The Effect of Auditory Spatial Attention Training on Auditory Spatial and Dichotic Processing in Subjects with Right Brain Stroke
Design
controlled clinical trial, sample size based on the pilot study: 8 subjects in each group
Settings and conduct
Research site: Rofeideh rehabilitation hospital, initial evaluation for inclusion criteria: obtaining a consent form, examination by a neurologist, conducting Mini Mental State Examination (MMSE) test, Edinburgh questionnaire, auditory spatial and dichotic tests, and SSQ questionnaire, Allocation to intervention and control groups by block randomization, intervention group: under 12 sessions of auditory lateralization training, outcome evaluation by auditory spatial and dichotic tests and SSQ questionnaire
Participants/Inclusion and exclusion criteria
Consent to participate in the study; Right Hemisphere Stroke; Stability of the Medical Condition; Lack of Other Neurological Diseases; Minimum Score of 21 in MMSE; Right Handedness, Normal Hearing
Intervention groups
Intervention group: receive 12 sessions of auditory lateralization training, the control group: they do not receive interventions.
Main outcome variables
Improving auditory spatial skills including auditory lateralization and divided attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221016056197N1
Registration date:2023-01-29, 1401/11/09
Registration timing:prospective
Last update:2023-01-29, 1401/11/09
Update count:0
Registration date
2023-01-29, 1401/11/09
Registrant information
Name
Zahra Eshaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0066
Email address
zah.eshaghi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Auditory Spatial Attention Training on Auditory Spatial and Dichotic Processing in Subjects with Right Brain Stroke
Public title
Auditory Spatial Attention Training in Stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Right Hemisphere Stroke Diagnosed by a Neurologist
Unilateral Spatial Neglect Diagnosed by a Neurologist
Stability of the Medical Condition after the Acute Phase of Stroke
Right-Handedness
Normal Hearing (Average Hearing Thresholds of Frequencies 500, 1000 and 2000 Hz Less Than 25 dB HL in Both Ears and Symmetrical Hearing)
Exclusion criteria:
Other Neurological Diseases
Cognitive Problems Based on Persian version of Mini–Mental State Examination (MMSE) (Minimum Score of 21)
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, we will use 8 cards A (treatment group) and 8 cards B (control group) and put them in 16 envelopes with the same shape that is not clear inside them. After reshuffling them several times, we will mark them whit serial numbers from 1 to 16. when each participant enters, an envelope is opened and the patient group is determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study will investigate a number of stroke patients in two groups. One group (intervention group) receives rehabilitation and the other group (control group) don't receive any intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
Koudakyar St., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.USWR.REC.1398.193
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
stroke
ICD-10 code description
stroke
Primary outcomes
1
Description
Number of auditory lateralization errors
Timepoint
Before the intervention, after the last session (0 to 48 hours after the last session) and one month later
Method of measurement
Interaural Time and Intensity Difference (ITD and IID) auditory lateralization test
2
Description
Spatial monosyllabic word recognition score in noise
Timepoint
Before the intervention, after the last session (0 to 48 hours after the last session) and one month later
Method of measurement
Auditory lateralization of monosyllabic words in noise test
3
Description
Right and left ear scores in Randomized Dichotic Digit Test (RDDT)
Timepoint
Before the intervention, after the last session (0 to 48 hours after the last session) and one month later
Method of measurement
Persian version of randomized dichotic digit test
4
Description
Laterality index in Randomized Dichotic Digit Test (RDDT)
Timepoint
Before the intervention, after the last session (0 to 48 hours after the last session) and one month later
Before the intervention, after the last session (0 to 48 hours after the last session) and one month later
Method of measurement
Speech , Spatial , Quality of Hearing Scale (SSQ) questionnaire
6
Description
Number of auditory lateralization errors
Timepoint
Before the intervention, after the last session (0 to 48 hours after the last session) and one month later
Method of measurement
Auditory lateralization of monosyllabic words in noise test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: auditory lateralization training is performed for 12 sessions of 45 minutes. Auditory stimulus is high-pass and low-pass noise with a cut-off frequency of 2 kHz, which were simulated in 9 hypothetical spatial locations (in the form of 9 speakers in a semicircular horizontal plane) by interaural time difference (ITD) under MATLAB software. The sounds were presented binaurally with different ITDs (0, ±220, ±440, ±660 and ±880 microseconds) at comfortable level via headphones, to induce a sense of displacement of the sound source. Positive and negative numbers and zero indicate stimulus presentation from the right and left angles, and center position, respectively. The subjects should lateralize the sounds and point to a schematic picture of speakers in front of them with right hand.
Category
Rehabilitation
2
Description
Control group: they do not receive any intervention.