| 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
|
|
|
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
|
|
|
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. |