To evaluate the effect of 1 and 12 sessions of vibration training on the displacement of the center of pressure in people with chronic ankle sprain while maintaining a standing balance that is simultaneously conducting a cognitive activity.
Design
A controlled clinical trial in the thirty two patients and healthy
Settings and conduct
This study will be carried out at the Neuromuscular Rehabilitation Center of Semnan University of Medical Sciences. In the intervention group, the static balance will be evaluated in the standing position on the affected ankle on the force plate. Then, an experienced physiotherapist will intervened patients for 12 sessions, 2 sessions per week for 6 weeks, via the whole body vibration. Training in each session consists of 3 series of 4-trials for 45-second with 45-second of rest between each trials. After the intervention in the first session and session 12, the balance will be evaluated. Healthy matched group according to the BMI and sex will be evaluated for the static balance.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. People with chronic ankle sprain who have had a history of at least 1 sprain over the past 2 years.
2. Having giving way for at least 2 times in the history of chronic ankle sprain
3-score 24 ≤ based on the Cumberland Ankle Instability Tool.
Exclusion criteria:
1. Neuromuscular disorders, ear and balance disorder, Addiction and consumption of psychoactive drugs
2. History of surgery and fractures of the lower limb and cardiovascular diseases
Intervention groups
The patients with chronic ankle sprain is placed in the intervention group and will be subjected to whole vibration for 12 sessions.
The control group, which will only evaluate the parameters of the displacement of the center of pressure.
Main outcome variables
The parameters of the center of pressure in standing position on the affected foot
General information
Reason for update
Acronym
WBV
IRCT registration information
IRCT registration number:IRCT20160808029264N3
Registration date:2019-02-28, 1397/12/09
Registration timing:registered_while_recruiting
Last update:2019-02-28, 1397/12/09
Update count:0
Registration date
2019-02-28, 1397/12/09
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
1919-04-22, 1298/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate and delayed effects of whole body vibration on the static balance during cognitive tasks in patients with chronic ankle sprain
Public title
The effect of whole body vibration on ankle sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. People with chronic ankle sprain who have had a history of at least 1 degree of torsion over the past 2 years.
2. Having at least 2 times the empty leg in the history of chronic ankle sprain
3-score of 24≤ based on the Cumberland Ankle Instability Tool
Exclusion criteria:
Memory impairment and neurological defects such as dementia, Parkinson's disease, brain trauma, encephalitis, dizziness and anemia, diabetes and ear disorder and addiction
History of surgery and fractures of the lower limb
History of cardiovascular disease
History of any disturbance affecting the balance system
use of psychoactive drugs
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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 Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951-35198
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.SEMUMS.REC.1397.267
Health conditions studied
1
Description of health condition studied
Chronic ankle sprain
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
Center of pressure displacement on the force plate in both patients and healthy groups
Timepoint
Before, immediately after sessions 1 and 12 and 1 times in healthy group
Method of measurement
Force plate
Secondary outcomes
1
Description
pain
Timepoint
Before and immediately after the 1th and 12th sessions
Method of measurement
A 100-mm numerical pain questionnaire
Intervention groups
1
Description
Intervention group: Whole body vibration for 12 sessions and 2 sessions per week for 6 weeks. 3sets of 4 repetition with 45 second hold and 45 second rest between trials will performed.
Category
Rehabilitation
2
Description
Control group: There will be no intervention in the healthy control group.In this group, everyone will be assessed once for the static balance.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Rehabilitation Clinic
Full name of responsible person
Rasool Bagheri
Street address
Next to Sepah Bank., 17 shahrivar Blvd., Semnan town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3344 1022
Email
rasool.bagheri@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Email
Rassol.bagheri@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Email
rasool.bagheri@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.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