Thirty patients with idiopathic Parkinson's disease, who have balance disorder, using simple sampling are selected by neurologist and referred to physical medicine and rehabilitation research center of Imam Reza hospital for physical therapy and balance training programs during a five- month period. Demographic characteristics, speed of walking and balance status for suitable patients with inclusion criteria are evaluated and recorded. Balance status using Berg Balance Scale questionnaire as well as biodex balance training instrument which assesses "fall risk" and "postural instability" indexes, will be measured. All of findings will be recorded in a check list of research. Patients are undergoing 12 sessions (4 weeks, three sessions /every week) and each session 10-20 minutes, of physical therapy and balance strengthening exercises which is static training. Obtained Changes in baseline parameters of balance indexes and questionnaire score before and after interventions will be compared and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212163217N6
Registration date:2013-01-01, 1391/10/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-01, 1391/10/12
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2012-12-22, 1391/10/02
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of balance training using balance simulator instrument on postural stability in the patients with idiopathic parkinsone disease
Public title
balance training on idiopathic parkinson disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1-diagnosis of parkinsone disease by neurologist, 2-stages of 1-3 of disease,3-ability to walking at least 150 steps without assistive devices, 4-on medical treatment for 2 weeks before study,5-good endurance for standing without help at least 30 minutes.
Exclusion criteria:1-mini mental status exam less than 24,2-changes in medication dosage during the study,3-uncontrolable orthostatic hypothension,4-symptomatic coronary artery disease, 5-lower limb fractures during the past 6 months,6-vestibular diseases, 7-severe depression,8-visual acuity less than 20/40,9-any medical problem which can affect security of prescribed protocol,10-severe musculuskeletal disorders which causes limitation of performance in planned balance training.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Chancellor for research, Tabriz University of Medical Sciences
Street address
Chancellor for research, 3rd floor, Central building number 2, Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz
City
tabriz
Postal code
51656
Approval date
2012-12-22, 1391/10/02
Ethics committee reference number
8835/4/5
Health conditions studied
1
Description of health condition studied
Idiopathic parkinsonism
ICD-10 code
G20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Time up & go (TUG)
Timepoint
before & after intervention
Method of measurement
using chronometer, six meter distance is measured by seconds.
2
Description
Berg Balance Scale(BBS)
Timepoint
before & after intervention
Method of measurement
using subjective and objective exam and filling out of BBS questionnaire
3
Description
Fall risk
Timepoint
before & after intervention
Method of measurement
using Biodex balance training is measured and because it is a relative value,it has not special unit.
4
Description
Postural Stability
Timepoint
before & after intervention
Method of measurement
using Biodex balance training is measured and because it is a relative value,it has not special unit.
Secondary outcomes
1
Description
effect of age and sex on outcome meaurment
Timepoint
before and after intervention
Method of measurement
correlation between factors of age and sex with improvement
2
Description
number of falls
Timepoint
before and after intervention
Method of measurement
subjective with inquiring from patient
Intervention groups
1
Description
12 sessions of physical therapy and balance training are performed in physical medicine and rehabiliation department for parkisons patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Nasim Borhani
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical medicine and rehabilitation researches center
Full name of responsible person
Mr. Nami
Street address
Emam Reza hospital - Department of Physical medicine and rehabilitation researches center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical medicine and rehabilitation researches center
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
Tabriz University of Medical Science
Full name of responsible person
Nasim Borhani
Position
Medicine Student
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward , Imam Reza Hospital ,Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
dr.nasim66@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical Medicine and Rehabilitation Research Center,Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamian
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave