Protocol summary

Summary
The aim of this study was to investigate the effects of the dual task training and balance training on balance indices in subjects with functional ankle instability. This randomized clinical trial was performed in Zahedan University of medical sciences, in 2015 2016. 32 Subjects with functional ankle instability were selected through non probability sampling method. The subjects were selected based on following inclusion criteria: Functional ankle instability with at least one ankle sprain in the last year and feeling the giving way, The absence of mechanical instability of ankle by performing the anterior drawer test and talar tilt test, history of dizziness and fainting, Pain or swelling in the ankle, Impaired vision or hearing or speech, hip and lower extremity musculoskeletal disorders, feeling any pain and discomfort in the body and age between 18 to 52 years. Exclusion criteria included: The reluctance of patients to continue treatment, worsening of symptoms during the study, another treatment during investigation, given the patient's lack of progress in the early stages of attention training. The subjects were randomly allocated to two groups: dual task training group and biodex balance training group. Each of the two the two groups received their interventions for 4 weeks and 3 sessions per week. Before and after the period of the interventions, overall, anteroposterior and mediolateral stability indices were measured through the postural stability test of biodex balance system.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604251675N13
Registration date: 2017-01-24, 1395/11/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Asghar Akbari
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1322 8445
Email address
akbaria@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Zahedan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-06, 1395/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dual task training on dynamic postural control in subjects with functional ankle instability
Public title
The effect of dual task training on postural control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 52; functional ankle instability with at least one ankle sprain in the last year and feeling the giving way; the absence of mechanical instability of ankle by performing the anterior drawer test and talar tilt test; no history of dizziness and fainting; pathological forgetfulness; pain or swelling in the ankle; hip and lower extremity musculoskeletal disorders; history of spinal trauma in the last six months; feeling any pain and discomfort in the body; history of pain and swelling in the body symmetrically; taking painkillers; sedatives and alcohol 48 hours before the test; history of head injury; impaired vision or hearing, or speech. Exclusion criteria: The reluctance of patients to continue treatment; worsening of symptoms during the study; another treatment during investigation; given the patient's lack of progress in the early stages of attention training.
Age
From 18 years old to 52 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Subjects were randomly assigned into two groups by random draw.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq. Zahedan
City
Zahedan
Postal code
9816843463
Approval date
2016-02-16, 1394/11/27
Ethics committee reference number
ir.zaums.rec.1394.375

Health conditions studied

1

Description of health condition studied
functional ankle instability
ICD-10 code
S93.4
ICD-10 code description
Sprain and Strain of Ankle

Primary outcomes

1

Description
Overall stability index
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex balance system

2

Description
Mediolateral stability index
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex balance system

3

Description
Anteroposterior stability index
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex balance system

Secondary outcomes

empty

Intervention groups

1

Description
Balance training group: The first group received twelve training sessions during 4 consecutive weeks, three times per week, 30 minutes per session including postural stability training with biodex balance system.
Category
Rehabilitation

2

Description
Dual task training group: The second group recieved twelve training sessions during 4 consecutive weeks, three times per week, 30 minutes per session including dual task training with biodex balance system and attention process training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razmejo-Moghadam Physiotherapy Clinic
Full name of responsible person
Dr. Asghar Akbari
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hoshang rafigdost
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
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, Zahedan University of Medical Sciences
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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
akbari_as@yahoo.com; a.akbari@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1322 8445
Email
akbari_as@yahoo.com; a.akbari@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
zahedan university of medical sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy,School of Rehabilitation Sciences,Razmjejo-Moghadam Laboratory,Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1322 8445
Email
akbari_as@yahoo.com; a.akbari@zaums.ac.ir
Web page address
www.zaums.ac.ir

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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