.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT20171115034920N1
Registration date: 2017-11-15, 1396/08/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
parisa sedaghatnejad
Name of organization / entity
university of social welfare and rehabilitation science
Country
Iran (Islamic Republic of)
Phone
+98 26 3223 6984
Email address
pa.sedaghatnejad@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of uphill walking on pain, range of motion, stride length, walking speed and disability in patients with knee osteoarthritis
Public title
the effect of uphill walking on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : 2 and 3 grade of osteoarthritis based on Kell grenade Lawrence scale don't receive physiotherapy treatment for knee osteoarthritis ,one year before entry to research don't take intra articular injection from 3 month before entry to research don't have history of trauma,fracture,dislocation and surgery of knee joint lack of BMI above 30 kilogeram per square meter worst reported pain during last week , at least is 30 mm on the VAS lack of systemic arthritis don't use of walking assisting device exclusion criteria: injury or severe hypotension as a result of intervention intolerable increase of pain disinclination to participate in research 2 continuous session absence
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 science
Street address
koodakyar alleu, daneshjoo street, evin
City
tehran
Postal code
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.USWR.REC.1396.183

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified

Primary outcomes

1

Description
pain
Timepoint
preintervention-the end of 10 session- 20 days after the end of intervention
Method of measurement
visual analogue scale

2

Description
range of motion
Timepoint
preintervention-the end of 10 session- 20 days after the end of intervention
Method of measurement
goniometer

3

Description
walking speed
Timepoint
preintervention-the end of 10 session- 20 days after the end of intervention
Method of measurement
10 meter walking test

4

Description
stride length
Timepoint
preintervention-the end of 10 session- 20 days after the end of intervention
Method of measurement
distance division on stride number

Secondary outcomes

1

Description
disability
Timepoint
preintervention-the end of 10 session- 20 days after the end of intervention
Method of measurement
Knee injury and Osteoarthritis Outcome Score questionary

Intervention groups

1

Description
intervention: routine physiotherapy + walking on inclined treadmill
Category
Rehabilitation

2

Description
control: routine physiotherapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
shams physiotherapy
Full name of responsible person
mohsen shams
Street address
Sina building , No339 , east 196 street , shahed square , tehranpars
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
university of social welfare and rehabilitation science
Full name of responsible person
parisa sedaghatnejad
Street address
no51 nabreh street azadeqan karaj city
City
karaj
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 science
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
parisa sedaghatnejad
Position
master
Other areas of specialty/work
Street address
no51 nabreh street azadeqan karaj city
City
karaj
Postal code
3154744948
Phone
+98 26 3223 6984
Fax
Email
p.sedaghat93@gmail.com
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
parisa sedaghatnejad
Position
masters
Other areas of specialty/work
Street address
no51 nabreh street azadeqan karaj city
City
karaj
Postal code
3154744948
Phone
+98 26 3223 6984
Fax
Email
p.sedaghat93@gmail.com
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
parisa sedaghatnejad
Position
masters student
Other areas of specialty/work
Street address
no51 nabreh street azadeqan karaj city
City
karaj
Postal code
3154744948
Phone
+98 26 3223 6984
Fax
Email
p.sedaghat93@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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