| 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
|
|
|
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
|
|
|
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
|
|
|
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] |