The efficacy of shoe inserts and ankle orthoses with vibrating components on ankle joint position sense and postural stability in subjects with functional ankle instability
The aim of this study is to evaluate the effectiveness of shoe inserts and ankle orthoses with vibratory components on joint position sense and postural stability in individuals with functional ankle instability
Design
This study is a randomized controlled trial with four parallel groups. A total of 32 samples are selected. Participants enter each of the study groups (n=8) through the blocked randomization method.
Settings and conduct
The location for sampling and construction of interventions will be the Technical Orthopedic Clinic of the Rehabilitation School of Medical University of Isfahan. After people are assigned to one of the four study groups using block randomization, evaluations are conducted before, immediately after, and two weeks after receiving the intervention. The location for the evaluations will be the Musculoskeletal Research Center of Isfahan University of Medical Sciences. These evaluations include slope box, one-leg stand on force plate, star excursion balance, and six-meter hop tests.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with a history of repeated ankle sprains who report a feeling of giving way and instability in the ankle joint will be included.
Exclusion criteria: People who have a history of musculoskeletal injuries, except ankle sprains in the lower limbs, are not included.
Intervention groups
1- Functional ankle instability patients who will receive ankle orthoses with vibratory components
2- Functional ankle instability patients who will receive ankle orthoses
3- Functional ankle instability patients who will receive shoe inserts with vibratory components
4- Functional ankle instability patients who will receive shoe inserts
Main outcome variables
Number of errors in slope box test, center of pressure excursion in single leg stance, reach distance of star excursion balance test, and time of six meter hop test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061793N1
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Hanieh Khaliliyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5014
Email address
haniehkhaliliyan@rehab.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of shoe inserts and ankle orthoses with vibrating components on ankle joint position sense and postural stability in subjects with functional ankle instability
Public title
Effect of vibratory orthoses in treatments of functional ankle instability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The individuals must have at least one significant ankle sprain that had occurred 12 months or more prior to the study, with continuing feeling of instability and/or ankle giving way
Acquire a score of less than 24 from Cumberland Ankle Instability Tool (CAIT)
Acquire a score less than 90% of possible score from activity of daily living subscale of Foot and Ankle Ability measure (FAAM) questionnaire
Acquire a score less than 80% of possible score from sport subscale of Foot and Ankle Ability measure (FAAM) questionnaire
Exclusion criteria:
History of disease that disturb balance
Taking medications that affect balance
History of lower limb musculoskeletal injury
History of lower limb fracture
History of lower limb surgery
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:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, the samples will be selected using available sampling and then assigned to one of the four groups (the shoe insert group, the ankle orthoses group, the shoe inserts with vibratory components group, or the ankle orthosis with vibratory components group) using the block randomization method. The randomization unit is individual. An equal number of participants will be assigned to each study group, following a 1:1:1:1 ratio. To create a random sequence of blocks, a code is assigned to each group, and the randomizer.org website is used. The entry order of participants is determined using eight blocks of size four. Once individuals meet the inclusion criteria and sign the consent form to participate in the study, they will be assigned to one of the groups based on the randomly selected block sequence.
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 committee of Isfahan university of medical sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-05-14, 1403/02/25
Ethics committee reference number
IR.MUI.NUREMA.REC.1403.029
Health conditions studied
1
Description of health condition studied
Functional ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot
Primary outcomes
1
Description
The reach distance of the star excursion balance test
Timepoint
Before, immediately after, and two weeks after wearing the orthoses
Method of measurement
The star excursion balance test
Secondary outcomes
1
Description
Time of the six meter hop test
Timepoint
Before, immediately after, and two weeks after wearing the orthoses
Method of measurement
The six meter hop test
2
Description
Center of pressure excursion in the single-leg stance test on the force plate
Timepoint
Before, immediately after, and two weeks after wearing the orthoses
Method of measurement
Single leg stance on force plate (force plate: model 9260AA6 with 600×500×50 mm dimensions)
3
Description
The number of errors in the slope box test
Timepoint
Before, immediately after, and two weeks after wearing the orthoses
Method of measurement
Slope box
Intervention groups
1
Description
Intervention group1: This group will receive an ankle orthosis with vibratory components. The orthosis is made of soft neoprene material and is fitted by an orthotist according to the size of the patient's ankle joint. It covers the lower third of the leg, the talocrural joint, and the joints in the foot up to the metatarsophalangeal joint. This orthosis will also have three coin vibration motors at the anterior, posterior, and inferior sides of the lateral malleolus.
Category
Treatment - Devices
2
Description
Comparison group1: This group will receive an ankle orthosis. The orthosis is made of soft neoprene material and is fitted by an orthotist according to the size of the patient's ankle joint. It covers the lower third of the leg, the talocrural joint, and the joints in the foot up to the metatarsophalangeal joint.
Category
Treatment - Devices
3
Description
Intervention group 2: This group will receive the shoe insert with vibratory components. This orthosis shell is prefabricated and will consist of three main parts: the base sole, the medial longitudinal arch support with a height of 15 mm, and the heel cup (made of foam with A50 hardness). The sole is full length and covers from the heel to the end of the toes. The shoe insert with vibratory components is fitted by an orthotist for patients based on the measurements of the foot (toe and heel width, foot length, and medial longitudinal arch length). In this orthosis, coin vibration motors will be placed under the head of the 1st and 5th metatarsals and the heel.
Category
Treatment - Devices
4
Description
Comparison group 2: This group will receive the shoe insert. This orthosis shell is prefabricated and will consist of three main parts: the base sole, the medial longitudinal arch support with a height of 15 mm, and the heel cup (made of foam with A50 hardness). The sole is full length and covers from the heel to the end of the toes. This orthosis is fitted by an orthotist for patients based on the measurements of the foot (toe and heel width, foot length, and medial longitudinal arch length).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Technical orthopedic clinic of rehabilitation school, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Pol
Street address
Technical orthopedic clinic of rehabilitation school, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5096
Email
haniehkhaliliyan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza askari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi-Demneh
Position
Professor and Faculty Member of the Department of Orthosis and Prosthesis
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and prosthetics
Street address
School of Rehabilitation, Esfahan University of Medical Sciences, Hezar Jerib St., Esfahan.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5018
Email
sadeghi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi-Demneh
Position
Professor and Faculty Member of the Department of Orthosis and Prosthesis
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and prosthetics
Street address
School of Rehabilitation, Esfahan University of Medical Sciences, Hezar Jerib St., Esfahan.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5018
Email
sadeghi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi-Demneh
Position
Professor and Faculty Member of the Department of Orthosis and Prosthesis
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and prosthetics
Street address
School of Rehabilitation, Esfahan University of Medical Sciences, Hezar Jerib St., Esfahan.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5018
Email
sadeghi@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study information (data related to the scores of the star excursion balance test, the six-meter hop test, the one-leg stand test on the force plate, and the slop box test) will be shared with other researchers.
When the data will become available and for how long
Information is shared after the results are printed or summarized.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
By performing statistical tests on the data, the applicants can evaluate the results of using the interventions of this study on the postural stability and the ankle joint position sense and use these data to conduct meta-analysis review studies.
From where data/document is obtainable
Individuals can request information from the person in charge.
What processes are involved for a request to access data/document
Requests should be sent to Dr. Ebrahim Sadeghi via email (sadeghi@rehab.mui.ac.ir).