Protocol summary

Summary
Objective: The aim of this study is to assess the effect of joint mobilization on dynamic postural control in subjects with chronic ankle sprain Design: Randomised placebo-controlled trial with concealed allocation, and patient blinding. Setting and product: Thirty subjects (male and female) aged between 20 to 35 years with chronic ankle sprain will be divided in two groups randomly. Major Inclusion and Exclusion criteria: patients have to experience minimum one time ankle sprain more than six weeks ago, repetitive ankle giving way during past 12 months, no experience of balance exercises, and no neurological and infection problem and ankle fracture. Intervention: The first group will be given an anterior-posterior Talar glide for 6 sessions with 40 glides each day. The control group will be given the imitated placebo mobilization during 6 sessions without applying any manual technique. Outcome measures: Y Balance Test will be used to assess the dynamic postural control of subjects at the beginning and the end of the treatment program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021324149N23
Registration date: 2016-09-27, 1395/07/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-27, 1395/07/06
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Talocrural joint mobilization on dynamic postural control in young athletes with chronic lateral ankle sprain.
Public title
The effect of joint mobilization on balance of athletes with chronic ankle sprain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Minimum one time ankle sprain more than six weeks ago; repetitive ankle giving way during past 12 months; no experience of balance exercises. Exclusion criteria: Neuromuscular and vestibular disorders; Fracture in Lower limbs; Middle ear infection; Upper respiratory tract infection; Common cold during study.
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Zand boulevard
City
Shiraz
Postal code
Approval date
2012-03-06, 1390/12/16
Ethics committee reference number
ct-90-3452

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- calcaneofibular (ligament), Deltoid(ligament), Internal collateral(ligament), Talofibular(ligament), Tibofibular(ligament), distal

Primary outcomes

1

Description
Balance
Timepoint
Before and After treatment
Method of measurement
Y balance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Anterior-posterior ankle mobilization, grade III for 6 sessions, with 40 repetition.
Category
Treatment - Other

2

Description
Control group: placebo mobilization during 6 sessions without applying any manual technique.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers under supervision of Shiraz university of Medical Sciences
Full name of responsible person
Dr. Fahimeh Kamali
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Dr. Saied Basir Hashemi
Street address
Karim khan boulevard
City
Shiraz
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, Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Dr. Fahimeh Kamali
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Fahimeh Kamali
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for updating data

Contact

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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