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Effects of retrowalking training protocol on Gait Kinematics and kinetics parameters of patients with medial knee osteoarthritis

Protocol summary

Study aim
The aim of this study was to compare the Gait Kinematics and kinetics parameters in male patients according to severity of knee osteoarthritis during gait
Design
This study was performed with a pretest-posttest design including 21 healthy men and 42 male patients with knee osteoarthritis who were divided into experimental and control groups .
Settings and conduct
Backward gait training protocol including 6 weeks study, 3 sessions per weeks . Each exercise session began with warm up exercises , followed by backward gait exercises and ended up by cool-down exercises. Backward gait training protocol including Interval training (3 set, 2-4-6 reps), continuous training (2sets,2 and 3 minutes), Stretching exercises(3 minute),Strength training , Exercise intensity increased in the second week. Patients were stopped immediately once they report pain or discomfort during retro gait.
Participants/Inclusion and exclusion criteria
The patients were knee osteoarthritis according to the Kelgerand and Lawrence index with grade 2 and 3 osteoarthritis. All patients were able to perform activities of daily living including walking, running, up and down stairs, Radiological symptoms of osteoarthritis in the knee, pain and tenderness on the medial side of the knee. All patients with knee OA were not in the acute phase of the disease. Not having history of trauma, injury or surgery, lower limb fracture , and joint threatening diseases, The lack of a long history of drug use and non-drug addiction.
Intervention groups
The experimental group performed backward gait training for six weeks.
Main outcome variables
A) kinematics parameters (the Spatial, Temporal, Distance variables and ROMs), B) kinetics parameters (vertical ground reaction forces, Peak adduction moment and adduction moment impulse). A Vicon motion analysis system with six T-series cameras and a Kistler force plate used to record.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170712035052N1
Registration date: 2019-03-08, 1397/12/17
Registration timing: retrospective

Last update: 2019-03-08, 1397/12/17
Update count: 0
Registration date
2019-03-08, 1397/12/17
Registrant information
Name
Ali Jalalvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3448 1000
Email address
jalalvand_ali@iauh.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
2015-06-05, 1394/03/15
Actual recruitment end date
2015-08-06, 1394/05/15
Trial completion date
2016-01-27, 1394/11/07
Scientific title
Effects of retrowalking training protocol on Gait Kinematics and kinetics parameters of patients with medial knee osteoarthritis
Public title
Effect of Backward Gait on Biomechanical Walking Parameters in Patients with Knee Osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients were able to perform activities of daily living including walking, running, up and down stairs The patients were knee osteoarthritis according to the Kelgerand and Lawrence index with grade 2 and 3 osteoarthritis
Exclusion criteria:
No patient had problems in standing and walking Radiological symptoms of osteoarthritis in the knee, pain and tenderness on the medial side of the knee. All patients with knee OA were not in the acute phase of the disease The lack of consumption (non-steroid anti-inflammatory) from a week before entering the study. Not having history of trauma, injury or surgery, and lower limb fracture Not having history of joint threatening diseases (Osteonecrosis, diabetes, osteoporosis, rheumatoid arthritis, musculoskeletal neurological disease) The lack of a long history of drug use and non-drug addiction
Age
From 45 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Actual sample size reached: 63
Randomization (investigator's opinion)
Not 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
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.UMSHA.REC.1394.110

Health conditions studied

1

Description of health condition studied
medial knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
kinematics parameters (the Spatial, Temporal, Distance variables and ROMs)
Timepoint
This study was performed with a pretest-posttest design in two groups (healthy and patient) and an experimental group (subjects with medial knee osteoarthritis).
Method of measurement
A Vicon motion analysis system with T-Series cameras were used to measure the Kinematics parameters. The Kinematics parameters of gait including were calculated by Vicon Nexus 1.8.5 software in pretest-posttest trials. All data were then extracted by Polygon 3.5.1.

2

Description
kinetics parameters (vertical ground reaction forces, Peak adduction moment and adduction moment impulse)
Timepoint
This study was performed with a pretest-posttest design in two groups (healthy and patient) and an experimental group (subjects with medial knee osteoarthritis).
Method of measurement
A Vicon motion analysis system with four T-Series cameras and two Kistler force plates were used to measure parameters by Vicon Nexus 1.8.5 , Polygon 4.1.2 software .

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The subjects were 21 healthy men and 42 male patients with knee osteoarthritis who were divided into experimental and control groups according to the Kellgren and Lawrence radiologic scale and the visual analogue scale.The effects of retro-gait training protocol on Kinematics and kinetics parameters knee osteoarthritis gait hasn’t been considered in the literature. Effects of retro walking: reducing shear force, increasing extensor moment and to gain flexibility around knee, decrease in eccentric quadriceps activity , patellofemoral joint stresses that are often associated with anterior knee pain. Therefore, these advantages make retro-gait a safe and effective component of rehabilitation programs. The experimental group performed backward gait training for six weeks, 3 sessions per weeks. Subjects accomplish a five minute warm-up on followed by backward gait exercises. Backward gait training protocol including Interval training (3 set, 2-4-6 reps), continuous training (2sets,2 and 3 minutes), Stretching exercises(3 minute), Strength training , Exercise intensity increased in the second week. Patients were stopped immediately once they report pain or discomfort during retro gait. Each exercise session began with warm up exercises , followed by backward gait exercises and ended up by cool-down exercises.
Category
Rehabilitation

2

Description
Control group: The 42 patients with knee OA were divided into experimental and control groups according to the Kellgren and Lawrence radiologic scale and the visual analogue scale. Participants in the control group did not receive any training.
Category
Other

3

Description
Control group: Furthermore, among the staff of the university 21 healthy male peers were selected as normal controls. The participants in the normal control group did not receive any training during the study period.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheykh Al-Raees Clinic
Full name of responsible person
Alireza Yavari Kia
Street address
District 1,Khajeh Rashid Blvd, Hamadan Province, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6644453936
Phone
+98 81 3832 1006
Email
info@dr-yavarikia.ir
Web page address
http://sheykhoreis.umsha.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Reza Pirhayati
Street address
Hamadan Province, Hamedan, Professor Mussivand Blvd
City
Hamedan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Fax
+98 81 3449 4059
Email
Alirezapirhayati@gmail.com
Web page address
https://www.iauh.ac.ir/team/dr-alireza-pirhayati/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Jalalvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Hamadan Province, Hamedan, Professor Mussivand Blvd
City
Hamedan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Fax
+98 81 3449 4059
Email
jalalvand_ali@iauh.ac.ir
Web page address
https://www.iauh.ac.ir/contact/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Jalalvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Hamadan Province, Hamedan, Professor Mussivand Blvd
City
Hamedan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Fax
+98 81 3449 4059
Email
jalalvand_ali@iauh.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Jalalvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Hamadan Province, Hamedan, Professor Mussivand Blvd
City
Hamedan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Fax
+98 81 3449 4059
Email
jalalvand_ali@iauh.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data are available for research use
When the data will become available and for how long
1398
To whom data/document is available
clinical researchers working in academia
Under which criteria data/document could be used
For other people who work at universities
From where data/document is obtainable
jalalvand_ali@yahoo.com
What processes are involved for a request to access data/document
A week
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