The effect of foot intrinsic muscles strengthening on postural control in subjects with functional ankle instability
Design
The study will be a clinical trial type with 3 groups of control, routine and intrinsic muscles, single blinded, randomized by permutation blocks method on 50 patients.
Settings and conduct
This study will be conducted on volunteer patients with functional ankle instability in Zahedan, Razmjoo moghaddam physiotherapy clinic of university of medical sciences. Patients will be entered randomly to one of the control, routine or intrinsic muscles groups. The patients will only be informed of their group.
Participants/Inclusion and exclusion criteria
Entry criteria:
1) Ladies and gentlemen aged 18-45 years
2) Unilateral functional ankle instability with at least one sprain in 1 recent year and feeling recurrent giving way
3) Not being mechanical instability in unstable ankle with doing anterior drawer test and talar tilt test
4) Not existing fracture, dislocation and structural disorders in lower limb
5) Not existing vertigo, faint and head trauma
6) No ankle injury in the last 3 months
No entry criteria:
1) Receive other treatment
2) Unwillingness to enter research
3) Taking painkillers, sedatives and alcohol
Intervention groups
The study consists of three groups of intrinsic muscles exercises, routine exercises and control group. In routine group, routine physiotherapy exercises in functional ankle instability and in intrinsic muscles strengthening group, special exercises of this muscles will be performed in 12 sessions for 4 weeks every other day. The control group will not be received any intervention.
Main outcome variables
Dynamic balance index for single leg and double legs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040466N2
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Fateme Ghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6708
Email address
f_ghiasi_p@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot intrinsic muscles strengthening on postural control in subjects with functional ankle instability
Public title
The effect of physiotherapy in functional ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral functional ankle instability with at least one sprain in recent year and recurrent giving way
Not being mechanical instability in unstable ankle with doing anterior drawer test and talar tilt test
Not existing fracture, dislocation and structural disorders in lower limb
Not existing vertigo, faint and head trauma
No ankle injury in the last 3 months
Exclusion criteria:
Receive other treatment
Unwillingness to enter research
Taking painkillers, sedatives and alcohol
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by available sampling method. then by randomization permutation blocks method will enter the groups:
A: intrinsic exercises group B: routine exercises group C: control group
In this method, after determining the age and sex, patients will enter the research in the following order:
CCCBBAA ABCABB ACCABCAA ACBCCAB BCACABA CCAABA CCABCBB BBCAABBCCBAB
According to this randomization, for example patient number 1 will enter group C and patient number 4 will enter group B and so on it will continue.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are considered blind regardless of the difference in treatment methods of the groups. In this research, patient will be blinded from other research groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.ZAUMS.REC.1398.174
Health conditions studied
1
Description of health condition studied
functional ankle instability
ICD-10 code
S93.40
ICD-10 code description
Sprain of unspecified ligament of ankle
Primary outcomes
1
Description
Dynamic balance indexes for single leg
Timepoint
The beginning of research and after of 4 week intervention
Method of measurement
Biodex system
2
Description
Dynamic balance indexes for double legs
Timepoint
The beginning of research and after of 4 week intervention
Method of measurement
Biodex system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The patient will perform foot intrinsic muscles exercises for 12 sessions. Patients in intrinsic muscles exercise group will perform the following exercises: scrunching towel with toes: the patient sitting on a chair, then puts his foot on top a towel and with toes flexion scrunches the towel. By putting weight at the end of the towel will progress the exercise. Short foot exercise: While the patient sitting on a chair, increase and decrease medial longitudinal arch. By doing in standing position, the exercise is progressed. Toes abduction and adduction: while sitting on a chair, the patient abduct and adduct the toes. By using elastic band, exercise is progressed. Piano key exercise: while sitting on a chair, alternately extend toes and big toe. Stretching big toe: in sitting position, he stretches his big toe toward extension. Passive exercises include mobilization of sub talar, midfoot and forefoot joints. These techniques are performed according to Maitland method. Exercises are done 3 sets with 10 repetitions. There is 30-60 seconds rest between each set. Exercises are conducted in physiotherapy clinic 3 times per week for 4 weeks.
Category
Rehabilitation
2
Description
Intervention group 2:The patient will perform routine exercises in functional ankle instability for 12 sessions. Patients in routine group will perform the following exercises: strengthening exercises with theraband for dorsi and plantar flexor muscles: in sitting position with extended knee, the exercise will be perform in both dorsi and plantar directions. Plantar flexor muscles stretching: in sitting position with extended knee, stretching is applied in the dorsi flexion direction with theraband or rope. Weight bearing on the heel and toe exercise: in standing position, the patient alternately shifts the weight on the heel and toe. Tilt board balance exercise: the patient preserves his balance on the affected foot on the tilt board. Leg reaches exercise: the sun is designed on the ground and then the patient stands on one foot in the middle point and moves the other foot in the directions of the sun's rays. This exercise will perform for both feet. Jump: the patient will practice jumping on the ground. Exercises will done 3 sets with 10 repetitions. There is 30-60 seconds rest between each set. Exercises are conducted in physiotherapy clinic 3 times per week for 4 weeks.
Category
Rehabilitation
3
Description
Control group: There is no intervention in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razmjo Moghadam Physiotherapy Clinic
Full name of responsible person
Mohammad Reza Arab Kangan
Street address
Razmejo Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3342 4675
Email
mohamadreza_arab@icloud.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Noormohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Dr.Hesabi sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
f_ghiasi_p@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
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