To check the effects of virtual rehabilitation versus therapeutic exercises in improving the balance of the lower limb of post-stroke patients.
Design
Randomized Control Trial
Settings and conduct
Physiotherapy Department of Abdullah Hospital Lalamusa
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Age: 35 – 55 years.
• Potential participants with 3 months post-stroke lower limb movement difficulties.
• Ability to stand up with or without assistive devices
• Patients with stable vital signs
Exclusion Criteria:
• Subjects with severe hypertension.
• Lower limb amputation.
• Patients with a history of Deep venous thrombosis or Pulmonary embolism.
• Auditory or visual dysfunction.
• If the patient has severe receptive or expressive aphasia that affects the ability to communicate with or give consent.
• Significant cognitive impairment such as the ability to follow two-level commands.
Intervention groups
Experimental group played video games using X-box and Kinect connected to the laptop. This group performed training for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The repetitions will increase according to the performance of the patient. Games were started from the basic level and the level was increased according to the patient’s performance. The training was done under the supervision of a trained physiotherapist to avoid any hazards.
Main outcome variables
Balance
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20201021049094N2
Registration date:2022-12-10, 1401/09/19
Registration timing:retrospective
Last update:2022-12-10, 1401/09/19
Update count:0
Registration date
2022-12-10, 1401/09/19
Registrant information
Name
Raheela Kousar
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 53 3589155
Email address
raheelasaleem10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-19, 1401/05/28
Expected recruitment end date
2022-10-26, 1401/08/04
Actual recruitment start date
2022-08-19, 1401/05/28
Actual recruitment end date
2022-10-25, 1401/08/03
Trial completion date
2022-12-06, 1401/09/15
Scientific title
Effectiveness of virtual rehabilitation versus therapeutic exercises in the balance training of lower limb among post-stroke patients
Public title
Effectiveness of virtual rehabilitation versus therapeutic exercises in the balance training of lower limb among post-stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 35 – 55 years.
Potential participants with 3 months post-stroke lower limb movement difficulties.
Ability to stand up with or without assistive devices and patients with stable vital signs.
Exclusion criteria:
Exclusion Criteria: Subjects with severe hypertension.
Patients with a history of Deep venous thrombosis or Pulmonary embolism
Lower limb amputation
Auditory or visual dysfunction
If the patient has severe receptive or expressive aphasia that affects the ability to communicate with or give consent
Significant cognitive impairment such as the ability to follow two-level commands
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by lottery method. Allocation concealment through a sealed envelope. In a bowl, we put closed slips of groups A and B. Participants fulfilling inclusion criteria randomly picked up groups and then allocated them through a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient was not aware of the group treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Lahore, Gujrat Campus
Street address
University of Lahore, Gujrat campus near chenab river
City
Gujrat
Postal code
50700
Approval date
2022-08-18, 1401/05/27
Ethics committee reference number
REC/GRT/22/AHS-92
Health conditions studied
1
Description of health condition studied
Stroke: Stroke is a disease of the central nervous system produced by obstruction of the cerebral blood flow due to the occlusion (ischemic stroke) or rupture (hemorrhagic stroke) of a cerebral blood vessel. Afferent and efferent neural pathways are affected, and motor, sensitive and cognitive capabilities become impaired as a result of brain cortex injury. Motor and cognitive damage reduce their functional potential and independence.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
Before intervention, Mid intervention and After intervention
Method of measurement
Berg Balance Scale
Secondary outcomes
1
Description
Range of Motion
Timepoint
Before intervention, Mid intervention and after intervention
Method of measurement
Through Goniometer
Intervention groups
1
Description
Intervention group: They group played video games using X-box and Kinect connected to the laptop. This group performed training for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The repetitions will increase according to the performance of the patient. Games were started from the basic level and the level was increased according to the patient’s performance. The training was done under the supervision of a trained physiotherapist to avoid any hazards.
Category
Rehabilitation
2
Description
Control group: They performed balance exercises such as the tandem walk, heel stand, forward striding, side step, single leg stand, and double leg stand for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The exercises were done under the supervision of the Physiotherapist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Abdullah Hospital Lalamusa
Full name of responsible person
Hana Pervaiz
Street address
Main Gt road Lalamusa near railway station.
City
Lalamusa
Postal code
50200
Phone
+92 304 0907209
Email
hanapervaiz7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Hana Pervaiz
Street address
Mohala kaira ward no.1 house no.B-115, Lalamusa Pakistan
City
Lalamusa
Postal code
50200
Phone
+92 304 0907209
Email
hanapervaiz7@gmail.com
Web page address
https://grt.uol.edu.pk/
Grant name
The University of Lahore
Grant code / Reference number
REG/GRT/22/AHS-92
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Hana Pervaiz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mohala kaira ward no.1 house no.B-115, Lalamusa Pakistan
City
lalamusa
Province
punjab
Postal code
50200
Phone
+92 304 0907209
Email
hanapervaiz7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of lahore
Full name of responsible person
hana pervaiz
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mohala kaira ward no.1 house no.B-115, Lalamusa Pakistan
City
lalamusa
Province
punjab
Postal code
50200
Phone
+92 304 0907209
Email
hanapervaiz7@gmail.com
Web page address
https://grt.uol.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
the university of lahore
Full name of responsible person
hana pervaiz
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mohala kaira ward no.1 house no.B-115, Lalamusa Pakistan
City
lalamusa
Province
punjab
Postal code
50200
Phone
+92 304 0907209
Email
hanapervaiz7@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available