Using Neurologic Music Therapy in cognitive rehabilitation of stroke patients and comparing the effectiveness of this intervention with standard rehabilitation procedures
Design
In this research, 30 eligible stroke patients who have been referred to a public hospital are chosen purposefully and are matched in two control and experiment groups according to their gender.
Settings and conduct
Study place: Firoozgar Hospital.
Intervention: fifteen sessions, 2 sessions a week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Experience of an ischemic stroke
2- It's no more than 2 years after the stroke
3- Impairments in attention, memory and executive functions due to stroke have been observed
Exclusion criteria:
1- History of mental disorders (except for post-stroke depression)
2- History of any brain injuries other than stroke
3- Mental retardation
4- History of drug or alcohol abuse
Intervention groups
1) Experiment group: Neurologic music therapy in addition to standard rehabilitation intervention. 2) Control Group: standard rehabilitation intervention
Main outcome variables
Attention; Memory; Executive Functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110807007250N2
Registration date:2018-02-09, 1396/11/20
Registration timing:registered_while_recruiting
Last update:2018-02-09, 1396/11/20
Update count:0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
bijan forogh
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
bforough@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the Effectiveness of Neurologic Music Therapy on Cognitive Rehabilitation of Stroke Patients
Public title
Effect of NMT on Cognitive Capabilities of Stroke Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants have experienced an ischemic stroke
It's no more than 2 years after their stroke
Impairments in attention, memory and executive functions due to stroke have been observed
Exclusion criteria:
History of mental disorders (except for post-stroke depression)
History of any brain injuries other than stroke
Mental retardation
History of drug or alcohol abuse
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)
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 Iran University of Medical Sciences
Street address
Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-08, 1396/09/17
Ethics committee reference number
IR.IUMS.REC1396.31141
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Attention
Timepoint
Before, in the middle of and after the intervention, and in a 3 month follow-up
Method of measurement
Montreal Cognitive Assessment
2
Description
Memory
Timepoint
Before, in the middle of and after the intervention, and in a 3 month follow-up
Method of measurement
Montreal Cognitive Assessment
3
Description
Executive functions
Timepoint
Before, in the middle of and after the intervention, and in a 3 month follow-up
Method of measurement
Montreal Cognitive Assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neurologic Music Therapy. 15 sessions of NMT intervention, 2 sessions a week. These sessions will be held in the hospital using simple percussion instruments and recorded music pieces. In this study 8 therapeutic techniques will be performed, as described in NMT Manual.
Category
Rehabilitation
2
Description
Control group: Standard rehabilitation interventions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Sara Eskandary
Street address
Beh Afarin Ave., Karim Khan Zand St., Vali-e Asr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
sa62ir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malakooti
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Bijan Forough
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Ali Valadi Ave., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
bforough@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forough
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Valadi Ave., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
bforough@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forough
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Valadi, Ave., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
bforough@tums.ac.ir
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