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EFFECT OF VIRTUAL REALITY TRAINING AND ROUTINE PHYSICAL THERAPY ON BALANCE AND FUNCTIONAL INDEPENDENCE IN STROKE PATIENTS

Protocol summary

Study aim
This is an era of machine learning. There is need of immediate application of such machine learning in Health Care. Although the work has been done in virtual reality in performance labs, this study is one of few that is being conducted directly with patient involvement. The unique feature is incorporating functional and recreational activities in stroke patient’s rehabilitation. The positive outcomes of this study can be integrated with machine learning algorithms that will be a revolution in field of stroke and other neurological rehabilitation.
Design
Randomized Clinical Trial
Settings and conduct
Kanaan Physiotherapy & Spine clinic, Shadman, Lahore, Pakistan
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA • male and female between Age 41-60 years with Unilateral involvement of extremity and First exposure of stoke episode either hemorrhagic or ischemic in origin and stroke evident by reports of CT Scan or MRI EXCLUSION CRITERIA • Ischemic heart disease with unstable angina, History of seizers, Motor impairment such as neuropathy or Parkinson’s disease, Severe aphasia that can limit participation or feedback and Cognitive mental condition that can interfere with comprehension of commands
Intervention groups
Patients will be randomly allocated in two groups of 34 patients each i.e. Virtual Reality Group and Routine Physical Therapy Group by Coin Tossing method.
Main outcome variables
Any systematic disease, body mass index, status of speech inactivity, affected side of body and score of movements at shoulder, elbow, wrist, hip, knee and ankle joints against medical research council scale. Functional assessment of hand, Upper limb and lower limb, Balance assessment

General information

Reason for update
Acronym
VRTSP
IRCT registration information
IRCT registration number: IRCT20190715044216N1
Registration date: 2019-08-09, 1398/05/18
Registration timing: prospective

Last update: 2019-08-09, 1398/05/18
Update count: 0
Registration date
2019-08-09, 1398/05/18
Registrant information
Name
Naveed Anwar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
naveedanwar982@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2639-12-11, 2018/09/20
Expected recruitment end date
2640-12-22, 2019/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECT OF VIRTUAL REALITY TRAINING AND ROUTINE PHYSICAL THERAPY ON BALANCE AND FUNCTIONAL INDEPENDENCE IN STROKE PATIENTS
Public title
EFFECT OF VIRTUAL REALITY TRAINING AND ROUTINE PHYSICAL THERAPY ON BALANCE AND FUNCTIONAL INDEPENDENCE IN STROKE PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both genders i.e. male and female Age between 41-60 years Unilateral involvement of extremity First exposure of stoke episode either hemorrhagic or ischemic in origin and stroke evident by reports of CT Scan or MRI At least a score of 2 on medical research council scale Stable alert patient and able to follow the instructions of physical therapist
Exclusion criteria:
Ischemic heart disease with unstable angina History of seizers Motor impairment such as neuropathy or Parkinson’s disease Severe aphasia that can limit participation or feedback Cognitive mental condition that can interfere with comprehension of commands
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated in two groups of 34 patients each i.e. Virtual Reality Group and Routine Physical Therapy Group by Coin Tossing method. “Heads” is for Virtual Reality Group and “Tails” for Routine Physical Therapy Group
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be a single blinded study blinding one of personnel of trial architecture i.e. assessors. Clinicians and patients are difficult to blind due to very nature of treatment protocol and study design.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
institutional Review Board
Street address
1km, defence road, bhobattian chowk, Lahore
City
Lahore
Postal code
60000
Approval date
2639-12-11, 2018/09/20
Ethics committee reference number
IRB-UOL-FAHS/373-III/2018

Health conditions studied

1

Description of health condition studied
Cerebrovascular Accident (CVA) (Stroke)
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome

Primary outcomes

1

Description
Functional independence
Timepoint
before intervention, 12 week after intervention, 24 week post intervention
Method of measurement
Strength testing on 0-5 scale and through Stroke impact scale questionnaire

2

Description
Balance
Timepoint
before intervention, 12 week after intervention, 24 week post intervention
Method of measurement
Balance measurement through balance board and through Berg balance scale

3

Description
Hand function
Timepoint
before intervention, 12 week after intervention, 24 week post intervention
Method of measurement
wolf motor hand function test

Secondary outcomes

empty

Intervention groups

1

Description
Virtual Reality group: The Wii is a home video game console released by Nintendo on November 19, 2006. As a seventh-generation console, the Wii competed with Microsoft's Xbox 360 and Sony's PlayStation 3. Nintendo states that its console targets a broader demographic than that of the two others. This device is the most suitable one to be utilized in this trial due to its control on three dimensional measurement. Patients in this group will get daily 60 minutes session, 3 days a week for 12 weeks.
Category
Other

2

Description
Routine physical therapy group: These include proven methods such as sustained stretching program for hypo flexibility, strengthening program for extensiblity and balance training and coordination exercise to improve motor control and deficit. Also include motivational sessions over the time. Patient in this group will get 60 minutes session, 3 days a week for 12 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kanaan Physiotherapy & Spine clinic, Shadman, Lahore, Pakistan.
Full name of responsible person
Naveed Anwar
Street address
Kanaan Healthcare center, near governor house, lahore, Pakistan.
City
Lahore
Postal code
60000
Phone
+92 42 36282885
Email
naveedanwar982@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kanaan Physiotherapy & Spine clinic
Full name of responsible person
Khalid Yaseen
Street address
36, Street 4, Baagbanpura, Mughalpura, Lahore
City
Lahore
Postal code
60000
Phone
+92 42 36282885
Email
naveedanwar982@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University, Lahore, Pakistan
Full name of responsible person
Naveed Anwar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
524/E Shah Rukn e alam, Multan
City
Lahore
Province
Punjab
Postal code
60000
Phone
+92 42 36282885
Email
naveedanwar982@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Naveed Anwar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
85, B Canal Gardens, Lahore
City
Lahore
Province
Punjab
Postal code
60000
Phone
+92 42 36282885
Email
naveedanwar982@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Kehkshan Khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
524/E Shah Rukn e alam, Multan
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 42 36282885
Email
naveedanwar982@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Analysed data will be shared for publication purpose
When the data will become available and for how long
Data will be available in January 2020
To whom data/document is available
It will be shared with nominated person of registry
Under which criteria data/document could be used
It can be used in health related research
From where data/document is obtainable
Data can be obtained by researcher
What processes are involved for a request to access data/document
Email requests
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