Protocol summary

Summary
Objectives:Evaluation of trans cranial direct current stimulation effect on balance,sleep quality,life quality and fatigue in Parkinson disease patients.Design:Patients with Parkinson disease after randomized selection based on study inclusion criteria by Physical Medicine and Rehabilitation specialist divides to tow groups, anodal trans cranial direct current stimulation plus occupational therapy and sham anodal trans cranial direct current plus occupational therapy.Setting and conduc and intervention: Questionnaires is filled and then 8 sessions anodal trans cranial direct current plus occupational therapy is performed. Just after that and 3 months later questionnaires will be refilled and effects of this method on patient's balance, sleep quality, life quality and fatigue will be evaluated.main outcome measures: balance,sleep quality,life quality and fatigue

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070123012N1
Registration date: 2015-08-24, 1394/06/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-24, 1394/06/02
Registrant information
Name
Maryam Rafiei
Name of organization / entity
Iran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
maryam.rafiei.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of trans cranial direct current stimulation effect on balance, sleep quality, life quality and fatigue in Parkinson disease patients.
Public title
Evaluation of rehabilitation effect on balance, sleep quality, life quality and fatigue in Parkinson disease patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All of the patients should be in stage 2 or 3 of Parkinson disease based on Hoehn and Yahr criteria and also should: be under stable pharmacological treatment regime at least 30 days before entrance in study; be in stable clinical condition to complete the study; have appropriate primary response to Levo-DOPA or it's agonist; not have Parkinson related dementia; not have abnormal MRI; not have drug related parkinsonism. Exclusion criteria: patient unwillingness to complete the study; patient inability to complete the study because of any reason at any time during the study.
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)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization with usage of enclosed envelopes

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway, Tehran
City
Tehran
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
93/d/105/3485

Health conditions studied

1

Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson disease, Incl: Hemiparkinsonism, Paralysis agitans Parkinsonism or Parkinson disease: NOS, idiopathic, primary

Primary outcomes

1

Description
Balance
Timepoint
Before, just after 8 sessions of trans cranial direct current stimulation plus occupational therapy and 3 months later.
Method of measurement
Berge-Balance questionnare

2

Description
Sleep quality
Timepoint
Before, just after 8 sessions of trans cranial direct current stimulation plus occupational therapy and 3 months later
Method of measurement
Epworth questionnaire

3

Description
Life quality
Timepoint
Before, just after 8 sessions of trans cranial direct current stimulation plus occupational therapy and 3 months later
Method of measurement
EQ-D5 questionnaire

4

Description
Tiredness
Timepoint
Before, just after 8 sessions of trans cranial direct current stimulation plus occupational therapy and 3 months later
Method of measurement
Fatigue severity scale questionnaire

Secondary outcomes

1

Description
Side effects
Timepoint
During and just after each session of trans cranial direct current stimulation performance
Method of measurement
Asking from a patient

Intervention groups

1

Description
8 sessions of trans cranial direct current stimulation with 2 Millie Ampere current during 20 minutes and then occupational therapy will be performed.
Category
Rehabilitation

2

Description
8 sessions of sham trans cranial direct current stimulation and then occupational therapy will be performed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Dr Maryam Rafiei
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Iran University of Medical Sciences
Full name of responsible person
Dr. Bijan Forogh
Street address
Physical Medicine and Rehabilitation department, Firoozgar hospital, 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
Vice chancellor for research,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
Firoozgar hospital
Full name of responsible person
Dr. Maryam Rafiei
Position
Resident
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation, Firoozgar hospital, Valiasr squere, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
sunmarymoon@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Dr. Bijan Forogh
Position
Physical Medicine and Rehabilitation specialist
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation, Firoozgar hospital, Valiasr squere, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
bijan.fr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Dr. Maryam Rafiei
Position
resident
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8214 1229
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...