The effect of cognitive and motor dual task training on improvement of balance, some kinematic parameters of gait cycle and fear of falling in people with idiopathic Parkinson’s disease
The effect of cognitive and motor dual task training on improvement of balance, some kinematic parameters of gait cycle and fear of falling in people with idiopathic Parkinson’s disease
Design
Clinical trial with two intervention groups and one control group, no blinded, no randomized
Settings and conduct
This is a quasi-experimental study. Subjects will be assessed before training, after ten weeks training, and one month after the last session of training in Poursina Hospital in Rasht.
Participants/Inclusion and exclusion criteria
Inclusion criteria: To have II-III score in Hoehn- Yahr scale; to be able to walk independently to 100 meters; to be able to do simple orders
Exclusion criteria: Subjects with cardiovascular and pulmonary disorders; subjects with significant cognitive disorders
Intervention groups
Intervention groups: Cognitive dual task training; motor dual task training Control group: exercise group without dual task training
Main outcome variables
balance; some kinematic parameters of gait cycle; fear of falling; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180106038239N1
Registration date:2018-03-03, 1396/12/12
Registration timing:registered_while_recruiting
Last update:2018-03-03, 1396/12/12
Update count:0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Tahereh Pourkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4222 3783
Email address
zpourkhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive and motor dual task training on improvement of balance, some kinematic parameters of gait cycle and fear of falling in people with idiopathic Parkinson’s disease
Public title
The effect of exercise in people with idiopathic Parkinson’s disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
PD patients diagnosed with Hoehn and Yahr score of 2 or 3
Prescribed one or more anti-parkinsonism medications by a consultant neurologist or consultant physician with specialist knowledge of neurological disorders
Stable medication use; that is, not altered within the previous month and not expected to change during next 3 months
Willing to be assigned to any of the three interventions
Able to walk 100 m independently with or without gait aids;
Able to do simple orders and getting a score more than 24 on the Mini-Mental Status Examination (MMSE)
Age between 50-75
Getting a score less than 14 in Beck Depression Inventory
Exclusion criteria:
Any clinical condition that make it impossible to use physical effort
Patients with cardiovascular and pulmonary diseases
Significant physical limitations
Sensory system pathology affecting walking (e.g. blindness, deafness).
To have a surgery for PD such as deep brain stimulation
Suspected Parkinsonism due to causes other than idiopathic PD.
Current participation in any other behavioral or exercise programs.
Participation of a structured exercise program in the preceding 2 months.
Unavailability during the period of the study.
Patients with dementia or significant cognitive impairment
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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
Syadati street, Namjou Avenue
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.GUMS.REC.1396.381
Health conditions studied
1
Description of health condition studied
Parkinson's Disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
The ability of body for keeping the equilibrium.
Timepoint
Before training, after ten weeks of training, after one month of the last session of training
Method of measurement
Up and go test
2
Description
kinematic parameters of gait cycle
Timepoint
Before training, after ten weeks of training, after one month of the last session of training
Method of measurement
by motion analyzer system
3
Description
fear of falling
Timepoint
Before training, after ten weeks of training, after one month of the last session of training
Method of measurement
Falls Efficacy Scale-International
4
Description
quality of life
Timepoint
Before training, after ten weeks of training, after one month of the last session of training
Method of measurement
quality of life assessment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: cognitive dual task training: In addition to exercise protocol during 10 weeks, three times a week and 45 minutes per session, subjects will do a cognitive task like reverse counting by three, to answer to the examiner's cognitive questions, to learn a list of words and repeat them after sets of exercises, simultaneously.
Category
Rehabilitation
2
Description
The second intervention group: motor dual task training: In addition to exercise protocol during 10 weeks, three times a week and 45 minutes per session, subjects will do a motor task like carrying a dish with a water glass on it, buttoning up the blouse or shirt, to take objects like wallet or cell phone from the pocket
Category
Rehabilitation
3
Description
Control group: to do exercise protocol during 10 weeks, three times a week and 45 minutes per session
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Poursina Hospital
Full name of responsible person
Dr Seyed Mehdi Zyabari
Street address
Parastar
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Fax
+98 13 3333 9842
Email
poursina_pr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Syadati Ave. Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4415735551
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
nemati@gums.ac.ir
Web page address
http://www.gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh Pourkhani
Position
Physical Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Khalije Fars Avenue
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13336904858
Email
zpourkhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh Pourkhani
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 44, 3rd Nima Street
City
Lahidjan
Province
Guilan
Postal code
4415735551
Phone
+98 13 4222 3783
Fax
Email
zpourkhani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh Pourkhani
Position
Ph D Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 44, 3rd Nima Street
City
Lahidjan
Province
Guilan
Postal code
4415735551
Phone
+98 13 4222 3783
Email
zpourkhani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available