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Comparison the effect of the combination of whole body vibration and blood flow restriction with whole body vibration alone on balance, muscle strength, joint position sense and lower limb function in patients with chronic ankle instability

Protocol summary

Study aim
Comparison the effect of the combination of whole body vibration and blood flow restriction with whole body vibration alone on balance, muscle strength, joint position sense, lower limb function and functional limitations in patients with chronic ankle instability
Design
A randomized, double blind, controlled clinical trial with a factorial group design of 48 patients. The method of random allocation is the permuted block randomization method with a block size of six, which is done by using statistical software.
Settings and conduct
The intervention groups receive their interventions in 12 sessions in the Shiraz Faculty of Rehabilitation Sciences Clinic. Assessor physiotherapist and statistician are unware of the allocation of participants to groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria are as follows: a history of at least one ankle sprain; a history of giving way and / or recurrent sprain in ankle joint; feeling of ankle joint instability; and age between 18 and 50 years old. The exclusion criteria are as follows: history of previous surgery in the musculoskeletal system or fracture in one or both lower limbs; acute injury to other lower limb joints; contraindications of whole body vibration and blood flow restriction; severe deformities of the spine and lower limbs; any peripheral and central nervous disease; middle ear diseases; rheumatic diseases.
Intervention groups
The whole body vibration group receives its intervention using a whole body vibration device, the whole body vibration with blood flow restriction group receives the same program as whole body vibration group simultaneously with a blood flow restriction device and the control group does not receive any intervention between the initial and final assessment.
Main outcome variables
balance; muscle strength; joint position sense; lower limb function; functional limitations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240414061483N1
Registration date: 2024-05-10, 1403/02/21
Registration timing: prospective

Last update: 2024-05-10, 1403/02/21
Update count: 0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Maryam Salehooni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3622 4089
Email address
maryam.salehooni95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of the combination of whole body vibration and blood flow restriction with whole body vibration alone on balance, muscle strength, joint position sense and lower limb function in patients with chronic ankle instability
Public title
The effect of adding blood flow restriction to whole body vibration in the treatment of chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A history of at least one ankle sprain, the first of which occurred at least 12 months ago, was accompanied by inflammatory symptoms (pain, swelling, etc.), disrupted the patient's normal physical activity for at least one day, and more than 3 months had passed since the last time A history of giving way and / or recurrent sprain in a previously injured ankle joint. Participants had to report at least 2 episodes of ankle sprain in the past 6 months Feeling of ankle joint instability. Regarding the person's feeling of instability of the ankle joint, if the score is less than 24 in the CAIT questionnaire, the score is less than 90% in the activities of daily living section, and the score is less than 80% in the sport activities section of the FAAM questionnaire, the patient enters the study People who are between 18 and 50 years old
Exclusion criteria:
History of previous surgery in the musculoskeletal system in one or both lower limbs History of fracture in one or both lower limbs Acute injury to other lower limb joints in the past 3 months that has disrupted the patient's normal physical activity for at least one day Contraindications of whole body vibration (pregnancy, acute bleeding, pacemaker, cardiovascular diseases, tumors, hip and knee implants, acute herniation of intervertebral discs, diabetes, and kidney stone) Contraindications of blood flow restriction (poor circulatory system, obesity, diabetes, arterial calcification, high blood pressure, kidney disorders, venous thromboembolism, peripheral vascular damage, sickle cell anemia, limb infection, lymphadenectomy, cancer or tumor, and medications that increase the risk of blood clots) Severe deformities of the spine and lower limbs Any peripheral and central nervous disease Middle ear diseases Rheumatic diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation is the permuted block randomization method with a block size of six. Participants are randomly assigned with a ratio of 1:1:1 in one of the following three groups by using statistical software: whole body vibration, whole body vibration with blood flow restriction, and control. This is done by a person who is not involved in assessment and treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Assessment and treatment are done separately by two physiotherapists, and the assessor physiotherapist is unware of the participants' treatment. Statistical analysis is performed by a statistician who is unware of the allocation of participants to groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.SUMS.REHAB.REC.1403.002

