| CTRI Number |
CTRI/2021/02/031440 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| 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
|
Coma arousal program for severe head injury patients |
|
Scientific Title of Study
|
Safety, Feasibility and Efficacy of
Subject Specific Integrated Multi-Sensory Stimulation Program
For Patients with Severe Traumatic Brain Injury in Acute setup
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarsi Shah |
| Designation |
PhD scholar |
| Affiliation |
School of Physiotherapy ,R K University |
| Address |
RK University, Bhavnagar Highway, Kasturbadham, Rajkot, Gujarat
Rajkot
GUJARAT
360001
India |
| Phone |
9265719216 |
| Fax |
|
| Email |
aarsishah007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarsi Shah |
| Designation |
PhD scholar |
| Affiliation |
School of Physiotherapy ,R K University |
| Address |
RK University, Bhavnagar Highway, Kasturbadham, Rajkot, Gujarat
Rajkot
GUJARAT
360001
India |
| Phone |
9265719216 |
| Fax |
|
| Email |
aarsishah007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanshu Rathod |
| Designation |
Professor & Dean |
| Affiliation |
School of physiotherapy R K University |
| Address |
School of Physiotherapy, RK University, Rajkot
Faculty of Medicine; School of Physiotherapy, RK University, Rajkot.
Rajkot
GUJARAT
360020
India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| (Self)
Aarsi Shah
Phd scholar
RK University Rajkot-Gujarat -India |
| Department of Neurosurgery
Wockhardt hospitals
Rajkot |
| Gokul hospital ,Rajkot |
| Sanganis Multispeciality Hospital-Keshod -Gujarat-India |
| School of Physiotherapy
Faculty of Medicine
RK University-Rajkot-Gujarat India |
|
|
Primary Sponsor
|
| Name |
Aarsi Shah |
| Address |
School of Physiotherapy, RK University, Rajkot Bhavnagar Road, Kasturbadham, Trumba, Rajkot - 360020.Gujarat India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gokul hospital |
12/14 vidyanagar main road,Bhaktinagar Rajkot |
| Sanganis Multispeciality Hospital |
Keshod -Gujarat-India |
| School Of physiotherapy RK University |
Rajkot Gujarat |
| Wockhardt Hospitals |
Wockhardt hospitals -Rajkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJigarsinh Jadeja |
Gokul Hospital |
GOKUL Hospital
(Gokul superspeciality hospital managed by Gokul Lifecare Pvt. Ltd.),
Vidyanagar Main Road,Rajkot
Rajkot
GUJARAT |
9687693601
drjadejaneuro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, School of Physiotherapy, RK University, Rajkot 360020, Gujarat, India |
Approved |
| The Ethical Committee (School of Physiotherapy, RK University), recognized by the Central Drug Standard Control Organization (CDSCO), Govt. of India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multimodal sensory stimulation |
Various stimuli(auditory/visual/tactile/proprioceptive/gustatory/vestibular) or any 1 stimuli will be administered to patients for 45 minutes thrice a day for 14 days with severe traumatic brain injury in acute setup |
| Intervention |
Subject specific integrated multi sensory stimulation program (SSIMS) |
Subject Specific Integrated Multi-Sensory Stimulation Program (SSIMS) is a newly structured stimulation program comprising the Personal, recreational and professional components of a subject’s daily life into treatment plan delivered through multiple sensory channels in an integrated manner in functional position with added personal salience |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-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
|
|
| ExclusionCriteria |
| Details |
-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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coma recovery scale- revised |
Baseline, everyday till day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2021 |
| Date of Study Completion (India) |
14/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |