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
|
|
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
|
|
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
|
|
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. |