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CTRI Number  CTRI/2024/11/076823 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Virtual Reality vs Conventional Therapy: A Pilot Study on Balance and Anxiety Reduction in Adult Stroke Patients. 
Scientific Title of Study   Comparing the efficacy of virtual reality and conventional therapy on balance and anxiety reduction in adult stroke patients-A 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  Komal Sehgal 
Designation  Student 
Affiliation  Galgotias university 
Address  ROOM NO-E004 Galgotias University, Department of physiotherapy, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8595986693  
Fax    
Email  komalsehgal158@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chhavi kumar sharma 
Designation  Assistant Professor 
Affiliation  galgotiasuniversity 
Address  ROOM NO-B512, School of allied health sciences, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9410062820  
Fax    
Email  chhavisharma@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Chhavi kumar sharma 
Designation  Assistant Professor 
Affiliation  galgotias university 
Address  ROOM NO-E004 Galgotias University, Department of physiotherapy, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8595986693  
Fax    
Email  chhavisharma@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Research and Devlopment cell Galgotias university,ROOM NO-E004 Galgotias University, Department of physiotherapy, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, UP, India PIN: 203201 
 
Primary Sponsor  
Name  Galgotias University 
Address  Room no B512 department of physiotherapy school of alleid health sciences galgotias university Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Chhavi kumar sharma  School Of Allied Health Sciences Galgotias University  Room no E-004 School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH 
9410062830

chhavisharma@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F418||Other specified anxiety disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy for 4 weeks  For assessing anxiety in adult stroke patient for 4 week 
Intervention  Virtual reality for 4 weeks  Efficacy of virtual reality on balance in adult stroke patients for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults aged 18-80 years, with diagnosis of stroke with hemiparesis or
hemiplegia
Male and female both included
People able to walk
Adult pt. with stroke
Acute phase
Subacute phase
Chronic phase
 
 
ExclusionCriteria 
Details  Include visual disorders
Score less than 24 on MMSE
(moderate cognitive impairment)
Musculoskeletal disorder that hinder balance
Migraine and peripheral neuropathy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Balance, during intervention for 4 weeks.  By using Berg Balance Scale in 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Na  Na 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Brain strokes are a prevalent, severe, and incapacitating global health issue. Brain stroke is one of the primary causes of acquired adult impairment and the second or third most prevalent cause of death in the majority of countries. Since the majority of stroke patients will recover from their initial illness, the long-term effects on patients and their families typically have the largest impact on health. Over the following 20 years, there will likely be a rise in the prevalence of brain stroke- related morbidity. Even though there have been significant advancements in the medical treatment of stroke, the majority of post-brain stroke care will still depend on rehabilitative therapies in the absence of a generally available or efficient medical treatment. [1] Ischemic brain stroke, also known simply as ischemic stroke, occurs when a blood clot or other obstruction blocks blood flow to a part of the brain, resulting in a shortage of oxygen and nutrients. This interruption in blood supply leads to the death of brain cells in the affected area and can cause significant neurological impairment or disability. Ischemic strokes are categorized into two main types: thrombotic strokes, where a clot forms in one of the brain’s arteries, and embolic strokes, where a clot forms elsewhere in the body and travels to the brain. Prompt diagnosis and treatment are critical to minimize brain damage and improve outcomes for patients. [2]

Balance impairment after stroke refers to difficulties in maintaining postural stability and coordination due to the disruption of neural pathways that control balance. Following a stroke, patients often experience deficits in sensory processing, motor control, and proprioception, all of which are crucial for maintaining balance and preventing falls. This impairment can significantly affect an individual’s ability to perform daily activities and increase the risk of falls, which can further contribute to functional decline and reduced quality of life.[3] New approaches to improving rehabilitation results are promising, thanks to recent developments in psychological testing and technology. This study investigates the potential benefits of combining psychological evaluation and virtual reality technology to enhance post-stroke balance therapy. [4]

 

Virtual reality technology, which include augmented reality (AR) and virtual reality (VR), have shown great promise in rehabilitation environments. These technologies provide dynamic, immersive environments that may be tailored to target certain motor impairments and balance deficits. [5] Conventional therapy for balance impairment following a stroke typically includes physical therapy and rehabilitation exercises designed to improve postural control, strength, and coordination. These therapies often involve balance training exercises, gait training, and functional tasks aimed at enhancing the patient’s ability to maintain stability and prevent falls. The approach may also include techniques such as proprioceptive training and cognitive strategies to address the complex nature of balance disturbances.[6]

Research has indicated that virtual reality (VR) - based therapies can enhance gait and balance by offering patients stimulating and adaptable training environments that push them beyond what traditional therapy can. VR apps, for example, can replicate a variety of situations that call for patients to adjust and react, encouraging neuroplasticity and functional recovery. [7]

In addition to technology advancements, psychological evaluations are essential for rehabilitation since they address mental health, stress, and anxiety. Studies reveal that psychological factors have a major impact on rehabilitation outcomes; patients who are more motivated and have better emotional states tend to recover more quickly. Therapists can improve overall rehabilitation effectiveness and recovery by customizing interventions to address psychological barriers identified by each patient by incorporating psychological assessments.[8] Anxiety is a complex emotional state characterized by persistent feelings of worry, fear, or apprehension that can interfere with an individual’s daily functioning. It is often accompanied by physical symptoms such as increased heart rate, muscle tension, and restlessness. Anxiety disorders are a group of mental health conditions that include generalized anxiety disorder, panic disorder, social anxiety disorder, and specific phobias, each with its own distinct symptoms and triggers. The prevalence of anxiety disorders underscores their impact on mental health and highlights the need for effective management strategies.[8], [9]

 

A fresh approach to rehabilitation is presented via the combination of psychological assessment and virtual realignment technology. This study

explores the potential applications of this integrated approach to develop more individualized and successful stroke survivors’ rehabilitation regimens. The goal is to assess if using an integrated approach improves overall quality of life, increases patient engagement, and promotes better balance recovery. [9]

By combining the benefits of both modalities, VR and conventional physiotherapy may provide a more thorough approach to rehabilitation. While virtual reality therapy can improve engagement, motivation, and psychological well-being, traditional therapies offer the fundamental physical support required for recovery. Integrative approaches have demonstrated potential in enhancing psychological and physical outcomes, indicating that combining VR with standard treatments in a synergistic way may yield better benefits than using traditional methods alone. [10]

According to research, virtual reality (VR) can enhance balance by generating regulated and flexible environments that promote mobility and coordination without the limitations of a conventional therapeutic setting. Furthermore, it has been demonstrated that VR’s immersive quality improves psychological well-being by lowering the symptoms of anxiety and depression that stroke patients frequently face. VR integration into balance treatment regimens has the potential to improve psychological well-being in addition to physical balance, providing a dual-benefit strategy for stroke rehabilitation. [11]

 
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