The aim of this study is to investigate the effect of sensory reweighting as a method of balance exercises on postural control in Patients with Parkinson's disease. In this clinical trial study, 40 patients with idiopathic Parkinson's disease are randomly assigned to two groups: a group receiving sensory reweighting as a method of balance exercises and control group. The main inclusion criteria include having Parkinson's disease according to neurologist diagnosis, the disease progression level of 1 to 3 according to Hoehn and Yahr Scale, the ability to perform the most difficult condition of laboratory test (quiet standing for 180 seconds while vibration is applied on the Achilles tendons of both sides and attention to visual stimulus) and an acceptable level of cognitive function, i.e. score of more than 21 on the Mini Mental Status Examination (MMSE). In case of no cooperation during the test and exercises and not returing for testing after the interventions, subjects are excluded. Intervention group receives 12 sessions of sensory reweighting as a method of balance exercises (3 sessions per week, 45-60 minutes per session). Control group does not receive these exercises. Functional balance and postural control are evaluated with clinical and laboratory tests before and after receiving exercises in intervention group and before and after 4 weeks in control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040616830N4
Registration date:2015-05-16, 1394/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Ghorban Taghizadeh
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
taghizadeh.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Sensory Reweighting as a Method of Balance Exercises on Postural Control in Patients with Parkinson's Disease
Public title
The effect of balance exercises on balance of patients with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Having Parkinson's disease according to neurologist diagnosis; Having the disease progression level of 1 to 3 according to Hoehn and Yahr Scale; Having an acceptable level of cognitive function, i.e. score of more than 21 on the Mini Mental Status Examination (MMSE); Having the ability to walk independently and without assistive device at least 10 meters in length; Having at least a fifth grade education; Having the ability to perform the most difficult condition of laboratory test (quiet standing for 180 seconds while vibration is applied on the Achilles tendons of both sides and attention to visual stimulus); Having no other neurological diseases such as stroke according to the patient, or the patient's family or physician report; Not having any orthopedic problem (such as low back pain, arthritis, Hallux valgus, flat foot) according to the patient, or the patient's family or physician report; Not having diabetes or addiction according to the patient, or the patient's family or physician report; No history of falling during the past month according to the patient, or the patient's family report.
Exclusion Criteria: Lack of patient cooperation during the test or exercises; Not return for doing tests after the intervention; Entering to the nonpharmacologic on-off phase of the disease during the study according to neurologist diagnosis; Change in the pharmacologic regimen of the patient during the study.
Age
From 55 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Iran University of Medical Sciences
Street address
Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2014-09-20, 1393/06/29
Ethics committee reference number
93-02-125-24715-104438
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Extrapyramidal and movement disorders
Primary outcomes
1
Description
Postural control
Timepoint
before and after intervention
Method of measurement
forceplate
Secondary outcomes
1
Description
Functional balance and mobility
Timepoint
before and after intervention
Method of measurement
Fuctional reach test, Berg Balance Scale, Time Up&Go test
Intervention groups
1
Description
Intervention group: receives 12 sessions of sensory reweighting as a method of balance exercises (3 sessions per week, 45-60 minutes per session). Exercises include proprioceptive, visual, vestibular, combination of proprioceptive and vestibular, combination of visual and vestibular, combination of proprioceptive and visual stimulations.
Category
Rehabilitation
2
Description
Control group: does not receive these exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational therapy clinic, School of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences, Dr. Seyed Ali Javad Moosavi
Full name of responsible person
Dr Mossavi
Street address
Iran University of Medical Sciences
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 of Iran University of Medical Sciences, Dr. Seyed Ali Javad Moosavi
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
Ghorban Taghizadeh
Position
Master of Sciense
Other areas of specialty/work
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
gh_taghizade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Master of Sciense
Other areas of specialty/work
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
gh_taghizade@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Master of Sciense
Other areas of specialty/work
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)