Trial no.:	PACTR201610001688252	Date of Registration:	20/06/2016
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

IMMEDIATE AND LATE EFFECT OF CRYOTHERAPY ON BALANCE IN HEALTHY SUBJECTS

Official scientific title

IMMEDIATE AND LATE EFFECT OF CRYOTHERAPY ON BALANCE IN HEALTHY SUBJECTS

Brief summary describing the background and objectives of the trial

Cryotherapy is commonly used in treatment acute and chronic injury. The aims of cryotherapy interventions include reduce pain, control inflammation, reduce edema and prevent secondary injury. Due to the mounting evidence that cryotherapy has deleterious immediate effects on functional activities, a further understanding of possible impairments related to this commonly used treatment is warranted. Prior authors have reported decreased static standing balance following the effect of cryotherapy. However measures of dynamic standing balance may better represent the demands of lower extremity during functional tasks. Only one study measures the dynamic balance with many limitations finding from this study might fill the gab in research about the effect of cryotherapy on dynamic balance. In addition the current study will be clarify the difference between the immediate and late effect changes in dynamic balance after ice application and test the difference in the balance between both sexes after ice application which was missing in all previous studies. Finding from this study might assist clinicians in decision making regarding the use of cryotherapy within a treatment session or when considering return to play after an athletic injury.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

dynamic balance

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

01/12/2015

Actual trial start date

01/12/2015

Anticipated date of last follow up

06/06/2016

Actual Last follow-up date

Anticipated target sample size (number of participants)

30

Actual target sample size (number of participants)

30

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study	Randomised	stratified allocation	Numbered containers	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	cold gel pack	once	15 minutes	cold gel pack will wrapped with a towel and supported with elastic strap around the ankel joint of domain lower extremity	30	Active-Treatment of Control Group
Control Group	Room temperature	Once	15 minutes	Put the ankel jont at room temperature	30	Placebo

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
The patient age will range from 18 to 40 years. Subjects free from musculoskeletal diseases and neurological diseases affecting the lower limb. Each subjects will receive a detailed explanation of the study and a form of consent will assign prior to participation.	Subjects with musculoskeletal disorders in lower limb. Subjects who had infected skin diseases and loss of sensations. Metabolic or vascular disease with neurological component such as diabetes. Previous ankle operation. Recent injury of ankle joint.		18 Year(s)	40 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

15/10/2015

Faculty of physical therapy ,cairo university

Ethics Committee Address
Street address	City	Postal code	Country
7 ahmed el zayat street.Dokky	Giza	12613	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	dynamic standing balance with open and close eye	Immediate after ice application . 30 minutes later. 60 minutes later.
Secondary Outcome	Static standing balance with open and close eye	Immediately after ice application. 30 minutes later. 60 minutes later.

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Modern University	el mokattam	Cairo	11571	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
modern universty	el mokattam	cairo	11571	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Cairo university	Giza	Giza	12613	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
cairo university	Giza	Giza	12613	Egypt
modern university	el motattam	cairo	11571	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Yomna Farag	dr_mone19@hotmail.com	01115162092	maadi
City	Postal code	Country	Position/Affiliation
cairo	11728	Egypt	assisstant lecturer
Role	Name	Email	Phone	Street address
Public Enquiries	Yomna Farag	dr_mone19@hotmail.com	01115162092	maadi
City	Postal code	Country	Position/Affiliation
cairo	11728	Egypt	assisstant lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	Yomna Farag	dr_mone19@hotmail.com	01115162092	maadi
City	Postal code	Country	Position/Affiliation
cairo	11728	Egypt	assisstant lecturer

REPORTING
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URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date

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Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry