Coma arousal program for severe head injury patients
- Conditions
- Disorder of brain, unspecified,
- Registration Number
- CTRI/2021/02/031440
- Lead Sponsor
- Aarsi Shah
- Brief Summary
Patients will be screened depending upon the inclusion criteria. Informed consent to participate in the study shall be taken from the guardian of the patients. Provision for re-consent will be made once the patient is cognitively capable. The patients will be allocated to 2 groups ie) control group and experimental group. A block randomization method will be used for allocation.
Control group will be administered with the conventional coma arousal technique that uses various stimuli viz.) music for auditory stimulation, photos for visual stimulation, touch for tactile stimulation, familiar smell as olfactory stimulation, etc. single stimuli or a combination of them will be used.
The experimental group will be administered with the newly developed therapy –“subject-specific integrated multisensory stimulation program†A detailed history about likes and dislikes of the patients will be taken on 3 domains 1) personal, professional and recreational. Depending upon it, a functional task will be made for the patient that includes various stimuli like auditory, tactile, proprioceptive, gustatory, etc. taking into consideration its feasibility Various functional tasks that include all the stimuli or a combination of them will be used for the patient.
The duration of treatment will be the same for both the groups – 45 minutes thrice a day for 14 days. Vitals, GCS, ABS, FOUR, CRS-R, DOCS-25 will be taken at the time of admission, every day as a form of reassessment till the 14th day. Length of stay and GOS-E scores shall be taken at the time of discharge.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event -Stable hemodynamic (absence of dangerous variations of Mean Arterial Pressure or Heart Rate -Admitted to the neurosurgical unit -Approval of treating physician.
History of prior brain injury -Premorbid history of uncorrected visual or hearing impairments -Premorbid history of developmental, psychiatric, or neurologic illness resulting in documented functional disability up to the time of the injury -Coma or persistent vegetative state not caused by TBI -Acute medical illness -Medical complications during the study -Active Otorrhoea or Rhinorrhoea.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Coma recovery scale- revised Baseline, everyday till day 14
- Secondary Outcome Measures
Name Time Method Rancho los amigos scale RLA baseline,everyday till day 14 GCS Baseline, everyday till day 14 Agitated behavioral scale baseline, everyday till day 14 Disorders of consciousness scale DOCS-25 Baseline,everyday till day 14 Glasgows outcome scale extended (GOS-E) On discharge/on 14th day Length of stay (in days) At discharge The Full Outline of UnResponsiveness (FOUR) score scale baseline,everyday till 14th day
Trial Locations
- Locations (1)
Gokul Hospital
🇮🇳Rajkot, GUJARAT, India
Gokul Hospital🇮🇳Rajkot, GUJARAT, IndiaDrJigarsinh JadejaPrincipal investigator9687693601drjadejaneuro@gmail.com