Investigate the effect of exercise therapy on knee proprioception in girls with benign hypermobility syndrome
Design
The sample size was 12 subjects in each group (control and intervention group) and a total of 24 people. The subjects were randomly divided into two groups by block method. The experimental group received exercise for 4 weeks, but the control group did not receive any exercise.
Settings and conduct
This study was conducted in Rehabilitation school of Shiraz University of Medical Sciences and in this regard, two groups(experimental and control groups) were included . In both groups, knee pain, proprioception and quality of life were measured using the VAS, goniometer and SF-36 questionnaire were measured initially and after four weeks of intervention respectively. This study was assessor blinded in a way that the evaluator did not know the nature of the subjects in each group.
Participants/Inclusion and exclusion criteria
Girls with knee pain and benign hypermobility aged 18 to 30 years were included. In the case of people with neurological diseases, other musculoskeletal problems, rheumatoid diseases, osteoarthritis, history of trauma to knee and athlete, were excluded.
Intervention groups
Control and experimental group were considered; The experimental group received exercise for 4 weeks, but the control group did not receive any exercise.
Main outcome variables
Balance; Proprioception
General information
Reason for update
Acronym
BHS
IRCT registration information
IRCT registration number:IRCT20170619034634N2
Registration date:2018-10-28, 1397/08/06
Registration timing:retrospective
Last update:2018-10-28, 1397/08/06
Update count:0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
mahnaz daman
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 5108
Email address
daman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
shiraz university of medical sciences- rehabilitation school
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
2015-07-23, 1394/05/01
Actual recruitment end date
2015-08-23, 1394/06/01
Trial completion date
empty
Scientific title
Investigate the effect of exercise therapy on knee proprioception in girls with benign hypermobility syndrome aged 18-30 years old
Public title
Effect of exercise on knee proprioception in girls with benign hypermobility syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having benign hypermobility syndrome
Pain in knee
Female
Age range between 18-30 years old
Exclusion criteria:
Neurological disorders
Musculoskeletal disorders
Rheumatoid diseases and joint inflammatory diseases
Osteoarthritis
ligaments injury
Severe trauma to knee joint
Athlete
joint replacement in lower limb
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: limited randomization, block
Random unit: Individual
Considering the presence of two treatment groups in this study (experimental group A, control group B), the size of the blocks was 4. According to the number of samples (24 persons), 6 blocks were determined.
1-AABB
2-ABAB
3-BABA
4-BBAA
5-ABBA
6-BAAB
Table of random numbers were used to randomize the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were unaware of which group (control or experiment) were placed
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Central department of Shiraz University of Medical Sciences, Shiraz
City
Shiraz
Province
Fars
Postal code
14336-71348
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
IR.SUMS.REC.1393.7098
Health conditions studied
1
Description of health condition studied
Benign hypermobility syndrome
ICD-10 code
M35.7
ICD-10 code description
Hypermobility syndrome
Primary outcomes
1
Description
knee proprioception
Timepoint
before and after intervention
Method of measurement
goniameter
Secondary outcomes
1
Description
Pain and quality of life
Timepoint
Before and after intervention
Method of measurement
VAS and SF-36 questionniare
Intervention groups
1
Description
"Intervention group:" 10 session exercise therapy such as balance and proprioception exercises were performed for participants in intervention group.
Category
Other
2
Description
"Control group:" ِDid not receive any treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation school of Shiraz university of medical sciences
Full name of responsible person
Taghizade Shohreh
Street address
Abivardi 1 street, Chamran Blvd, Rehabilitation school of Shiraz University of Medical Siences
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3626 5108
Email
Taghizadeh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research Shiraz University of Medical Sciences
Full name of responsible person
Hashemi Seyed basir
Street address
Zand street, Shiraz University of Medical Siences
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3235 7282
Email
Hashemib@sums.ac.ir
Grant name
Thesis
Grant code / Reference number
92-01-06-7098
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Taghizade Shohreh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abivardi 1 street, Chamran Blvd, Rehabilitation school of Shiraz University of Medical Siences
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71936265108
Fax
Email
Taghizsh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Taghizadeh Shohreh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abivardi 1 street, Chamran Blvd, Rehabilitation school of Shiraz University of Medical Siences
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3626 5108
Fax
Email
Taghizsh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz daman
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Abivardi 1 street, Chamran Blvd, Rehabilitation school of Shiraz University of Medical Siences
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+7 136265108
Fax
Email
Daman@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The participants' informed consent form, balance data, proprioception and pain and quality of life are available.
When the data will become available and for how long
The relevant data are available after publication of the study.
To whom data/document is available
All reserchers can use data of this research
Under which criteria data/document could be used
Applicants are also allowed to do other analyzes and study development.
From where data/document is obtainable
The request will be sent to the authors of the email that are listed in the order of priority:
Taghizadeh@sums.ac.ir
Hemmatiladan@gmail.com
Mahnaz_daman@yahoo.com
What processes are involved for a request to access data/document