Immediate effect of rocker shoes on balance and temporo-spatial parameters of gait in subjects with multiple sclerosis with drop foot, volunteer for using flexible ankle orthosis
The effect and evaluation of rocker shoes on balance and temporo-spatial parameters in subjects with multiple sclerosis with drop foot, volunteer for using flexible ankle orthosis
Design
This study is a prospective, before and after, interventional study. Ten patients with multiple sclerosis who are under the supervision of Isfahan multiple sclerosis association are examined and evaluated by a neurologist. Neurological examination will be performed using the Extensive Disability Scoring Criteria (EDSS), which is the most common tool for measuring inflammatory disability.
Settings and conduct
The site of study is the musculoskeletal center of Isfahan University of Medical Sciences.
The study is one-sided blind. The patient does not know the type of intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 18-50 years;
The degree of disability is moderate and the EDSS score is in the range of 3.0-6.0;
Can walk at least 30 feet independently or with the help of a cane;
Weakness in the dorsiflexor muscles of the ankle (drop foot);
The score of the modified Assyrian scale is less than 2.
Non-inclusion criteria:
Exacerbation of MS in the last 3 months;
Prescribing drugs for fatigue or mobility such as phamperidine, amantadine;
Severe heart or respiratory problems;
Musculoskeletal disorders or severe pain that prevents walking
Intervention groups
In this study, we use PLS orthosis and rocker sole to control the foot drop and promote of their gait parameters.
Main outcome variables
Balance;
Temporo-spatial parameters of gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047459N3
Registration date:2020-11-02, 1399/08/12
Registration timing:retrospective
Last update:2020-11-02, 1399/08/12
Update count:0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Masoud Rafiaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5043
Email address
ma.rafiaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2020-08-21, 1399/05/31
Trial completion date
2020-09-21, 1399/06/31
Scientific title
Immediate effect of rocker shoes on balance and temporo-spatial parameters of gait in subjects with multiple sclerosis with drop foot, volunteer for using flexible ankle orthosis
Public title
Effect of rocker shoes on balance and gait parameters in subjects with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-50 years
The disability rate is moderate and the EDSS score is in the range of 3.0-6.0
Can walk at least 30 feet independently or with the help of a cane.
Weakness in the dorsiflexor muscles of the ankle (drop foot)
The score of the modified Assyrian scale is less than 2
Exclusion criteria:
Exacerbation of MS in the last 3 months
Prescribing medications for fatigue or mobility such as phamperidine, amantadine
Severe heart or respiratory problems
Musculoskeletal disorders or severe pain that prevents walking
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Isfahan University of Medical Sciences
Street address
Rehabilitation college, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-04-24, 1399/02/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.091
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance: The center of gravity of an object can be considered as the equilibrium point of that object. If all the forces acting on a part are in balance, that object is at rest or moving steadily.
Timepoint
before and after intervention
Method of measurement
force plate
2
Description
number of steps per minute,
Timepoint
before and after intervention
Method of measurement
Camera
3
Description
walking speed,
Timepoint
before and after intervention
Method of measurement
Camera
4
Description
stride length
Timepoint
before and after intervention
Method of measurement
Camera
5
Description
static phase percentage
Timepoint
before and after intervention
Method of measurement
Camera
Secondary outcomes
empty
Intervention groups
1
Description
In this study, 10 subjects walk on a path 13 meters long and 3 meters wide at their chosen speed. Information is provided by infrared cameras located in the laboratory environment that are sensitive to markers installed on the body. Each person will first perform the experiment with PLS orthosis, which covers the foot and ankle area and shoes without rollers, then rest for 10 minutes and perform the experiment with PLS with roller shoes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan MS Association
Full name of responsible person
Masoud Rafiaei
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 4053
Email
ma.rafiaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 4053
Email
ma.rafiaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 4053
Email
ma.rafiaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 4053
Email
ma.rafiaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available