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CTRI Number  CTRI/2018/05/014232 [Registered on: 30/05/2018] Trial Registered Retrospectively
Last Modified On: 31/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Triple stimulation using visual-auditory sensory stimulation in patients with hemineglect , following right sided stroke and its efficacy :a prospective study. 
Scientific Title of Study
Modification(s)  
Effect of combined visual-auditory-sensory stimulation in hemineglect syndrome following right hemispheric ischemic strokes: a randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sesh S 
Designation  Senior Resident 
Affiliation  Sree Chitra Tirunal Institute of Medical Sciences and Technology 
Address  Department of Neurology Sree Chitra Tirunal Institute of Medical Sciences and Technology
Chempakom House No :3 Tagore Gardens Medical College P.O Trivandrum
Thiruvananthapuram
KERALA
695011
India 
Phone  9995210020  
Fax    
Email  seshs2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sajith S 
Designation  Additional Professor  
Affiliation  Sree Chitra Tirunal Institute of Medical Sciences and Technology 
Address  Department of Neurology Sree Chitra Tirunal Institute of Medical Sciences and Technology
Department of neurology SCTIMST Trivandrum 695011
Thiruvananthapuram
KERALA
695011
India 
Phone  9947488294  
Fax    
Email  sajith@sctimst.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sesh S 
Designation  Senior Resident 
Affiliation  Sree Chitra Tirunal Institute of Medical Sciences and Technology 
Address  Department of Neurology Sree Chitra Tirunal Institute of Medical Sciences and Technology

Thiruvananthapuram
KERALA
695011
India 
Phone  9995210020  
Fax    
Email  seshs2010@gmail.com  
 
Source of Monetary or Material Support  
No monetary support 
 
Primary Sponsor  
Name  Dr Sesh S 
Address  Chempakom House No :3 Tagore Gardens Medical College .P.O Trivandrum 
Type of Sponsor  Other [Individual ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sesh S  Sree Chitra Institute of Medical Sciences and Technologyh  Department of Neurology SCTIMST, Trivandrum 695011
Thiruvananthapuram
KERALA 
9995210020

seshs2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SCTMIST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with right hemispheric ischemic stroke, who has left sided hemineglect,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Control group patients recieve only routine standard physiotherapy as per hospital protocol  Control group patients recieve only routine standard physiotherapy as per hospital protocol 
Intervention  DURATION OF INTERVENTION  Duration of therapy : total one month .. follow up at 1 month and 3 months. 
Intervention  Stimulate patients with hemineglect using visual stimuli ( optokinetic drum), cutaneous sensory stimuli ( alarm bell) and auditory stimuli( using music played from a mobile phone)  Stimulate patients with hemineglect using visual stimuli ( optokinetic drum), cutaneous sensory stimuli ( alarm bell) and auditory stimuli( using music played from a mobile phone) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients within 2 weeks following acute right MCA territory ischemic stroke with clinical features suggestive of visual and or sensory neglect.
2. Fully conscious oriented without any significant aphasia (should have normal/useful level of comprehension and communicative capabilities).
3. Age>18 and <80
 
 
ExclusionCriteria 
Details  1. Hemorrhagic stroke
2. Impaired level of consciousness or significant aphasia
3. NIHSS >20
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Hemineglect as measured by neuropsychological tests ( star cancellation, line bisection, picture identification, clock drawing ).  Primary outcome variables will be measured at 1 month and 3 months follow up.
Neuropsychological tests will be applied to assess the improvement 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in stroke score ( modified Rankin score), muscle power .  Modified Primary outcome variables will be measured at 1 month and 3 months follow up.
Neuropsychological tests will be applied to assess the improvement 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/06/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The proposed study is a hospital based, randomized controlled interventional clinical trial, to study the effect of combined visual-auditory-sensory stimulation in addition to standard physiotherapy in patients with left sided hemi neglect resulting from right hemispheric ischemic strokes. The effect of intervention on the hemineglect as well as on the neurological and functional outcome in the intervention group at specified intervals will be compared with those who have received the standard physiotherapy alone (control group).

Prior to intervention, baseline clinical demographic details will be collected and patients will be clinically examined for the presence of visual and sensory inattention as well as NIHSS and mRS score. Hemineglect is assessed and quantified using the following standardized neuropsychological tests namely Line Bisection Test, Star Cancellation Test, Picture Identification Test and Clock Drawing Test, prior to intervention.

Control group receives conventional physiotherapy, whereas intervention group receives triple therapy in addition to conventional physiotherapy. The therapy is initiated within 2 weeks of stroke onset, when patients become clinically stable enough and become able to understand and cooperate with the intervention.Half an hour sessions, twice daily for at least 3 consecutive days prior to discharge will be scheduled (details mentioned below). At discharge from the hospital, patients/ care givers will be trained to continue daily therapy sessions at home (details of home therapy sessions mentioned below).

Compliance and adherence to therapy sessions will be prompted and ascertained by the investigators through weekly phone calls. The primary outcome parameter (improvement in hemineglect)and secondary outcome parameters (changes in Neurological and Functional status) are assessed using the aforesaid neuropsychological tests and NIHSS and mRS scores respectively at the end of 1 month and 3 months post intervention.The mean changes in test values are compared between study group and control group to look for any statistically significant improvement.

Interventions:

Triple therapy: Patients are presented with visual stimulus on a 17” PC monitor or using a standard optokinetic drum. Patients are instructed to look at computer-generated random display of a single blinking bright spot or an appropriate visual target moving from right towards left (contralesional hemispace) with a speed of 10 degree/sec.  On reaching the left end of the screen, patient is required to press a switch of a bell, kept on the left side of the patient with his left hand for five seconds (with help if left hand is too weak). If following this, a cutaneous stimulus is given (using functional electrical stimulator on the left hand/left shoulder).  Following this, a cutaneous stimulus is given (using functional electrical stimulator on the left hand/left shoulder). If the patient fails to accomplish the motor task, the cutaneous stimulus will be repeated for maximum five times. Auditory stimulus will be given as constant music (Beethoven symphony 9 second movement), which will be played from the left side of the patient throughout the testing period as well as during testing as vocal commands (involved in the testing) from the examiner , from the neglected side of the patient. The cycle is repeated 10 times in each setting.

 

Home therapy sessions: At discharge from the hospital, patient and caregiver will be trained about the home therapy sessions (20-30 minute sessions, twice daily). During each session, auditory stimulus will be given as constant music (Beethoven symphony 9, 2ndmovement), which will be played from the left side of the patient with the help of electronic music player or mobile phone.Visual stimulation will be provided through optokinetic drum, towards the left hemifield for 30 seconds. At the end of 30 sec, patient is asked to do motor tasking.Patient is required to press a switch of a bell which is kept on the left side of the patient with his left hand for ten seconds (with help if left hand is too weak).The vibration of the bell will indirectly give cutaneous stimulus to the patient.  Each cycle is repeated for total duration of 20-30 minutes. Each session is repeated two times a day for one month after discharge.  Patients will be provided with a log book in which details of daily home sessions and duration will be given clearly.

 
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