Comparison of the effect of Pilates exercises and unstable support surface balance exercises on parameters of gait cycle and falling risk in patients with Parkinson’s disease
The aim of this control trial is to compare the effect of Pilates exercises and unstable support surface balance exercises on parameters of gait cycle and falling risk in patients with Parkinson’s disease. The research statistical population includes all patients with PD who referred to neurologists in 2016 in Guilan Province. From among the desired people, 48 patients with IPD select through available targeted non-random method and they randomly and consecutively divide into two experimental groups and one control group. Also participants and assessors will be blinded. The research entry criteria include having IPD at moderate levels (levels II and III) and age over 50 years old and exit criteria include pain, any disorder influencing the security of practice program and unwillingness to be present at the research process. Pilates and balance exercise program will be done three 1-hour sessions per week for 8 weeks for experimental group, while control group will start walking in the duration similar to experimental groups. Before and after 8 weeks, parameters of gait cycle and falling risk indicators will be evaluated in three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071228885N1
Registration date:2016-08-04, 1395/05/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Shaghayegh Sayyar
Name of organization / entity
Guilan University
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 7049
Email address
shaghayegh@msc.guilan.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Guilan
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Pilates exercises and unstable support surface balance exercises on parameters of gait cycle and falling risk in patients with Parkinson’s disease
Public title
the effect of exercises on motor symptoms of Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having IPD at moderate levels (levels II and III); age over 50 years old; passage of at least 3 years after the disease diagnosis; lack of other neurological diseases or any acute and chronic physical or mental disorder; lack of cognitive disorders with the approval of a specialist physician; the ability to stand and walk independently; not using assistive devices for keeping balance and walking; the history of balancing and walking disorders due to PD; non-participation in sports activities and or physiotherapy treatments influencing the research process; the ability to participate in practice sessions regularly. Exclusion criteria: pain; limbs’ deformation and any disorder influencing the security of practice program; unwillingness to be present at the research process.
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Guilan University of Medical Sciences
Street address
Office center of Guilan University of Medical Sciences, Parastar St., Rasht, IRAN
City
Rasht
Postal code
4193893345
Approval date
2016-02-02, 1394/11/13
Ethics committee reference number
IR.GUMS.REC.1394.460
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Paremeters of gait cycle
Timepoint
before and after intervention
Method of measurement
two-dimensional motion analysis
Secondary outcomes
1
Description
Functional balance
Timepoint
before and after intervention
Method of measurement
Fullerton Balance Scale
2
Description
Falling risk
Timepoint
before and after intervention
Method of measurement
Timed Up and Go test, self report
Intervention groups
1
Description
Pilates exercises (Experimental group)
Category
Rehabilitation
2
Description
unstable support surface balance exercises (experimental group)
Category
Rehabilitation
3
Description
Walking (control group)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Medical & Educational Center
Full name of responsible person
Dr. Babak Bakhshayesh
Street address
Office center of Guilan University of Medical Sciences, Parastar St., Rasht, IRAN
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Physical Education and Sport Science, University of Guilan
Full name of responsible person
Dr. Mehrali Hematinezhad
Street address
Khalij Fars highway (5th kilo meter of Ghazvin road), Rasht, Iran
City
Rasht
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, Faculty of Physical Education and Sport Science, University of Guilan
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
Faculty of Physical Education and Sport Science, University of Guilan
Full name of responsible person
Dr. Mehrali Hematinezhad
Position
Professor/ Vice chancellor for research, Faculty of Physical Education and Sport Science, University
Other areas of specialty/work
Street address
Khalij Fars highway (5th kilo meter of Ghazvin road), Rasht, Iran
City
Rasht
Postal code
4199843653
Phone
+98 13 3369 0685
Fax
+98 13 3369 0675
Email
ma_hemati@yahoo.com
Web page address
http://guilan.ac.ir/fe
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University
Full name of responsible person
Shaghayegh Sayyar
Position
MSc/ Student
Other areas of specialty/work
Street address
Khalij Fars highway (5th kilo meter of Ghazvin road), Rasht, Iran
City
Rasht
Postal code
4199843653
Phone
+98 11333690685
Fax
+98 13 3369 0675
Email
Shaghayegh.sayyar@yahoo.com
Web page address
http://guilan.ac.ir/fe
Person responsible for updating data
Contact
Name of organization / entity
Guilan University
Full name of responsible person
Shaghayegh Sayyar
Position
MSc/ Student
Other areas of specialty/work
Street address
Khalij Fars highway (5th kilo meter of Ghazvin road), Rasht, Iran
City
Rasht
Postal code
4199843653
Phone
+98 13 3369 0685
Fax
+98 13 3369 0675
Email
shaghayegh.sayyar@yahoo.com
Web page address
http://guilan.ac.ir/fe
Sharing plan
Deidentified Individual Participant Data Set (IPD)