Protocol summary

Study aim
Determination of motor cortex excitability changes following dynamic balance exercises
Design
A controlled, parallel-group, single-blind, randomized clinical trial of 38 patients. Permutation block randomization is used.
Settings and conduct
Study will be conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences, people with functional ankle instability randomly allocated in control and treatment groups. the evaluator will be blinded to allocation.
Participants/Inclusion and exclusion criteria
inclusion criteria: at least once unilateral ankle sprain with grade II in last 1-3 years at least twice giving way in injured ankle in last 6 months score ≤ 24 in CAIT questionnaire 20-60 years old exclusion criteria: Ankle joint laxity Moderate to severe pain and swelling in ankle severe limitation in ankle range of motion surgery or fracture in lower limbs neurovascular and musculoskeletal disorders in lower limbs taking any medicine in last 2 weeks before the study physical therapy in last 6 months before the study systemic diseases or rheumatological disorders Balance and vestibular disorder brain surgery and head trauma migraine and seizures metal or electric implant in body psychiatric disorders Pregnancy or breastfeeding
Intervention groups
Balance exercises on the involved leg in each session will be include two statics (3 sets of 30 seconds) and four dynamics (3 sets of 6 repetitions for posterior-anterior and medial-lateral tilts, 1 set of 10 repetitions for clockwise and counterclockwise rotations). Instability of static will be decrease from 11 and 7 in first week to 6 and 2 in sixth week, and in dynamic from 7 to 2. the control group will not receive balance exercises.
Main outcome variables
Cumberland ankle instability tools questionnaire score; motor evoked potential in rest and active state; cortical silence period

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221218056847N1
Registration date: 2023-01-10, 1401/10/20
Registration timing: prospective

Last update: 2023-01-10, 1401/10/20
Update count: 0
Registration date
2023-01-10, 1401/10/20
Registrant information
Name
mahdis purzolfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4268 4299
Email address
mahdispurzolfi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Changes in Corticomotor Excitability of the Peroneal Muscles in People with Functional Ankle Instability Received Dynamic Balance Exercise: A Randomized Clinical Trial
Public title
effect of balance training on excitability of brain motor cortex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least once unilateral ankle sprain with grade II in last one to three years, which is followed by symptoms of pain, swelling and temporary loss of function. giving way a in the injured ankle, at least 2 times in the last 6 months less than 24 score in the CAIT questionnaire 20 - 60 years old
Exclusion criteria:
ankle joint laxity Moderate to severe pain and swelling in the ankle Severe limitation of ankle range of motion surgery or fracture in the lower limbs neurovascular and musculoskeletal disorders in the lower limbs taking any medicine in last 2 weeks Participation in physical therapy in last 6 months systemic diseases or rheumatological disorders Balance and vestibular disorder brain surgery and head trauma of migraine and seizures metal or electric implant in body psychiatric disorders Pregnancy or breastfeeding
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method will be used for randomization. In this regard, blocks of four with numbers 1 to 6 will be used as follows: (in each block, a means the intervention group and b means the control group): 1-aabb 2-abba 3-abab 4-baba 5-baab 6-bbaa After choosing numbers one to six from the table of random numbers (numbers 0 and 7 to 9 are not taken into account), the block associated with each number is determined and the eligible people are enrolled in the study from left to right in each block and will be assigned in one of a or b group. The numbers will be selected nine times and the first 36 people will be grouped in this way, and the last two people will be entered into the group by assigning a coin. Participants, therapists, and evaluators will be unaware of the grouping. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans will be numbered based on a random sequence, and inside the boxes, the desired intervention will be given to the therapist with a sheet on which the random allocation is written, with the condition that the boxes are completely sealed and the therapist will assign patients to intervention and control groups based on the order of arrival.
Blinding (investigator's opinion)
Single blinded
Blinding description
A physiotherapist will be in charge of the treatment process of the intervention group, and another physiotherapist will evaluate the desired variables. Therefore, the future study will be a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Basij Blvd, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.SEMUMS.REC.1401.249

Health conditions studied

1

Description of health condition studied
functional ankle instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle

Primary outcomes

1

Description
motor evoked potential (MEP)
Timepoint
Before and After the Intervention
Method of measurement
Transcranial Magnetic Stimulation and surface EMG

2

Description
cortical silence period (CSP)
Timepoint
before and after treatment
Method of measurement
Transcranial Magnetic Stimulation and surface EMG

Secondary outcomes

1

Description
self-reported functional ankle instability
Timepoint
before and after treatment
Method of measurement
cumberland ankle instability tools questionnaire

Intervention groups

1

Description
Intervention group: The treatment in the interventiongroup (19 people) will include 18 session (6 weeks, 3 days per week, every other day) of static and dynamic balance exercises with biodex balance system. Balance exercises on the involved leg in each session will be include two statics (3 sets of 30 seconds) and four dynamics (3 sets of 6 repetitions for posterior-anterior and medial-lateral tilts, 1 set of 10 repetitions for clockwise and counterclockwise rotations). Instability of static exercises will be decrease from 11 and 7 in the first week to 6 and 2 in the sixth week, and in dynamic exercises from 7 to 2 (decreasing one degree per week).
Category
Treatment - Devices

2

Description
Control group: no therapeutic action is considered for this group and this group will be evaluated and compared with the intervention group at the beginning and end of the study in terms of motor cortex excitability.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Mahdis Purzolfi Khansari
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mahdispurzolfi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.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
Mahdis Purzolfi Khansari
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mahdispurzolfi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Cyrus Taghizadeh Delkhoush
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
cyrustaghizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahdis Purzolfi Khansari
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mahdispurzolfi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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