Health conditions studied

1

Description of health condition studied
Chronic ankle instability
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Balance
Timepoint
At the beginning of the study (before the start of the intervention) and 4 and 8 weeks after the start of the intervention
Method of measurement
Balance is evaluated using the modified Star Excursion Balance Test. This test is a modified and simplified version of the Star Excursion Balance Test that uses three directions: anterior, posterior-medial, and posterior-lateral. These three directions are marked by adhesive tapes on the floor. In this way, the angle between the anterior line and the posterior-medial line is 135 degrees, the angle between the anterior line and the posterior-lateral line is 135 degrees, and the angle between the posterior-medial line and the posterior-lateral line is 90 degrees. All participants stand without shoes and with their eyes open on the injured foot, with the big toe placed in the center of these three lines, and hands on their thighs. The participants with their good foot along each path touch the greatest distance they can with their big toe and the place where the big toe of the good foot touches the ground is marked and recorded by the examiner. Then, maintaining balance, the patient returns to the starting position, which is standing on two legs. They do this first in the anterior path, then in the posterior-medial path and finally in the posterior-lateral path. The contact of a healthy foot with the ground should be gentle and without bearing weight on it. For each route, the participants do 3 times of training and then rest for 5 minutes and then do the main test 3 times and 10 seconds of rest between each route is considered in the main test. The distance from the center of these three lines to the point of contact of the big toe of the healthy foot is measured in centimeters in each direction, and the average of the 3 main test times in each direction is calculated and the length of the person's lower limb (from the anterior-superior iliac spine to the inferior border of medial malleolus) is normalized and multiplied by 100 and used for statistical analysis. If the involved leg that is in the center moves or lifts off the ground, the healthy leg does not return to the starting point or is used to bear weight and the hands are removed from the thighs, the test is not accepted and must be repeated.

2

Description
Muscle strength
Timepoint
At the beginning of the study (before the start of the intervention) and 4 weeks after the start of the intervention
Method of measurement
The concentric and eccentric strength of ankle invertor and evertor muscles is evaluated using an isokinetic device (Biodex System 4 pro, Biodex Medical System Inc., Shirley, New York). Participants sit on the chair of the machine while the back of the chair is placed at an angle of 70 degrees, the involved lower limb is placed on the special connecting rod of the machine, the involved ankle is in a normal position, and the axis of the ankle joint is aligned with the machine axis. The trunk and lower limb of the person are fixed with a belt. In order to familiarize the person with how the device works, the participants perform three sub-maximal contractions of the invertor and evertor muscles of the ankle at a speed of 90 degrees per second and within a range of motion of 40 degrees (15 degrees of eversion to 25 degrees of inversion). To minimize learning, the order of inversion and eversion movements is done randomly. After 2 minutes of rest, the person performs three maximum contractions of the invertor and evertor muscles of the ankle, and 15 seconds rest is taken between each time, and visual and auditory feedback is given to the participants to perform the maximum contraction. The maximum torque of ankle invertor and evertor muscles strength is normalized to the individual's body weight and used for statistical analysis. Also, the E/I ratio is calculated by using the amount of concentric strength of the ankle evertor muscles to the amount of eccentric strength of the ankle invertor muscles for maximum torque. This ratio expresses the concentric contraction of the ankle evertor muscles to counter the strong inversion mechanism in the open chain of motion and/or the eccentric contraction of the ankle invertor muscles to control the external displacement of the tibia in the closed chain of motion. This ratio is also used for statistical analysis.

Secondary outcomes

1

Description
Joint position sense
Timepoint
At the beginning of the study (before the start of the intervention) and 4 weeks after the start of the intervention
Method of measurement
Active joint position sense is assessed using an isokinetic device (Biodex System 4 pro, Biodex Medical System Inc., Shirley, New York). Participants sit on the chair of the machine while the back of the chair is placed at an angle of 70 degrees, the involved lower limb is placed on the special connecting rod of the machine, the involved ankle is in a normal position, and the axis of the ankle joint is aligned with the machine axis. The person's trunk and lower limb are fixed with a belt, and the person's eyes are closed with a blindfold. The active sense of joint position is evaluated in two positions of 15 degrees of inversion and 10 degrees of eversion at a speed of 5 degrees per second. First, the involved ankle is placed in a neutral position. Then the device randomly places the person's ankle in the reference angle of inversion or eversion for 10 seconds and the person is asked to remember the angle. Then the device returns the person's ankle to the neutral position and the person is asked to actively reproduce the angle 3 times and the corresponding angles are recorded. The mean absolute error is used for statistical analysis.

