Objectives and design: Bracing along with exercising is the most effective protocol in patients with idiopathic scoliosis which have Cobb angles of 25 to 45 degrees. However, since the psychological aspects of scoliosis treatment may affect the quality of life, and the exact time for adjusting the pads of Milwaukee brace is unknown; therefore the aim of this study was evaluating the effect of exercising in a group with adjusting the brace in shorter intervals, in compared with routine protocol, in the treatment of idiopathic scoliosis. Setting and conduct: Thirty-four patients with idiopathic scoliosis which had Cobb angles of 50 to 15 degrees will be included in this study and will be divided into experimental and control groups. The patients of two groups will participate in an eleven-week treatment program, with different between the two groups. Quality of life scores of both groups will be evaluated before and after intervention using SRS-22 questionnaire, as well as scoliosis angles before and after the intervention according to the primary and secondary radio graphic X-rays. participants: patients referring to the rehabilitation center of red crescent society with the Late onset idiopathic scoliosis diagnosis. Intervention: Group exercising and brace adjustment at shorter intervals. Main outcome measures variables: Cobb angle, and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412094134N3
Registration date:2016-12-15, 1395/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-15, 1395/09/25
Registrant information
Name
Amir Ahmadi
Name of organization / entity
Rehabilitation collage of Iran university of medical science
Country
Iran (Islamic Republic of)
Phone
00982122227159 داخلي 353
Email address
amirahmadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group exercising and adjusting the brace at shorter intervals on Cobb angle and Quality of life of patients with Idiopathic scoliosis
Public title
Effect of group exercising and adjusting the brace at shorter intervals on Cobb angle and Quality of life of patients with Idiopathic scoliosis
Purpose
Treatment
Inclusion/Exclusion criteria
The main Inclusion criteria:Late-onset idiopathic scoliosis; Milwaukee brace prescription; Trunk muscle strength grade 3 or higher; and no history of surgery on the spine;
The main Exclusion criteria: no brace wearing for more than a week during the study; failure to follow the exercise program at home (i e. exercise less than 6 hours per week); absenteeism in the practice session (related to the experimental group); and the absenteeism in the 3 months references (the control group)
Age
From 8 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Rehabilitation college of Iran university of medical sciences
Befor intervention, three months after intervention
Method of measurement
Cobb method using Goniometer
2
Description
Quality of life
Timepoint
Befor intervention, three months after intervention
Method of measurement
SRS-22 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants in this group, will doing exercise in a group of at least 3 members, under the supervision of a therapist skilled in the correction movements. This group exercise will be continued for 11 weeks, 2 days per week and each session was 2 hours. The Milwaukee brace of each patients will be adjusted by an experienced Orthotist, after the sessions. In the days between sessions, patients will required to exercise at home, alone for two hours daily.
Category
Other
2
Description
Control group: The exercises will be given to the patients in brochure format and they will asked to do these exercises 2 hours daily, without supervision of the therapist and also their braces will be adjusted every 3 months according to the scoliosis research society (as it is the common method of conservative management of scoliosis).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation center of red crescent society of Iran
Full name of responsible person
Zahra Hedayati
Street address
Tehran, Vanak sq. , Yasemi st, Red Crescent Society of Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran university of medical sciences
Full name of responsible person
Dr. Ali Javad Mousavi
Street address
Hemat Highway, Iran University of Medical Sciences, Tehran
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Amir Ahmadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation faculty, Mdad karan st., Shah nazari AV, Mirdamad Blv., Madar Sq., Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
amirahmadi.pt@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Kamyab
Position
Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation faculty, Madad karan St., Shah Nazari Av., Madar Sq.,Mirdamad Blv., Tehran
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Fax
Email
mojtaba.kamyab@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Hedayati
Position
MSc Student
Other areas of specialty/work
Street address
School of Rehabilitation, Nezam st., Shahnazari st., Madar Sq., Mirdamad Blv., Tehran
City
Tehran
Postal code
1545913187
Phone
+98 21882012415
Fax
Email
zhr.hedayati@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)