Protocol summary

Summary
The statistical population of this research includes all companions of patients referred to physiotherapy clinics in Isfahan in 1395. By using the available sampling, among the volunteers in the study, individuals aged between eighteen and thirty will be selected according to the criteria for entering and leaving the research as participants, and after completing the consent form, they will be included in the study. Inclusion criteria include ages 18 to 30 years; BMI between 18 and 25; exclusion criteria including any pathological symptoms, fracture history, surgery, or joint diseases in the lower extremities; history of ankle ligament damage; history of sensory and motor disorder; Cold allergy including Raynaud's disease; professional athlete; visual impairment; any skin lesions; vascular problems; pathological problems of the spine; foot problems; central nervous system problems affecting balance. The exam will be conducted in a session. At the beginning of the session, after recording general information including height and weight, the length of the lower limb is measured from the anterior superior iliac spine to the ankle in the supine position. The training and exercises required for performing equilibrium tests will be provided. The modified equilibrium test of the star in three directions is then used to evaluate dynamic equilibrium and a standing on one leg with closed eyes to assess the static equilibrium on the dominant foot, and the score will be recorded for each person. The static and dynamic equilibrium test will be arranged randomly and by throwing coins. After equilibrium evaluation, randomly, for a group of participants, twenty minutes of ice bag will be used on the dominant ankle and for the other group the cold spray will be used for five seconds with a distance of 30 cm and an angle of 30 degrees from the dominant ankle surface. Immediately after applying the cold, star's equilibrium test and a stand on one leg with closed eyes test on the dominant leg will be done and the scores will be recorded. The Star test and the stand on one leg with closed eyes test will be repeated for 30 minutes and one hour after cold application in both methods and the results will be recorded. In this study, blindness was not made.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102930544N1
Registration date: 2017-08-04, 1396/05/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-04, 1396/05/13
Registrant information
Name
Shabnam Talebi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 1350
Email address
talebishabnam62@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the immediate and late effects of local ankle cooling by cold spray and ice pack on balance in healthy subjects
Public title
Comparing the immediate and late effects of local ankle cooling by cold spray and ice pack on balance in healthy subjects
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria : age:18-30 BMI: 18-25 Exclusion criteria:pathological symptoms, fracture history, surgery, or joint diseases in the lower extremities; Ankle ligaments injury; Sensory and motor disorders; Cold sensitivity and rynode disease; Profasional athletes; Cutaneous injury or disease; Vascular problem; Spinal clumn pathologic problem; Foot problem; Balance disorder
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib St , Isfahan
City
Isfahan
Postal code
Approval date
2016-10-06, 1395/07/15
Ethics committee reference number
1395.7.395527

Health conditions studied

1

Description of health condition studied
Balance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Static balance
Timepoint
Immediately after intervention, thirty minutes and one hour after intervention
Method of measurement
Stand on one leg with closed eyes

2

Description
Dynamic balance
Timepoint
Immediately after intervention, thirty minutes and one hour after intervention
Method of measurement
Y test

Secondary outcomes

1

Description
The skin temperature
Timepoint
immediately, thirty minutes and one hour after intervention
Method of measurement
Skin Thermometer

Intervention groups

1

Description
Group one Apply 20 minutes of ice bag on ankle
Category
Other

2

Description
Group two Apply cold spray for 5 seconds on ankle
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taskin Physiotherapy Center
Full name of responsible person
Shabnam Talebi
Street address
Bahonar St., Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezarjarib St., Isfahan
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mojtaba Heshmati poor
Position
Faculty member
Other areas of specialty/work
Street address
Hezarjarib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2084
Fax
Email
heshmatipour @ rehab.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mojtaba Heshmati poor
Position
Masters
Other areas of specialty/work
Street address
Hezarjarib St ,Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2084
Fax
Email
Heshmatipour @ rehab.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shabnam Talebi
Position
Masters student
Other areas of specialty/work
Street address
Sheikh Sadoogh shomali St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3662 1350
Fax
Email
Talebishabnam62@Gmail.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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