2

Description
Lower limb function
Timepoint
At the beginning of the study (before the start of the intervention) and 4 and 8 weeks after the start of the intervention
Method of measurement
Lower limb function is evaluated using the triple Hop test. A tape is drawn on the ground, perpendicular to the starting line. Participants stand on the involved foot while wearing athletic shoes, with the big toe on the starting line and their healthy foot in flexion without contact with the involved foot. Participants perform 3 maximum forward jumps while arm swing is allowed. If the person can land in a controlled and stable manner, the test is considered successful. To get familiar with the test, the participants first do 1-3 times of practice and then 3 times of the main test. If the participant can not perform the jump without losing balance and touching the ground with the healthy leg, the test is repeated. The distance of the jump from the starting point to the correct contact point of the heel with the ground is recorded in centimeters. The maximum jump distance is used for statistical analysis.

3

Description
Functional limitations
Timepoint
At the beginning of the study (before the start of the intervention) and 4 and 8 weeks after the start of the intervention
Method of measurement
Functional limitations is evaluated using the Foot and Ankle Ability Measure questionnaire. This questionnaire contains 29 questions with 6 options, which are placed in two sections: activities of daily living with 21 questions and sports activities with 8 questions. In each question, the option that best describes the patient's condition is selected by the patient. Each question is scored from 0 to 4 based on the option chosen by the patient, and the total score is reported as a percentage.

Intervention groups

1

Description
The first intervention group (whole body vibration group): participants who are in this group receive the intervention using the whole body vibration device (Fitvibexcel pro, uniphy, ElektromedizinGmbH & Co. KG-Germany) during 12 sessions (3 sessions per week for a 4 consecutive weeks) in a progressive manner. Each session consists of 3 sets exercises and 45 seconds rest is considered between each set. Increasing the intensity of training is done by increasing the frequency and duration of each set during 12 sessions. The increase in frequency is from 30 Hz to 40 Hz in 12 sessions, so that in the first 4 sessions, the frequency is 30 Hz, in the second 4 sessions, the frequency is 35 Hz, and in the third 4 sessions, the frequency is 40 Hz. Also, the duration of each set is increased from 30 seconds to 60 seconds in 12 sessions, so that the duration of each set is 30 seconds in the first 4 sessions, 45 seconds in the second 4 sessions, and 60 seconds in the third 4 sessions to be. During the rest intervals between sets, the participants stand on the device turned off. Participants perform the exercise while standing on both feet. To localize the oscillations on the ankles and reduce their transfer to the trunk, the participants stand in a semi squat position (30 degrees of knees flexion) on the device and put the weight on the forefoot. In order to standardize the amount of knee flexion between sessions, the physiotherapist supervising the treatment sessions asked the participants to bend their knees as if they were about to sit down, with their knees not extending past their big toes. In case of dizziness and nausea, the treatment is stopped. It is possible for participants to stop the device by pressing the emergency stop button. In addition, to prevent a possible fall, the physiotherapist should stand behind the patient and provide the necessary support.
Category
Rehabilitation

2

Description
The second intervention group (whole body vibration with blood flow restriction group): participants perform the same whole body vibration group program simultaneously with a blood flow restriction device from Anhuma. An appropriately sized cuff is wrapped around the proximal thigh of the involved limb and inflated with a pressure equal to 80% of the arterial occlusion pressure of the posterior tibial artery of the involved limb in each subject. The arterial occlusion pressure of each person is the pressure required to completely block the blood flow. Every session before the start of the exercise, the person lies in the supine position for 5 minutes and this pressure is determined. The cuff pressure is maintained during the entire treatment session, including rest periods between sets, and the cuff is deflated after each session.
Category
Rehabilitation

3

Description
The control group: participants will not receive any intervention in the interval between the initial and final evaluation, and in order to be ethical in the research, a useful exercise program will be given to this group at the end of the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences Clinic located in Shahid Chamran Hospital
Full name of responsible person
Farzane Haghighat
Street address
Faculty of Rehabilitation Sciences Clinic, Mehr Oncology Palliative Care Center, Shahid Chamran Hospital, Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3212 2600
Fax
Email
Haghighat_fa@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadhashem Hashempur
Street address
7th Floor, Shiraz University of Medical Sciences central Building, Near Red Crescent, Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@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
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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahrari Shirazi
Position
Assistant Professor of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Fax
Email
SAhrari@Sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahrari Shirazi
Position
Assistant Professor of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Fax
Email
SAhrari@Sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahrari Shirazi
Position
Assistant Professor of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Fax
Email
SAhrari@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
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