The purpose of the present study was to investigate the Effect of Eight-Week Elastic Walking Exercise on the Pattern of Plantar Pressure Distribution in Women with Chronic Low Back Pain during Walking
Design
The study consisted of 20 women with low back pain, who were randomly divided into control (n=11) and intervention (n=9) groups. There was no blinding in the study.
Settings and conduct
After identifying the groups, the intervention group performed elastic walking exercise For 8 weeks; three times a week; each session 45 minutes.The dependent variables were measured in both groups before and after the 8-week intervention period. The research was conducted at Mohaghegh Ardebili University.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the pain in the waist; non-athletic subjects.
Non-inclusion criteria: history of surgery in the lower back and lower extremities; spinal anomalies; osteoporosis; fracture or disturbance in the neck area.
Intervention groups
The intervention group included 9 women with low back pain and the intervention consisted of 8 week elastic walking exercise in three sessions per week.
The control group, consisted of 11 women with low back pain, did not do any exercise.
Main outcome variables
The plantar pressure variables: the peak of vertical ground reaction forces; the time to peak of ground reaction forces; loading rate; the peak of plantar pressure on the ten foot regions; the peak of ground reaction forces on the ten foot regions; displacement of the pressure center in two internal-external (copx) and anterior-posterior (copy) lines.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043304N1
Registration date:2019-06-30, 1398/04/09
Registration timing:retrospective
Last update:2019-06-30, 1398/04/09
Update count:0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Farnaz seify
Name of organization / entity
University Of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5626
Email address
f.seify@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
2018-09-21, 1397/06/30
Scientific title
The Effect of Eight-Week Elastic Walking Exercise on the Pattern of Plantar Pressure Distribution in Women with Chronic Low Back Pain during Walking
Public title
Effect of walking on treatment of low back pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic low back pain with more than one year history
Non-athlete
Exclusion criteria:
History of surgery in the lower back and lower extremities
spinal anomalies
osteoporosis
Fracture or disturbance in the neck region
Age
From 36 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Random unit: Individual
Randomization tool: sealed envelope
The names of the participants were written in separate papers and randomly divided into two parts with an equal number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil, Daneshgah st. Ardabil Complex University, Deputy Research and Technology
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.ARUMS.REC.1397.032
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
the peak of vertical ground reaction forces
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
2
Description
the time to peak of ground reaction forces
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
3
Description
loading rate
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
4
Description
the peak of plantar pressure on the ten foot regions
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
5
Description
the peak of ground reaction forces on the ten foot regions
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
6
Description
displacement of the pressure center in internal-external line (copx)
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
7
Description
displacement of the pressure center in anterior-posterior line (copy)
Timepoint
Before starting the exercise period and one day after the end of the period
Method of measurement
foot scan system (Sampling rate 300 Hz)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention was elastic walking training three times a week for 8 weeks.In an elastic walking program, walking with lower legs and without bending knees; having tall steps; bearing the weight on the center of the heel at the rear foot; weight bearing on the back of the thumb, preventing hip drop; elastic breathing while walking, loosening the muscles of the waist to let down the trail down; upper tilt of the upper body and forward swirling upper extremities were emphasized.
Category
Rehabilitation
2
Description
Control group: The subjects of this group did not have any training program. To control the lack of training of this group, making call by telephone, viewing and questioning the subjects were considered.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center, University of Mohaghegh Ardabili
Full name of responsible person
Seyed Majid Alavi-Mehr
Street address
Health Center, Ground floor, Faculty of Education and Psychology, University of Mohaghegh Ardabili, University Street, Ardabil
Research Grant of the University of Mohaghegh Ardabil
Grant code / Reference number
618
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Mohaghegh Ardabili
Proportion provided by this source
100
Public or private sector
Public
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
The University of Mohaghegh Ardabili
Full name of responsible person
Farnaz Seify
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Education and Psychology, University of Mohaghegh Ardabili, University Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3150 5626
Email
f.seify@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Farnaz Seify
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Education and Psychology, University of Mohaghegh Ardabili, University Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3150 5626
Email
f.seify@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Farnaz Seify
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Education and Psychology, University of Mohaghegh Ardabili, University Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3150 5626
Email
f.seify@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the variables measured in the present study will be shared as a result of statistical analysis in the section of the results of a scientific and research paper.
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
Accessible for all individuals
Under which criteria data/document could be used
Data will be provided to individuals in order to start implementing the same plan and respond to some ambiguities in the topic under discussion.
From where data/document is obtainable
Dr Farnaz Seify, f.seify@ yahoo.com
What processes are involved for a request to access data/document
After receiving a full explanation of the reason for the need for data, they will be provided by correspondence with the email address and provide the general objectives of the proposed proposal.