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Comparison of the effect of vibratory and non-vibratory orthosis on sensorimotor function in people with chronic ankle instability

Protocol summary

Study aim
Comparison of the effect of two types of vibrating and non-vibrating ankle orthosis on sensory-motor function in people with chronic ankle sprain after a 4 weeks of using the orthosis
Design
A clinical trial with a control group, with parallel groups, randomized, on 57 patients. Randomization will be used by 2, 4, and 6 blocks.
Settings and conduct
Muscle reaction time, posture control, and proprioception will be evaluated before the intervention and 4 weeks after receiving the ankle support. Measuring tools include surface electromyography, force plate, and biodex isokinetic. The place of the tests is the Sport Sciences Research Institute of Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: history of at least 1 ankle sprain; the primary sprain must have occurred at least 12 months prior to study participation; the sprain was accompanied by inflammatory symptoms (pain, swelling, etc.); sprain that leads to at least 1 day away from daily activities; the last injury must have occurred more than 3 months before participating in the study; feeling of emptying and ankle instability; at least 2 episodes of giving way in the 6 months prior to study participation; a score of less than 24 on the Cumberland Instability Instrument; have not received treatment in the last 3 months; age 18-60 years old. Exit criteria: history of previous surgeries on musculoskeletal structures (eg, bones, joint structures, nerves) in any lower limb; history of fracture in any of the lower limbs.
Intervention groups
This clinical trial includes an intervention group and a control group. In the intervention group, vibrating ankle orthosis is used. And in the control group, an ankle orthosis without vibration will be used.
Main outcome variables
Peroneus longus and brevis muscle reaction time; proprioception; posture control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181021041400N2
Registration date: 2023-02-20, 1401/12/01
Registration timing: prospective

Last update: 2023-02-20, 1401/12/01
Update count: 0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Behnam Hajiaghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
hajiaghaei.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-12, 1402/02/22
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vibratory and non-vibratory orthosis on sensorimotor function in people with chronic ankle instability
Public title
Comparison of the effects of two types of vibrating and non-vibrating ankle orthoses on balance, proprioception, and reaction time of ankle muscles in people with chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of at least 1 ankle sprain 1.1. The first sprain must have occurred at least 12 months prior to study participation. 1.2. The sprain is accompanied by inflammatory symptoms (pain, swelling, etc.). The last injury must have occurred more than 3 months before participating in the study. Feeling of emptying and ankle instability 2.1. At least 2 episodes of giving way in the 6 months prior to study participation. 2.2. A score of less than 24 on the Cumberland Instability Instrument Have not received treatment in the last 3 months. Age 60-18 years old
Exclusion criteria:
History of previous surgeries on musculoskeletal structures (eg, bones, joint structures, nerves) in any lower limb History of fracture in any lower limb Acute injury to musculoskeletal structures of other joints of the lower limb in Past 3 months that has affected joint integrity and function resulting in at least 1 day away from daily activity
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in blocks with 2, 4, and 6 blocks. Also, random concealment is done by using sealed opaque envelopes with a random sequence. the first randomization is created and based on the opaque envelope sample size. Random number cards are placed inside the envelope. Then the participants choose the envelopes.
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 Iran University of Medical Sciences
Street address
Next to the Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.IUMS.REC.1401.794

Health conditions studied

1

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

Primary outcomes

1

Description
Reaction time of peroneus longus and brevis muscle during external perturbation.
Timepoint
Before the start of the study and 4 weeks after using the orthosis.
Method of measurement
Surface electromyography 8 canals Myon brand

2

Description
Postural control
Timepoint
Before the start of the study and 4 weeks after using the orthosis
Method of measurement
Force plate AMTI, Germany

3

Description
Proprioception
Timepoint
Before the start of the study and 4 weeks after using the orthosis
Method of measurement
Biodex Multi-Joint Systems, Germany

Secondary outcomes

1

Description
Quality of life
Timepoint
Before starting and 4 weeks after using the orthosis
Method of measurement
Foot and Ankle Ability Measure (FAMM) questionnaire

Intervention groups

1

Description
Intervention group: Ankle orthosis with Vibration. This type of orthosis consists of a supporting part and a vibrating part. Its supporting part is made of neoprene and thermoplastic and covers up to 10 centimeters above the wrist. The vibration section also consists of vibration motors. This vibration will be applied to the outer part of the ankle. The vibration frequency will be 100 Hz. Each participant will wear the orthosis for 6 hours per day for 4 weeks, but will only receive vibration for 30 minutes while walking.
Category
Rehabilitation

2

Description
Control group: Ankle orthosis without Vibration.This type of orthosis is made of only one supporting part. The supporting part is made of neoprene and thermoplastic and covers up to 10 centimeters above the wrist. Each participant will wear this orthosis for 6 hours every day for 4 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation Sciences , Iran University of Medical Sciences
Full name of responsible person
Behnam Hajiaghaei
Street address
Iran University of Medical Sciences, Faculty of Rehabilitatiion scinces, ShahNazari St, Mother Sq, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
hajiaghaei.b@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvan
Street address
Next to the Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Ashkar
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Orthotics and prosthetics
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation scinces, ShahNazari St, Mother Sq, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 0947
Fax
Email
Ashkar.Maryam42@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnam Hajiaghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and Prosthesis
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation scinces, ShahNazari St, Mother Sq, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 0947
Email
Hajiaghaei@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnam Hajiaghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation scinces, ShahNazari St, Mother Sq, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 0947
Email
Hajiaghaei.B@iums.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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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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