| CTRI Number |
CTRI/2017/09/009599 [Registered on: 01/09/2017] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to develop and test the effects of Meaningful Coma arousal technique after Accidental Brain Injury |
|
Scientific Title of Study
|
Developing and Testing of Meaningful Multimodal
Sensory Stimulation in patients with Coma following Traumatic Brain Injury |
| 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 |
MPT student |
| Affiliation |
School of Allied Health Science Manipal University Manipal |
| Address |
Uttam 5 Narmadapark Society Amin Marg Rajkot 360001
Rajkot
GUJARAT
360001
India |
| Phone |
9662055981 |
| Fax |
|
| Email |
aarsishah007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJohn Solomon |
| Designation |
Associate professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy, School of Allied Health Sciences,
Manipal University, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrN Manikandan |
| Designation |
Associate professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy, School of Allied Health Sciences,
Manipal University, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Aarsi Shah
MPT neurosciences
School of Allied Health Science SOAHS
Manipal -576104
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Aarsi Shah |
| Address |
PG student, Department of Physiotherapy, SOAHS, Manipal University,
Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Aarsi Shah |
Kasturba Hospital |
Baliga Block
Dhanwantri ward opposite to renal transplant unit
3dh floor
Ward number: DV1,DV2
Manipal
Udupi
KARNATAKA |
9662055981
aarsishah007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC KHIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, Traumatic Brain Injury , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meaningful Multimodal Sensory stimulation |
Various Meaningful Stimuli (auditory,tactile,gustatory,vestibular,proprioceptive,visual)will be given in a functional position to patients and their Arousal will be measured by SSAM and CRS-R scales |
| Comparator Agent |
Multimodal sensory stimulation |
Various stimuli(auditory/visual/tactile/proprioceptive/gustatory/vestibular) or any 1 stimuli will be administered to patients with coma following traumatic brain injury and their arousal will be measured by CRS-R and SSAM scales |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Who are haemodynamically stable and shifted out of ICU, have a GCS score less than 8, and minimum of 48 hours after surgery or conservative management. |
|
| ExclusionCriteria |
| Details |
Who have a previous history of Brain Damage,known case of impaired vision and hearing,active Otorrhoea or Rhinorrhea (signs of CSF leak),Coma or persistent vegetative state not caused by TBI,patients with autonomic dysfunction and unstable Long bone fracture, associated injuries
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Coma recovery scale revised
(CRS-R) |
1 st day, end of 1st week and end of 2nd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensory stimulation Assessment Measure (SSAM) |
1 st day, end of 1st week and end of 2nd week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After briefing about demographic variables,
| Patients will be screened depending upon the inclusion criteria. An informed consent to participate in the study will 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. 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 . Experimental group will be administered with the newly developed therapy –“Meaningful multimodal coma stimulation technique†A detailed history about likes and dislikes of the patients will be taken. 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 meaningfulness and feasibility eg) Patient will be made to sit in a wheelchair, will be made to feel the texture and shape of orange (tactile) will be made to look at the orange(visual stimuli) will be made to peel the orange and smell it (olfactory stimuli) dipping a cotton ear-bud in orange and pressing it on tongue patient will be made to appreciate its taste (gustatory stimuli). Various functional tasks that includes all the stimuli or a combination of them will be used for the patient.Duration of each stimuli will be 5-15 minutes depending upon patients response. Duration of treatment will be same for both the groups – 45 minutes thrice a day for 2 weeks .CRS-R and SSAM scores will be taken at the time of admission (48 hours after traumatic brain injury in case of medically managed patients and 48 hours after operation in case of surgically managed patients), end of 1st week and end of 2nd week. | |