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Evaluation of the effectiveness of speech therapy interventions and Arm Ability Training (AAT) on naming skill, sentence comprehension, memory and hand dexterity in people with mild to moderate aphasia

Protocol summary

Study aim
Evaluation of naming skill, sentence comprehension, memory and hand dexterity scores after performing two different treatment protocols in people with mild to moderate aphasia
Design
Clinical trial without a control group, with parallel groups, double-blinded, randomized on 45 patients. A random number table will be used for randomization.
Settings and conduct
Samples will be patients with aphasia of Ghaem hospital in Mashhad who will be randomly divided into three groups of fifteen. The first group will receive protocol "A" including speech therapy, the second group will receive protocol "B" including Arm Ability Training and the third group will receive protocol "A" and "B" simultaneously. The study is double-blinded including evaluators and analysts.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of the lesions in the frontal and temporal lobes of the left hemisphere/ Confirmation of impairment in language skills and motor weakness in the right hand Exclusion criteria: Presence of psychiatric symptoms
Intervention groups
First group: speech therapy Second group: Arm Ability Training Third group: speech therapy and Arm Ability Training simultaneously
Main outcome variables
1) The changes rate in naming skill, sentence comprehension, memory and hand dexterity before and after implementing the treatment protocol 2) The changes rate in naming skill, sentence comprehension, memory and hand dexterity during the first and second weeks of study in each group 3) Comparison of changes in naming skill, sentence comprehension, memory and hand dexterity during the first and second weeks of study between groups 4) Examine the process of changes in naming skill, sentence comprehension, memory and hand dexterity of each week studied in each group 5) Compare the process of changes in naming skill, sentence comprehension, memory and hand dexterity of each week studied between groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200114046134N1
Registration date: 2020-07-29, 1399/05/08
Registration timing: prospective

Last update: 2020-07-29, 1399/05/08
Update count: 0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Reihane Sabermoghadam Majidzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3763 6953
Email address
sabermr971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of speech therapy interventions and Arm Ability Training (AAT) on naming skill, sentence comprehension, memory and hand dexterity in people with mild to moderate aphasia
Public title
Evaluation of the effectiveness of speech therapy and Arm Ability Training (AAT) in aphasia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of lesion in frontal and temporal lobes of left hemisphere using Magnetic Resonance Imaging (MRI) findings of brain/ The right hand is the recipient/ Confirmation of impairment in language skills (comprehension and expression) through speech therapy using aphasia test of Dr Nilipour/ Mild to moderate confirmation of aphasia by speech therapy using Dr Nilipour aphasia test/ Mild to moderate of mental status by MiniMental Status Evaluation (MMSE) test/ Assessment of right-hand motor weakness by a physiotherapist/ At least one month to two years after stroke/ Patients with age spectrum 35-70/ Patients' satisfaction and willingness to enter the study
Exclusion criteria:
Severe upper extremity disorders/ Psychiatric symptoms such as mood and emotional disorders, sleep disorders, depression, cognitive disorders, etc./ Chronic liver, kidney and heart disease/ Progressive diseases/ Subsequent strokes/ Patient non-cooperation
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, due to the inability to hide the type of treatment from the samples and therapists, evaluators will not know the type of treatment that samples receive when assessing the skills before the start of treatment and on days 7,14 and 21 after starting treatment. Analysts will also not know the type of treatment that samples receive when analyzing the data from the evaluation of the skills.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Across the No. 18 ,Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.MUMS.REC.1399.363

Health conditions studied

1

Description of health condition studied
aphasia
ICD-10 code
R47.01
ICD-10 code description
Aphasia

Primary outcomes

1

Description
score of naming skill
Timepoint
Before starting the intervention and 7,14 and 21 days after starting the treatment
Method of measurement
Subtest of picture naming from Dr. Nilipour's set of aphasia batteries

2

Description
Score of sentences comprehension
Timepoint
Before starting the intervention and 7,14 and 21 days after starting the treatment
Method of measurement
Subtest of sentences comprehension from a Bilingual Aphasia Test (BAT)

3

Description
Score of memory skill
Timepoint
Before starting the intervention and 7, 14 and 21 days after starting treatment
Method of measurement
Wechesler test

4

Description
Hand dexterity
Timepoint
Before starting the intervention and 7, 14 and 21 days after starting treatment
Method of measurement
Test d'Evaluation des Membres suprrieurs des Personnes Agres (TEMPA)

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: nine sessions of speech therapy and each session lasts for 40 minutes. After evaluating the patient, each of the different levels of language, including semantics, phonology, morphology and syntax, reading and writing is targeted according to the degree of damage in each person.
Category
Rehabilitation

2

Description
Second intervention group: nine sessions of Arm Ability Training (AAT) and each session lasts for 40 minutes. Due to the individual limitations, eight-step exercises are performed with the aim of increasing speed, accuracy and coordination.
Category
Rehabilitation

3

Description
Third intervention group: nine speech therapy and Arm Ability Training (AAT) are simultaneous, 20 minutes of speech therapy sessions and 20 minutes of Arm Ability Training sessions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology clinic of Ghaem hospital
Full name of responsible person
Sobhani-rad Davood
Street address
Paramedicine school, Mashhad University of Medical Scients
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
SobhaniD@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohsen tafaghodi
Street address
Across the No. 18 , Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reihane Sabermoghadam Majidzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 15 , Samane Ave. Ferdowsi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9197989735
Phone
+98 51 3763 6953
Fax
Email
sabermr971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sobhani-rad Davood
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Paramedicine school, Mashhad University of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6715
Fax
Email
SobhaniD@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihane Sabermoghadam Majidzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 15 , Samane Ave. Ferdowsi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9197989735
Phone
+98 51 3763 6953
Fax
Email
sabermr971@mums.ac.ir

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
There is no more information
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
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