The comparison of the effect of receiving feedback from healthy subjects and patients with Parkinsons disease while performing group balance task-oriented exercises on postural control in patient with Parkinsons disease
The aim of this study is to compare the effect of receiving feedback from healthy subjects and patients with Parkinson's disease in group balance exercises on balance of patient 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 feedback from healthy subjects and a group receiving feedback from patients with Parkinson's disease. The main inclusion criteria include having Parkinson's disease according to the neurologist diagnosis, having the disease's progression level of 1 to 3 as measured by Hoehn and Yahr Scale, an acceptable level of cognitive function, i.e. score of more than 21 on the Mini Mental Status Examination (MMSE). Subjects are excluded if they do not cooperate during the test and exercises and not return for testing after the intervention. Twenty-four sessions of group banace exercises are performed with receiving feedback from healthy subjects and patients with Parkinson's disease (8 weeks, 3 sessions per week, 60 minutes per session). Functional balance and postural control are evaluated with clinical and laboratory tests before and after receiving exercises in both group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092416830N5
Registration date:2015-11-24, 1394/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-24, 1394/09/03
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
Dr. Seyed Ali Javad Mousavi, Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of receiving feedback from healthy subjects and patients with Parkinsons disease while performing group balance task-oriented exercises on postural control in patient with Parkinsons disease
Public title
The comparison of the effect of receiving feedback from healthy subjects and patients with Parkinsons disease in group balance exercises on balance of patient with Parkinsons disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria for patients with Parkinson's disease: Having Parkinson's disease according to neurologist diagnosis; Having the disease's progression level of 1 to 3 as measured by Hoehn and Yahr Scale; Having an acceptable level of cognitive function, i.e. score of more than 21 on the Mini Mental Status Examination; Having the ability to walk independently and without assistive device at least 10 meters in length; Having at least a fifth grade education; Not having any other neurological diseases such as stroke according to the patient, or the patient's family or physician report; Not having any orthopedic problem 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; Not having pathologic dementia according to neurologist diagnosis; Not having Juvenile Parkinsonism. Inclusion Criteria for healthy subjects: No known pathological problems, according to the person and family report. Exclusion Criteria for patients with Parkinson's disease: 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. Exclusion Criteria for healthy subjects: Lack of cooperation during the test or exercises.
Age
From 40 years old to 70 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.IUMS.rec.1394.26527
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
Berg Balance Scale, Functional Reach test, Timed Up and Go,6 Miniutes Walking test
Intervention groups
1
Description
Group receiving group banace exercises with feedback from healthy subjects: Twenty- four sessions of group banace exercises with receiving feedback from healthy subjects (8 weeks, 3 sessions per week, 60 minutes per session)
Category
Rehabilitation
2
Description
Group receiving group banace exercises with feedback from patients with Parkinson's disease: Twenty-four sessions of group banace exercise with receiving feedback from patients with Parkinson's disease (8 weeks, 3 sessions per week, 60 minutes per session)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational therapy clinic, Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Street address
Occupational Therapy Department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences,Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr. Seyed Ali Javad Mousavi, Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Street address
Occupational Therapy Department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences,Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Seyed Ali Javad Mousavi, Vice Chancellor for research of 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
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Master of Science
Other areas of specialty/work
Street address
Occupational Therapy Department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences,Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
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
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Master of Sciense
Other areas of specialty/work
Street address
Occupational Therapy Department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences,Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
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
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Master of science
Other areas of specialty/work
Street address
Occupational Therapy Department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences,Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
gh_taghizade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)