Protocol summary

Summary
This study aimed to investigate the effect of six weeks of neuromuscular training on muscle strength, balance, range of motion and preconception in men with lateral ankle ligament sprains. This intervention study was a non-blinded clinical trial. The main inclusion criteria were: male patients with lateral ankle ligament sprains (grade I and II) in the dominant leg؛ injured within the last 6 months and ranging in age from 18 to 35 years who received routine physiotherapy when entering the study and had no pain and swelling. The exclusion criteria were: presence of other injuries in the lower extremities؛ damages affecting the balance (scoliosis and amputation), history of inner ear problems and vertigo؛ any kind of problem in the nervous system؛ problems with vision which were not corrected؛ age over 35 years and under 18 years؛ not completing the therapy sessions until the end of the 6th week for any reason and also the injured ankle not being in the dominant leg. A total of 17 male patients with lateral ankle ligament sprains performed neuromuscular training for six weeks and the effect of these exercises on muscle strength, balance, range of motion and preconception will be measured.

General information

Acronym
lateral ankle sprain
IRCT registration information
IRCT registration number: IRCT2014091619190N1
Registration date: 2014-12-17, 1393/09/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-17, 1393/09/26
Registrant information
Name
MohammadReza Karami
Name of organization / entity
University of Tehran international campus
Country
Iran (Islamic Republic of)
Phone
+98 912 815 0497
Email address
m.rezakarami69@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of University of Tehran Kish International Campus
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 6 weeks neuromuscular training on muscle strength, balance, range of motion & proprioceptive in males with lateral ankle sprain
Public title
Effect of 6 weeks neuromuscular training
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria were: male patients with lateral ankle ligament sprains (grade I and II) in the dominant leg؛ injured within the last 6 months and ranging in age from 18 to 35 years who received routine physiotherapy when entering the study and had no pain and swelling. The exclusion criteria were: presence of other injuries in the lower extremities؛ damages affecting the balance (scoliosis and amputation), history of inner ear problems and vertigo؛ any kind of problem in the nervous system؛ problems with vision which were not corrected؛ age over 35 years and under 18 years؛ not completing the therapy sessions until the end of the 6th week for any reason and also the injured ankle not being in the dominant leg.
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University Kish International Cumpus
Street address
Kish
City
Kish
Postal code
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
2302

Health conditions studied

1

Description of health condition studied
lateral ankle sprain
ICD-10 code
S93.4
ICD-10 code description
sprain and strain of ankle

Primary outcomes

1

Description
muscle strength
Timepoint
pretest , post test
Method of measurement
isokinetic machine

2

Description
proprioceptive
Timepoint
pretest , post test
Method of measurement
isokinetic machine

Secondary outcomes

1

Description
range of motion
Timepoint
pretest,posttest
Method of measurement
goniometer

2

Description
balance
Timepoint
pretest,posttest
Method of measurement
biodex balance system

Intervention groups

1

Description
exercise therapy, 6 weeks , 3 times a week , 45,60 min per time
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Farda physiotherapy clinic
Full name of responsible person
Dr. Yahya Sokhangoei
Street address
Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of University of Tehran Kish International Campus
Full name of responsible person
Dr.Rajabi
Street address
Kish
City
Kish
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of University of Tehran Kish International Campus
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Tehran Kish International Cumpus
Full name of responsible person
Mohammad Reza Karami
Position
Master student
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8841 9424
Fax
Email
rezakarami69@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University
Full name of responsible person
Dr. Nader Rahnema
Position
Professor
Other areas of specialty/work
Street address
Esfahan
City
Esfahan
Postal code
Phone
+98 31 3793 2195
Fax
Email
rahnemanader@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran Kish International Cumpus
Full name of responsible person
Mohammad Reza Karami
Position
Student
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8841 9424
Fax
Email
rezakarami69@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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