Protocol summary

Summary
(1) Objectives: The purpose of this study is to evaluate the effect of the x box-kinect game in hyperkyphosis women on posture and respiratory parameter improvement. (2) Design: Design of this study is randomized single blind clinical trial. (3) Setting and conduct: Participants are collected among students and medical personnel of Shiraz University of Medical Science. The evaluation of the participants will conduct by another examiner who is unclear from the categorization of the study groups and type of treatment. 32 individuals will be assigned by block randomization either to control or intervention groups and are not aware that they will belong to each groups. (4) Participants including major eligibility criteria: Inclusion criteria are women aged between 18 to 35 years old; with hyperkyphosis disorder or at least one of their respiratory parameters are less than normal average. Participant with muscle-skeletal or respiratory disorders or are treated by other ways will be excluded from this study. (5) Intervention: Both groups will receive stretching and strengthening exercises during 4 weeks (12 session and 3 days per week), while the intervention group will receive fitness and dance exercises of the x box kinect game as well. (6) main outcome measures (variables): Kyphosis angle via flexible ruler and respiratory parameters via spirometer will be measured for each individual in the beginning and end of 12th session.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201704112391N37
Registration date: 2017-07-10, 1396/04/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-10, 1396/04/19
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sience
Expected recruitment start date
2017-07-09, 1396/04/18
Expected recruitment end date
2017-08-09, 1396/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the x box Kinect game on posture and respiratory parameters in hyperkyphosis female students and staff in Shiraz University of Medical Science
Public title
The effects of the x box Kinect game on posture and respiratory parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 18 to 35 years old; having hyperkyphosis; at least one of their respiratory parameters of this study will be less than normal average. Exclusion criteria: Neuron, muscle-skeletal and rheumatology disorders; vertebra fractures; scoliosis or spinal disorder; subjects treated with brace, drugs, exercise therapy or other treatment in the last 6 months; pregnancy; asthma and other respiratory disease; balance disorder; using corticosteroids during more than 2 months; contraindication for spirometery test(such as: hypertension above 180 mmhg, history of heart attack or unstable angina, recent eye and ear surgery, abdominal aortic aneurism); subjects who cannot learn to exercise.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The participants of this study will be assigned by block randomization either to control or intervention groups and they will receive one of the treatment options. They will be assessed and treated by two physical therapist. One of them who is blind to allocated treatment groups will assess the individuals and the other one will treat the individuals in both groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of research in Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand Blvd.
City
Shiraz
Postal code
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
ir.sums.rec.1395.153

Health conditions studied

1

Description of health condition studied
Subjects with hyperkyphosis
ICD-10 code
M40.0,M40.
ICD-10 code description
Postural kyphosis,Other secondary kyphosis,Other and unspecified kyphosis,

Primary outcomes

1

Description
Kyphosis angle
Timepoint
Befor intervention,Immediately after intervention set
Method of measurement
In terms of degree via flexible ruler

2

Description
Respiratory parameters(FVC, FEV1, FEV1/FVC )
Timepoint
Befor intervention,immediately after intervention set
Method of measurement
Using spirometer in terms of liter and percentage

Secondary outcomes

1

Description
Age
Timepoint
Before treatment and immediately after intervention set
Method of measurement
By questioning individuals and on the basis of years

2

Description
Height
Timepoint
Before treatment and immediately after intervention set
Method of measurement
By use of mesure tape( cm)

3

Description
Weight
Timepoint
Before treatment and immediately after intervention set
Method of measurement
By use of scale( kg)

Intervention groups

1

Description
In intervention group, individuals playing x box kinect(fitness game and dancing) in addition to regular training of control group,in 3 days of a week for 4 weeks
Category
Other

2

Description
In control group, participants perform stretching and strengthening exercises for 4 weeks and 3 days per week.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Clinic of Shiraz University of Medical Science
Full name of responsible person
Sahba Taslimipour
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Central building of Shiraz University of Medical Science, Zand Blvd
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 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
School of Rehabilitation Sciences
Full name of responsible person
Sahba Taslimipour
Position
Student in master of science
Other areas of specialty/work
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Postal code
33669-71947
Phone
+98 7107136265108
Fax
Email
sahba_taslimipour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation
Full name of responsible person
Zahra Rojhani Shirazi
Position
Ph.D of physical therapy
Other areas of specialty/work
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation
Full name of responsible person
Zahra Rojhani Shirazi
Position
Associate professor/Ph.D
Other areas of specialty/work
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Postal code
Phone
+36 271552
Fax
Email
rojhaniz@yahoo.com
Web page address

Sharing plan

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