Protocol summary

Study aim
the effect of combined vibrational-tensile training on spasticity of lower extremity flexors and risk of multiple sclerosis.
Design
Clinical Trial with Control Group and Two Intervention Groups, 17 Patients were Selected as a Sample, and were Randomly Divided into Two Groups. The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Random Allocation Software was used to Create a Random Sequence. Then, for not Clearing that People Assigning to which Group before Allocated in other Words Allocation Concealment, was used as a Central Randomization Method.
Settings and conduct
This Research was a Quasi-experimental Study with Pre-test and Post-test Desing in Ahvaz City. 17 Patients were Selected as a Sample, and were Randomly Divided into Two Groups. Spasticity Measured by the Ashworth Modified Scale (MAS) and Fall Risk Measured by International Fall-I Risk Scale (FES-I).
Participants/Inclusion and exclusion criteria
In this study, patients with multiple sclerosis were able to walk without auxiliary tools, at least six months past their MS disease, with primary progressive MS, with no history of cardiovascular disease, epilepsy, metabolic disease, depression, anxiety, and Other psychiatric disorders, the presence of orthopedic diseases, a history of balance disorder and recurrent postural vertigo, severe pain in the lower extremity and trunk joints, vestibular disease, and visual impairment were all included with the diagnosis of a specialist physician
Intervention groups
Vibration and Combined Vibrational-Tensile Exercises
Main outcome variables
Spasticity of Lower Limb Flexors, Fall Risk

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200327046878N1
Registration date: 2020-08-16, 1399/05/26
Registration timing: retrospective

Last update: 2020-08-16, 1399/05/26
Update count: 0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Ahmad Saadi
Name of organization / entity
Raja University of Qazvin
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 4974
Email address
ahmadsaadi526@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
2017-12-06, 1396/09/15
Actual recruitment end date
2018-03-01, 1396/12/10
Trial completion date
2018-07-06, 1397/04/15
Scientific title
The Effect of Combined Vibration-Stretching Exercises on Spasticity of Lower Limb Flexors and Fall Risk in Patients with Multiple Sclerosis
Public title
The Effect of Combined Vibration-Stretching Exercises Patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having MS disease with EDSS index of 2 to 4 Male gender least six months have passed since the illness Able to walk without auxiliary tools 50 to 20 years of age
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 67
Actual sample size reached: 17
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Random Allocation Software was used to Create a Random Sequence. Then, for not Clearing that People Assigning to which Group before Allocated in other Words Allocation Concealment, was used as a Central Randomization Method.
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 Sport Sciences Research Institute of Iran
Street address
Sport Sciences Research Institute of Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.SSRC.REC.1399.043

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis (MS), is an autoimmune disease that affects the nervous symptom, launching an attack on its own tissue. Multiple sclerosis can range from relatively benign to somewhat disabling to devastating, as communication between the brain and oth

Primary outcomes

1

Description
spasticity of Lower limb flexors
Timepoint
Before intervention and mid-week of intervention and post-test
Method of measurement
Modified Ashworth Scale

Secondary outcomes

1

Description
Fall Risk
Timepoint
Before intervention and mid-week of intervention and post-test
Method of measurement
International Fall-I Danger Scale (FES-I)

Intervention groups

1

Description
Intervention Group 1: Vibration Exercises for 8 Weeks, 3 Sessions per Week
Category
Rehabilitation

2

Description
Intervention Group 2: Combined Vibration-Stretching Exercises for 8 Weeks, 3 Sessions per Week
Category
Rehabilitation

3

Description
Control Group: Without any Training and just doing normal Daily Activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jundishapur University of Medical Sciences Faculty of Rehabilitation
Full name of responsible person
Dariush Armat
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6155794963
Phone
+98 61 3337 4974
Email
Ahmadsaadi526@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja University
Full name of responsible person
Hadi Miri
Street address
Novrizian, Motahhari Blvd
City
Qazvin
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
hd.miri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raja University
Proportion provided by this source
10
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Raja University of Qazvin
Full name of responsible person
Ahmad Saadi
Position
Masters
Latest degree
Master
Other areas of specialty/work
Sport injuri
Street address
Kianabad Street 32 ​​West
City
Ahvaz
Province
Khouzestan
Postal code
6155794963
Phone
+98 61 3337 4974
Email
Ahmadsaadi526@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Raja University of Qazvin
Full name of responsible person
Ahmad Saadi
Position
Masters
Latest degree
Master
Other areas of specialty/work
Sport injuri
Street address
Kianabad Street 32 ​​West
City
Ahvaz
Province
Khouzestan
Postal code
6155794963
Phone
+98 61 3337 4974
Email
Ahmadsaadi526@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Raja University of Qazvin
Full name of responsible person
Ahmad Saadi
Position
Masters
Latest degree
Master
Other areas of specialty/work
Sport injuri
Street address
Kianabad Street 32 ​​West
City
Ahvaz
Province
Khouzestan
Postal code
6155794963
Phone
+98 61 3337 4974
Email
Ahmadsaadi526@gmail.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
Not applicable
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
Yes - There is a plan to make this available
Title and more details about the data/document
Only information about the data results available in the article can be shared
When the data will become available and for how long
When printing an article
To whom data/document is available
public
Under which criteria data/document could be used
If people have the same study or research
From where data/document is obtainable
ahmadsaadi526@gmail.com
What processes are involved for a request to access data/document
By Email: ahmadsaadi526@gmail.com and the Reason for Using the Documents
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