The effect of action observation training on kinetic and kinematic parameters of gait and quantitative electroencephalography (qEEG) patterns of chronic stroke patients with hemiparetic gait
Evaluation of the effect of action observation on kinetic and kinematic parameters of gait using a gait analysis system and QEEG-based cortical brain activity in patients with chronic stroke
Design
30 patients with chronic stroke will be randomly allocated to the experimental and sham control groups using opaque envelopes randomization method. Each group will receive intervention three times a week for four weeks.
Settings and conduct
Gait analysis will be done in the biomechanics center of rehabilitation school and QEEG acquisition, physical training, and action observation training will be done in the neuroscience laboratory of Advanced Medical Sciences and Technologies of Shiraz University of Medical Sciences. The patients, the assessors, and the therapist would be blinded.
Participants/Inclusion and exclusion criteria
Patients with unilateral stroke who have hemiparetic gait will be recruited in the study. The patients must be able to walk at least 10 meters independently. Both right-handed males and females will be included. In case of the presence of any other disorders including visual impairment, orthopedic, or other neurological disorders or depression they will be excluded.
Intervention groups
The experimental group will watch a video depicting actions commonly used for improvement of walking ability of patients with stroke and subsequently will practice the same actions with the help of an experienced therapist. The control group will watch a video depicting landscapes and after that will practice the same actions done by the experimental group.
Main outcome variables
Gait parameters, including spatiotemporal parameters, joint angles and moments and also connectivity map of cortical motor areas and inter-hemispheric asymmetry of different brain frequency bands would be recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041333N1
Registration date:2020-09-01, 1399/06/11
Registration timing:retrospective
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Fatemeh Shamsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5262 2836
Email address
f.shamsi86@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of action observation training on kinetic and kinematic parameters of gait and quantitative electroencephalography (qEEG) patterns of chronic stroke patients with hemiparetic gait
Public title
Action observation training for the improvement of walking ability in patients with chronic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic stroke > 6 months after onset
In the territory of the middle cerebral artery (MCA)
Hemiparetic gait
First stroke experience
Unilateral lesion
Walking at least 10 meter independently
mRS : 2-3
Ashworth Scale :1,2
Right/ left hemiparesis
Right-handed
Literate enough to cooperate with the therapist
Residence in Shiraz
Exclusion criteria:
Any other neurological disorder rather than stroke or any orthopedic disorder
Visual field impairment
Hemineglect
Depression
Cognitive disorder /<24 on MMSE
The history of Botox injection
The history of tendon lengthening surgery
The history of seizure
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using opaque envelopes. In this method, clinicians are given randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter a trial an envelope is opened and the patient is then offered the allocated treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, physical therapist and assessors will be blinded in this study by recruiting a person to assess the outcomes and a different one to provide physical training and another person for implementation action observation training
Placebo
Used
Assignment
Other
Other design features
A randomized controlled trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Shiraz university of medical sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.SUMS.REC.1397.564
Health conditions studied
1
Description of health condition studied
Chronic stroke resulting in hemiparetic gait
ICD-10 code
164
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Kinetic and kinematic parameters of gait
Timepoint
Before intervention and after a 4-week intervention
Method of measurement
gait analyzing system
2
Description
Delta-alpha ratio
Timepoint
Before intervention and after a 4-week intervention
Method of measurement
Quantitative Electroencephalography
Secondary outcomes
1
Description
Balance
Timepoint
Before intervention and after a 4-week intervention
Method of measurement
Berg Balance Scale
Intervention groups
1
Description
Intervention group: the group that watches videos depicting actions commonly used for the improvement of walking ability of patients with hemiparesis
Category
Rehabilitation
2
Description
Control group: the group that watches videos depicting landscapes without any moving content
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuroscience Labratory of Advanced Medical Sciences and Technology
Full name of responsible person
Dr. Mohammad Nami
Street address
Ghasrodasht
City
Shiraz
Province
Fars
Postal code
7194684560
Phone
+98 71 3230 5471
Email
pajouhesh_novin@sums.ac.ir
2
Recruitment center
Name of recruitment center
Biomechanic research center of rehabilitation science school
Full name of responsible person
Dr. Mohammad Taghi Karimi
Street address
Chamran avenue, Abiverdi 1
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
MT_Karimi@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Zand street
City
shiraz
Province
Fars
Postal code
14336-71348
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shamsi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Ghasrodasht street, School of Advanced Medical Sciences and Technology
City
Shiraz
Province
Fars
Postal code
14336-71348
Phone
+98 71 3230 5471
Email
f.shamsi86@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shamsi
Position
Phd. Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Lane 29, Ghasrdasht street, Shiraz
City
Shiraz
Province
Fars
Postal code
7194684560
Phone
+98 71 5262 2836
Fax
Email
F.shamsi86@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shamsi
Position
PhD. candidate
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Lane 29, Ghasrdasht street, Shiraz
City
Shiraz
Province
Fars
Postal code
7194684560
Phone
+98 71 5262 2836
Fax
Email
F.shamsi86@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified data for the primary outcome measures can be shared
When the data will become available and for how long
The documents/data files will become available at least 3 months after the article is published and it will be available for at least 6 months
To whom data/document is available
The deidentified IPD and any additional supporting information/documents will be available only for people working in academic institutions
Under which criteria data/document could be used
People must let the researcher know what they want to do for this data and get permission for any use
From where data/document is obtainable
The applicant can get these documents or data files by sending an email to the corresponding author of the related article. the email address will be available in the published article
What processes are involved for a request to access data/document
The applicant must give the corresponding author the reason for which he/she needs the data and the corresponding author will let other authors know about the request and will send the data to the applicant if all authors agree with this work. it may take at least two weeks