1. Home
  2. Approved trials
  3. » فارسی

Evaluation of therapeutic effect of Kalimba music on cognitive, speech and motor rehabilitation of patients with ischemic stroke

Protocol summary

Study aim
Investigating the therapeutic effect of kalimba music on cognitive, speech and motor rehabilitation of patients with ischemic stroke
Design
Clinical trial, with control group, with parallel groups, without blinding, phase 0 on 620 patients. The rand function of Excel software was used for randomization.
Settings and conduct
We are considering that the music therapy process of the patients will take place within 4-5 months (16 half-hour sessions) in the office of a neurologist. The control group will continue with the predetermined treatments in the medical system, including drug therapy, physical therapy, speech therapy, occupational therapy, and rehabilitation. The experimental group will also use music therapy as a complementary (and not a substitute) treatment in addition to the aforementioned treatment methods.
Participants/Inclusion and exclusion criteria
Society: People with ischemic stroke in the anterior and middle cerebral artery less than 1 year have passed since their stroke and have complications such as speech disorder, half body paralysis, depression and cognitive complications; The age of these people is in the range of 55 to 75 years and they have the same risk factors and drugs.
Intervention groups
An educational program including playing the kalimba instrument with very simple rhythms in the initial sessions to playing more complex rhythms for the final sessions will be developed and will be taught to the patients. The patient will play these rhythms (including the repetition of 4-20 notes) in the presence of the therapist's music during therapy sessions. The control group will receive only the usual methods included in the treatment protocol, including drug therapy, physical therapy, rehabilitation, and speech therapy.
Main outcome variables
music therapy؛ stroke؛ playing؛ Kalimba؛ cognitive؛ speech؛ anterior cerebral artery؛ ischemic stroke

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240120060743N1
Registration date: 2024-02-16, 1402/11/27
Registration timing: retrospective

Last update: 2024-02-16, 1402/11/27
Update count: 0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
Mahdieh Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2246 7419
Email address
mahdiye.dehghan1379@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
2022-05-22, 1401/03/01
Actual recruitment end date
2023-12-22, 1402/10/01
Trial completion date
2024-01-10, 1402/10/20
Scientific title
Evaluation of therapeutic effect of Kalimba music on cognitive, speech and motor rehabilitation of patients with ischemic stroke
Public title
Evaluation of therapeutic effect of Kalimba music on cognitive, speech and motor rehabilitation of patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with ischemic stroke in the anterior and middle cerebral artery. Less than 1 year has passed since their stroke. They suffer from complications such as speech disorder, paralysis of half of the body, depression and cognitive complications. The age of these people is between 55 and 75 years. They have the same risk factors and drugs.
Exclusion criteria:
have been infected with covid 19 before the stroke. Patients do not have enough information to fill out the questionnaire. Patients who have severe movement disorders that cannot hold and play the instrument.
Age
From 55 years old to 75 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 620
Actual sample size reached: 620
Randomization (investigator's opinion)
Randomized
Randomization description
First, a list of all people was prepared based on the entry and exit criteria. Each patient was assigned a number and then by Excel software, the patients were randomly divided into two groups (intervention group and control group). In addition to the standard treatment, music was performed for the patients in the intervention group, and only the standard treatment was prescribed for the control group.
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
Tehran Islamic Azad University of Medical Sciences
Street address
No 17, Yaran B , Emam sajad Ave, Shahed Blvd
City
Tehran
Province
Tehran
Postal code
1955777683
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.IAU.TMU.REC.1401.001

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
164
ICD-10 code description
Cerebrovascular accident NOS

Primary outcomes

1

Description
Score in NIHSS questionnaire ؛ Score in specific quality of life questionnaire of stroke patients - William et al. (1999)
Timepoint
At the beginning of the study and 5 months after the start of music therapy
Method of measurement
NIHSS questionnaire and specific quality of life questionnaire for stroke patients - William et al. (1999)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: NIHSS test was taken in this group at the beginning of the study. Then, 12 to 16 music therapy sessions, including playing the kalimba instrument, hand and foot movements, and saying different sounds along with hearing certain notes from the kalimba instrument, were performed for 3 to 4 months. At the end of the exercises of the last session, the NIHSS test was again taken from the patients.
Category
Treatment - Devices

2

Description
Control group: In this group, at the beginning of the study, the NIHSS test was taken from the patients. Then the patients received routine drug and physiotherapy and speech therapy treatments for 3 months and were followed up. After three months, the NIHSS test was again taken from the patients and its changes were compared with the intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology office of Dr. Radnoosh Pashmforush
Full name of responsible person
Dr Radnoosh Pashmforush
Street address
third floor, jam building, Farahzadi Blvd
City
Tehran
Province
Tehran
Postal code
1467773666
Phone
+98 21 4219 8348
Email
mahdiye.dehghan1379@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Gholamzad
Street address
Islamic Azad University of Medical Sciences, Tehran branch, Khagani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Radnoosh Pashmforoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Jam building, Next to Atieh Hospital, Farahzadi Blvd
City
Tehran
Province
Tehran
Postal code
1467773666
Phone
+98 21 8857 4483
Email
Drp922@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Radnoosh Pashmforoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Jam building, Next to Atieh Hospital, Farahzadi Blvd
City
Tehran
Province
Tehran
Postal code
1467773666
Phone
+98 21 8857 4483
Email
Drp922@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Radnoosh Pashmforoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Jam building, Next to Atieh Hospital, Farahzadi Blvd
City
Tehran
Province
Tehran
Postal code
1467773666
Phone
+98 21 8857 4483
Email
Drp922@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In the informed consent form, it is mentioned that the personal information of the patients will not be published.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...