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CTRI Number  CTRI/2024/02/063060 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To identify the benefits and harms of using hyperbaric oxygen therapy in treatment of stroke patients. 
Scientific Title of Study   Role of Hyperbaric Oxygen Therapy in Rehabilitation of Stroke Patients: A Randomized Controlled Pilot Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramakant Yadav 
Designation  Professor 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai,Etawah 
Address  Room No-G1, OPD Block, Department of Neurology, UPUMS Saifai

Etawah
UTTAR PRADESH
206130
India 
Phone  7987231371  
Fax    
Email  rkyadav_2003@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramakant Yadav 
Designation  Professor 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai,Etawah 
Address  Room No-G1, OPD Block, Department of Neurology, UPUMS Saifai

Etawah
UTTAR PRADESH
206130
India 
Phone  7987231371  
Fax    
Email  rkyadav_2003@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramakant Yadav 
Designation  Professor 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai,Etawah 
Address  Room No- G1, OPD Block, Department of Neurology, UPUMS Saifai

Etawah
UTTAR PRADESH
206130
India 
Phone  7987231371  
Fax    
Email  rkyadav_2003@yahoo.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences 
 
Primary Sponsor  
Name  Uttar pradesh university of medical sciences 
Address  Etawah, U.P, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramakant Yadav  Uttar pradesh university of medical sciences, SAIFAI  Room No: G1, OPD Block, Department of Neurology, UPUMS Saifai
Etawah
UTTAR PRADESH 
7987231371

rkyadav_2003@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Uttar Pradesh University of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C will receive conventional physiotherapy alone  Patients of group C will also spend equal time as group H in a hyperbaric chamber, but on 1 ATA air for proper blinding purposes. 
Intervention  Group H will receive Hyperbaric oxygen therapy along with conventional physiotherapy  The following HBOT protocol of 24 sessions will be practiced: 2.0 ATA 100% oxygen for 60 mins, 4 days a week for 6 consecutive weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  History of either hemorrhagic or ischemic stroke within 3- 6 months.
Hemodynamically stable patients. 
 
ExclusionCriteria 
Details  1.Patient Refusal.
2.Recurrent stroke
3.Untreated pneumothorax
4.Previous history of thoracic surgery, vascular surgery, angioplasty,
5.History of ear surgery, inner ear disease
6.Chronic sinusitis, major ear drum trauma
7.Upper respiratory tract infection,
8.Congestive cardiac failure, unstable angina
9.Convulsions
10.Claustrophobia
11.Metal implant
12.Uncontrolled Diabetes
13.Uncontrolled Hypertension 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
All patients will be assessed for neurological functions such as motor function, and cognitive function by using NIHSS and MMSE.   before the start of therapy as a baseline evaluation (T1), after completion of 24 sessions of HBOT (T2)  
 
Secondary Outcome  
Outcome  TimePoints 
All patients will be assessed for quality of life by using short-form health survey with 36 questionnaires.  a baseline evaluation (T1), after completion of 24 sessions of HBOT (T2) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/02/2024 
Date of Study Completion (India) 20/10/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Stroke is a leading cause of death and long-term serious disability [1]. 80% of all patients with stroke experience hemiparesis of contralateral limbs. Spontaneous recovery is less likely to occur six months following a stroke [2]. Muscle weakness and impaired motor control due to hemiparesis lead to functional impairment and poor quality of life.

Hyperbaric Oxygen Therapy (HBOT) is a treatment in which a patient breathes 100 % oxygen while inside a treatment chamber at a pressure higher than the sea level pressure. Scientific evidence strongly suggests its use as a main treatment modality in arterial gas embolism, decompression sickness, and severe carbon monoxide poisoning [3].

HBOT was also administered in cases of acute ischemic stroke and poststroke patients and the emerging literature on the subject reported that some patients may benefit from HBOT and others may not [4]. Significant improvement has been seen in motor and all cognitive domains after administering HBOT to a stroke patient even in the chronic stage. HBOT-induced neuroplasticity is mediated by neurogenesis of endogenous neural stem cells, stimulating cell proliferation, improved maturation and myelination of injured neural fibers, regeneration of axonal white matter, and stimulation of axonal growth, thus increasing the ability of neurons to function and communicate with each other [5]. This pilot study aims to establish more information about hyperbaric oxygen therapy for this group of patients, so that a valid treatment protocol can be set to initiate the best possible comparative study.This randomized, double-blind, Pilot study will be conducted on 30 patients after approval by the institutional ethical committee. All patients will be randomly allocated into two groups of 15 each. A computer-generated random number table will do randomization.

Group H: 15 patients will receive Hyperbaric oxygen therapy along with conventional physiotherapy

Group C: 15 patients will receive conventional physiotherapy alone

All patients will be taught about hyperbaric oxygen therapy and their related risks if any. All patients will also be taught about the measurement variables and their outcomes. After getting written informed consent, all patients will be invited for baseline evaluations of demographic characteristics such as age, gender, BMI, vitals (pulse rate, systolic blood pressure, diastolic blood pressure, and SPO2), the onset of stroke (duration), neurological deficit, affected side and associated comorbidities like Diabetes mellites, hypertension, thyroid dysfunction, etc. 15 patients of group H, who survived a stroke episode with hemiparesis 3 to 6 months before inclusion, will receive 24 sessions of hyperbaric oxygen therapy along with conventional physiotherapy.

The following HBOT protocol of 24 sessions will be practiced:

2.0 ATA 100% oxygen for 60 mins, 4 days a week for 6 consecutive weeks.

Patients of group C will also spend equal time as group H in a hyperbaric chamber, but on 1 ATA air for proper blinding purposes. Both patients and neurologists will be unaware of group allocation and treatment advised.

All patients will be assessed for neurological functions such as motor function, cognitive function, and quality of life two times, before the start of therapy as a baseline evaluation (T1), after completion of 24 sessions of HBOT (T2) by using NIHSS, MMSE and short-form health survey with 36 questionnaires respectively by a neurologist.

All patients of group H will undergo an ENT checkup before therapy to rule out eustachian tube dysfunction and any middle ear pathology. All patients of Group H will undergo an ophthalmology checkup after each week during the therapy phase. All patients will be allowed to take treatment for their comorbid conditions like hypertension, dyslipidemia, hypothyroidism, and cardiac disease under the supervision of a neurologist. All other treatment measures will be allowed during the study period.

The outcome variables will be NIHSS, MMSE, and QOL.

 
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