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EFFECTS OF VIRTUAL REHABILITATION ON UPPER EXTREMITY MOTOR RECOVERY IN PATIENTS WITH SUBACUTE STROKE

Protocol summary

Study aim
1. To investigate the effects of Microsoft Xbox Kinect-based Virtual Reality game training on the upper extremity motor rehabilitation of sub-acute post stroke survivors
Design
Single Blind, Randomized Controlled Clinical Trial
Settings and conduct
Trial will be conducted at Re Active Rehabilitation Center of The University of Faisalabad. The Trial is Single Blinded, Participants are blinded through Lottery Method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke, Stroke onset > 2 weeks and < 6 months • First-ever ischemic or hemorrhagic stroke confirmed by MRI or CT • Patients > age 25 • Unilateral upper extremity weakness, • Patients who could perform the reaching activity with their hemiparetic arm. • Both genders will be included • Voluntary shoulder, elbow and wrist movement which is able to perform In-game commands. Exclusion Criteria: • Patients with co-morbidities or neurodegenerative diseases, • Patients who are unable to follow verbal commands due to cognitive impairment or aphasia • Patients who are unable to participate Kinect-based VR due to any reason (e.g., visual impairment, hemi spatial neglect, apraxia) • History of seizures/fits, • Psychological illness,
Intervention groups
Group A: In this group patients will be treated with routine physiotherapy combined with virtual rehabilitation. Xbox Kinect will used for training. The exercise program consists of stretching, strengthening and isometric exercises. Virtual rehabilitation consists of 30 minutes session 5 days per week for 4 weeks Group B: In this group patients will be treated with routine physiotherapy program. Routine physiotherapy will be performed 30 minutes 10 repetitions, twice a day 5 days per week for 4 weeks.
Main outcome variables
Fugl-Meyer Assessment Brunnstrom Recovery Stages Modified Ashworth Scale The Motricity Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210507051203N1
Registration date: 2021-07-05, 1400/04/14
Registration timing: registered_while_recruiting

Last update: 2021-07-05, 1400/04/14
Update count: 0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Osama Saeed
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
osama.saeed@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-09-10, 1400/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF VIRTUAL REHABILITATION ON UPPER EXTREMITY MOTOR RECOVERY IN PATIENTS WITH SUBACUTE STROKE
Public title
EFFECTS OF VIRTUAL REHABILITATION ON UPPER EXTREMITY MOTOR RECOVERY IN PATIENTS WITH SUBACUTE STROKE
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Ischemic or hemorrhagic stroke • Stroke onset with less than 2 weeks and more than 6 months • First-ever ischemic or hemorrhagic stroke confirmed by MRI or CT • Patients with more than 25 years and less than 65 years Old • Unilateral upper extremity weakness, • Patients who could perform the reaching activity with their hemiparetic arm. • Both genders will be included • Voluntary shoulder, elbow and wrist movement which is able to perform In-game commands. • Subjects willing to participate in the study.
Exclusion criteria:
• Patients with co-morbidities or neurodegenerative diseases, • Uncontrolled medical condition (e.g., active infection, pulmonary embolism, unstable angina), • Patients who are unable to follow verbal commands due to cognitive impairment or aphasia • Patients who are unable to participate Kinect-based VR due to any reason (e.g., visual impairment, hemi spatial neglect, apraxia) • History of seizures/fits, • Psychological illness, • Bony deformities • Prior history of drugs that could alter balance will be excluded from the study
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be generated by Online Randomizer
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will not have any information about the treatment given in both groups
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
UIPT Ethical Review Committee
Street address
Defence Road, Near Bhuptian Chowk
City
Lahore
Postal code
36000
Approval date
2021-02-10, 1399/11/22
Ethics committee reference number
UIPT/201/ERC/2018

Health conditions studied

1

Description of health condition studied
Subacute Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified

Primary outcomes

1

Description
Fugl Meyer Assessment
Timepoint
Before Intervention, 2 Weeks and 4 Weeks
Method of measurement
226 points multi-item questionnaire used for the evaluation of recovery from stroke

Secondary outcomes

1

Description
• Brunnstrom Recovery Stages
Timepoint
Baseline, 2 Weeks and after 4 Weeks
Method of measurement
Brunnstrom recovery stages or BRS is 6-stage evaluation tool indicating the recovery after stroke

2

Description
Modified Ashworth Scale
Timepoint
Baseline, 2 Weeks and after 4 Weeks
Method of measurement
It is 6 points scale ranging from 0-4 and lower reading indicates the normal tone of muscle and higher score means more resistance to passive movement or spasticity

Intervention groups

1

Description
Intervention Group 1: In this group patients will be treated with routine physiotherapy combined with virtual rehabilitation. The exercise program consists of stretching, strengthening and isometric exercises. Virtual rehabilitation consists of 30 minutes session 5 days per week for 4 weeks
Category
Rehabilitation

2

Description
Intervention Group 2 In this group patients will be treated with routine physiotherapy program. Routine physiotherapy will be performed 30 minutes 10 repetitions, twice a day 5 days per week for 4 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Re Active Rehabilitation Center
Full name of responsible person
Muhammad Mohsin Hussain
Street address
West Canal Road, Faisal Town Faisalabad
City
Faisalabad
Postal code
36000
Phone
+92 41 8750971
Email
m.mohsinhussain@tuf.edu.pk
Web page address
https://tuf.edu.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Madina Teaching Hospital
Full name of responsible person
Muhammad Mohsin Hussain
Street address
West Canal Road, Faisal Town
City
Faisalabad
Postal code
38000
Phone
+92 41 8750971
Email
m.mohsinhussain@tufedu.pk
Web page address
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NA
Proportion provided by this source
1
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
The University of Faisalabad
Full name of responsible person
Osama Saeed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
West Canal Road, Faisal Town
City
Faisalabad
Province
Punjab
Postal code
36000
Phone
+92 41 8750971
Email
osama.saeed@tuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Madina Teaching Hospital
Full name of responsible person
Muhammad Mohsin Hussain
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
West Canal Road, Faisal Town
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8750971
Email
m.mohsinhussain@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Madina Teaching Hospital
Full name of responsible person
Osama Saeed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
West Canal Road, Faisal Town
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8750971
Email
osama.saeed@tuf.edu.pk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
It will depend upon the journal where it will be published
When the data will become available and for how long
It will depend upon the journal where it will be published
To whom data/document is available
Researchers , Scholars, Physiotherapist
Under which criteria data/document could be used
None
From where data/document is obtainable
Direct Contact with Responsible
What processes are involved for a request to access data/document
Access as per policy
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