Protocol summary

Study aim
Explanation of the possible effects of local vibration of the soles of the feet on different systems affecting balance
Design
Before and after intervention study, one intervention group, 12 patients, sample size with non-parametric Wilcoxon test
Settings and conduct
first session Patients visit the clinic and fill in the consent form and information questionnaire, balance assessment by mini-best test, assessment of spasticity (MMAS) and plantar surface sensation (SWMF) and range of ankle dorsiflexion, recording of Hoffman's reflex, application of vibration for 5 minutes with 100 Hz frequency, 3 middle sessions of vibration application based on the patient's choice, it is done in the form of a home visit at home or a visit to the clinic in person, the last session (fifth) visit the clinic in person and apply vibration and repeat all the evaluations of the first session
Participants/Inclusion and exclusion criteria
Criteria for entering the study: ● Diagnosis of stroke by a neurologist ● At least 3 months have passed since the last stroke ● Suffering from stroke-induced balance disorder based on the one-leg standing test (the patient's inability to stand on the more involved leg for 30 seconds with eyes open) Criteria for not entering the study: People who were undergoing other treatments to improve balance The presence of any other neurological disease, other than stroke, that leads to balance deficits (such as Parkinson's and cerebellar injuries, etc.)
Intervention groups
The local vibration of the soles of the feet with a frequency of 100 was applied for 5 minutes and in 5 sessions every other day
Main outcome variables
Hmax/Mmax Hmax latency Minibest test score Severity of spasticity dorsiflexion ROM sense of plantar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221116056517N1
Registration date: 2023-04-17, 1402/01/28
Registration timing: retrospective

Last update: 2023-04-17, 1402/01/28
Update count: 0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
mahsa dastkhosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6534 5080
Email address
mahsadastkhosh75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-16, 1401/08/25
Expected recruitment end date
2022-12-14, 1401/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the clinical and electrophysiological mechanisms of the short term effects of local plantar vibration on balance in patients with chronic stroke(pilot study)
Public title
Studying the clinical and electrophysiological mechanisms of the short term effects of local plantar vibration on balance in patients with chronic stroke(pilot study)
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of stroke by a neurologist At least 3 months have passed since the last stroke Suffering from stroke-induced balance disorder based on the one-leg standing test (inability of the patient to stand on the more involved leg for 30 seconds with eyes open) Ability to stand and walk independently Ability to understand and follow instructions A person's body mass index should not be above the limit of 30
Exclusion criteria:
People who were undergoing other treatments to improve balance The presence of any other neurological disease, other than stroke, that leads to balance deficits (such as Parkinson's and cerebellar injuries, etc.) Lower extremity surgery within the past year Severe visual impairment (hemi anopia) and impairment of the vestibular-auditory system
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 12
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 Committee of Tehran University of Medical Sciences
Street address
No. 33 , West sajedin Alley., Ebnesina Ave., Dr Hesabi Ave., Phase5., Andisheh Town
City
Tehran
Province
Tehran
Postal code
1481946491
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
62033

Health conditions studied

1

Description of health condition studied
Chronic Brain Stroke
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hmax/Mmax
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after 5 intervention sessions)
Method of measurement
Electromyography

Secondary outcomes

1

Description
Balance
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after 5 intervention sessions)
Method of measurement
Minibest Test

Intervention groups

1

Description
Intervention group: local vibration of the soles of the feet with a frequency of 100 Hz for 5 minutes and in 5 sessions every other day is applied to both soles of the patient.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک کاردرمانی لیام
Full name of responsible person
Mohaddeseh Gorji
Street address
Royal Buildind., Basij Sq., Shahriyar Town
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6527 8892
Email
mahsadastkhosh75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soofia Naghdi
Street address
Pich-E-Shemiran., Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
mahsadastkhosh75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Sofia Naghdi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
naghdi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sofia Naghdi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
naghdi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Dastkhosh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
3354981267
Phone
+98 21 6534 5080
Email
mahsadastkhosh75@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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