The Effects of Sensory Targeted Ankle Rehabilitation Strategies on Static and Dynamic Balance in Athletes with Chronic Ankle Instability
Design
Clinical trial with a control group, with parallel groups, one-way blind, randomized, on 51 patients (3 groups of 17 people).
Settings and conduct
This study will be conducted as a clinical trial at the Neuromuscular Rehabilitation Research Center in Semnan. The assessment will be carried out by two evaluators without knowing the nature of the evaluation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 45-18 years; At least 90 minutes of aerobic exercise or equivalent activity per week; Score higher than 4 in the Ankle Instability Instrument (AII).
Exclusion criteria: Acute ankle sprain within the last 6 weeks; Specific balance and vision problems; Acute lower limb problems and a history of lower limb surgery to correct or repair internal disorders; Head injury (in last 6 weeks).
Intervention groups
Intervention group 1: In this group, patients will perform progress-based balance exercises for 4 weeks (3 sessions of 20 minutes per week) according to the protocol.
Intervention group 2: In this group, patients will perform progress-based balance exercises for 4 weeks (3 sessions of 20 minutes per week) according to the protocol. Before each balance training session, they will receive a 5-minute set of sensory targeted ankle rehabilitation strategies treatments (leg muscle stretching, sole massage, ankle joint mobilization, and ankle joint stretching).
Control group: There is no intervention and it is only for comparison with the intervention group.
Main outcome variables
Static balance tests; Dynamic balance tests.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N71
Registration date:2022-04-17, 1401/01/28
Registration timing:registered_while_recruiting
Last update:2022-04-17, 1401/01/28
Update count:0
Registration date
2022-04-17, 1401/01/28
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Sensory Targeted Ankle Rehabilitation Strategies on Static and Dynamic Balance in Athletes with Chronic Ankle Instability
Public title
The Effects of Sensory Targeted Ankle Rehabilitation Strategies on Static and Dynamic Balance in Athletes with Chronic Ankle Instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-18 years
At least 90 minutes of aerobic exercise or equivalent activity per week
Score higher than 4 in the Ankle Instability Instrument (AII)
Exclusion criteria:
Acute ankle sprain within the last 6 weeks
Specific balance and vision problems
Acute lower limb problems and a history of lower limb surgery to correct or repair internal disorders
Head injury (in last 6 weeks)
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in ABC, ACB, BAC, BCA, CAB, and CBA using three blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 17 units of 3 blocks will be selected so that we consider having 17 people in the group (A), 17 people in the group (B) and 17 people in the group (C). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessment will be carried out by two evaluators without knowing the nature of the evaluation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-01-24, 1400/11/04
Ethics committee reference number
IR.SEMUMS.REC.1400.290
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
M12.07
ICD-10 code description
Chronic postrheumatic arthropathy [Jaccoud], ankle and foot
Primary outcomes
1
Description
Static balance tests
Timepoint
Before the intervention, 24 hours after the intervention and 1 month after the intervention.
Method of measurement
Biodex device
2
Description
Dynamic balance tests
Timepoint
Before the intervention, 24 hours after the intervention and 1 month after the intervention.
Method of measurement
Biodex device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients will perform progress-based balance exercises for 4 weeks (3 sessions of 20 minutes per week) according to the protocol.
Category
Treatment - Devices
2
Description
Intervention group 2: In this group, patients will perform progress-based balance exercises for 4 weeks (3 sessions of 20 minutes per week) according to the protocol. Before each balance training session, they will receive a 5-minute set of sensory targeted ankle rehabilitation strategies treatments (leg muscle stretching, sole massage, ankle joint mobilization, and ankle joint stretching).
Category
Treatment - Devices
3
Description
Control group: There is no intervention and it is only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Ziaeddin Safavi-Farokhi
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Shirmohamadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
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