Comparison the effects of combined mechanism ankle support, neoprene ankle support and custom made insole on dynamic balance of patient with chronic ankle instability
Comparison of the effect of combined ankle support, neoprene ankle support and custom made insole on dynamic balance of individuals with ankle instability
Design
Quasi-experimental and cross-sectional
In this study 22 eligible subjects with chronic ankle instability would be selected based on convenience sampling method and the immediate effect of orthoses on their balance would be evaluated
Settings and conduct
In this study, by using a star excursion balance test in a biomechanical laboratory, the effect of three types of orthoses on the balance of patients with chronic ankle instability would be evaluated. In this regard, the subjects would be investigated in 4 conditions; without orthosis, with combined ankle support, with neoprene ankle support and with custom made insole. The order of evaluation of orthoses would be selected randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria
-at least one significant ankle sprain
-continuing feeling of instability and/or ankle giving way
-acquire a score of <24 from Cumberland Ankle Instability Tool
acquire a score less than 90% of possible score from activities of daily living subscale, of Foot and Ankle Ability Measure (FAAM)
acquire a score less than 80% of possible score from sport subscale of Foot and Ankle Ability Measure (FAAM)
Exclusion criteria
-History of diseases that ِdisturb balance
-Taking medications that affect the balance
-History of musculoskeletal disorders
-history of fracture in lower extremity or acute injury to musculoskeletal -structures of the lower extremity
-history of previous surgeries to the musculoskeletal structures of the lower extremity
Intervention groups
Combined ankle support, Neoprene ankle support and Custom made insole
Main outcome variables
Dynamic balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037576N1
Registration date:2018-01-22, 1396/11/02
Registration timing:retrospective
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Mohammad Hadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
hadadim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of combined mechanism ankle support, neoprene ankle support and custom made insole on dynamic balance of patient with chronic ankle instability
Public title
Comparison the effect of ankle orthoses on balance of patient with ankle instability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
at least one significant ankle sprain
continuing feeling of instability and/or ankle giving way
acquire a score of <24 from Cumberland Ankle Instability Tool
acquire a score less than 90% of possible score from activities of daily living subscale, of Foot and Ankle Ability Measure (FAAM)
acquire a score less than 80% of possible score from sport subscale of Foot and Ankle Ability Measure (FAAM)
Exclusion criteria:
History of diseases that ِdisturb balance
Taking medications that affect the balance
History of musculoskeletal disorders
history of fracture in lower extremity or acute injury in musculoskeletal structures of the lower extremity
history of previous surgeries in the musculoskeletal structures of the lower extremity
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Actual sample size reached:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences ethics committee
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
shiraz
Province
Fars
Postal code
71345-1733
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.SUMS.REC.1396.113
Health conditions studied
1
Description of health condition studied
chronic ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot
Primary outcomes
1
Description
Dynamic balance with star excursion balance test
Timepoint
Before and after wearing the orthoses
Method of measurement
With star excursion balance test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, each person would be evaluated in four condition; without orthosis (as control), with combined ankle support, neoprene ankle support and custom made insole.
Category
Treatment - Devices
2
Description
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of medical sciences
Full name of responsible person
Mohammad Hadadi
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.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