Triple stimulation using visual-auditory sensory stimulation in patients with hemineglect , following right sided stroke and its efficacy :a prospective study.
- Conditions
- Patients with right hemispheric ischemic stroke, who has left sided hemineglect
- Registration Number
- CTRI/2018/05/014232
- Lead Sponsor
- Dr Sesh S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 20
- 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.
1.Hemorrhagic stroke 2.Impaired level of consciousness or significant aphasia 3.NIHSS >20.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Improvement in stroke score ( modified Rankin score), muscle power . Modified Primary outcome variables will be measured at 1 month and 3 months follow up.
Trial Locations
- Locations (1)
Sree Chitra Institute of Medical Sciences and Technologyh
🇮🇳Thiruvananthapuram, KERALA, India
Sree Chitra Institute of Medical Sciences and Technologyh🇮🇳Thiruvananthapuram, KERALA, IndiaDr Sesh SPrincipal investigator9995210020seshs2010@gmail.com