To determine the effects of virtual reality based training in rehabilitation of upper limb dysfunctions of stroke patients
Design
Quasi experimental design, no randomization with no blinding, only a single group of intervention
Settings and conduct
Quasi experimental Study was done at Pakistan railway General Hospital in 6 months duration (1st Jul, 2016-1st Jan, 2017)
Participants/Inclusion and exclusion criteria
Patients with any type of stroke (hemorrhagic or ischemic), age between 30 -70 years, with at least one score on box and block test were included, while stroke patients with cognitive impairments, upper limb contractures and inability to sit independently were excluded from the study.
Intervention groups
Patients were provided with traditional upper limb training protocol including passive Range of Motion (ROM), active ROM exercises, Electric Muscle Stimulation (EMS) for 10 minutes, therapeutic stretching, positional stretch and weight bearing for 15-20 minutes along with Virtual Reality Training through X-Box 360.
Main outcome variables
Fugl-Meyer Assessment (FMA-UE),
Box and Block Test (BBT), and
Wolf Motor Assessment Scale (WMFT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191107045358N2
Registration date:2021-04-14, 1400/01/25
Registration timing:retrospective
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Muhammad Ashar Rafi
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441753
Email address
ashar.dpt@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-01, 1395/04/11
Expected recruitment end date
2016-12-01, 1395/09/11
Actual recruitment start date
2016-07-01, 1395/04/11
Actual recruitment end date
2016-12-01, 1395/09/11
Trial completion date
2016-12-01, 1395/09/11
Scientific title
Virtual Reality Training Improves Upper Limb Functions In stroke Survivors
Public title
Effect of X-Box gaming on upper limb dysfunctions of stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with any type of stroke (hemorrhagic or ischemic)
Age between 30 -70 years
At least one score on box and block test
Exclusion criteria:
Stroke patients with cognitive impairments
Upper limb contractures
Inability to sit independently
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
It was a Qausi Experimental study having only one group of intervention
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee, Riphah college of Rehabilitation Sciences
Street address
Pothohar Campus, main Peshawar road. Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2016-12-29, 1395/10/09
Ethics committee reference number
RIPHAH/RCRS/REC/Letter-168
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I62.9
ICD-10 code description
Nontraumatic intracranial hemorrhage, unspecified
2
Description of health condition studied
Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Gross motor function
Timepoint
Before Intervention and 6th week after intervention
Method of measurement
Fugl-Meyer Assessment (FMA-UE) Score
2
Description
Gross manual dexterity
Timepoint
Before Intervention and 6th week after intervention
Method of measurement
Box and Block Test
3
Description
Functional capacities of upper limb
Timepoint
Before Intervention and 6th week after intervention
Method of measurement
Wolf Motor Assessment Scale (WMFT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Railways General Hospital
Full name of responsible person
Dr. Arshad Nawaz Malik
Street address
Pakistan Railways General Hospital, Railway workshop road. Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 5481826
Email
ashar.dpt@outlook.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. Arshad Nawaz Malik
Street address
Railway workshop road. Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 5481826
Email
ashar_dpt.ahs@stmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Muhammad Ashar Rafi
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
House # 138-A, Street # 20, Gulzar e Quaid.
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 5971801
Email
ashar.dpt@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Muhammad Ashar Rafi
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Dar-ul-shifa Campus, Street # 03, Pitrus Bukhari Road. H-8/1. Islamabad.
City
Islamabad
Province
Federal
Postal code
46000
Phone
+92 51 8441753
Fax
Email
ashar.dpt@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Muhammad Ashar Rafi
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
House # 138-A, Street # 20, Gulzar e Quaid.
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 5971801
Email
ashar.dpt@outlook.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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Its not decided yet that will we share the IPD data or not
When the data will become available and for how long
After Publication and forever
To whom data/document is available
For general public and researchers
Under which criteria data/document could be used
Data will be published in one of the authentic journal or any data base. On request data can be shared with other researchers after reviewing their applications
From where data/document is obtainable
Data will be available through the following email address:
ashar.dpt@outlook.com
What processes are involved for a request to access data/document
Applicant can send an email to request data, after justification He/ She may get data within 3-4 days.