Investigating the effect of specific therapeutic exercise using virtual reality system on the lower limb's function of stroke patients
Design
Clinical trial with control group, with parallel groups, simple randomization with coin toss method, 60 patients
Settings and conduct
The study takes place at Rofeydeh Rehabilitation Hospital. People suffering from stroke admitted or referred to Rofeydeh Hospital are included in the study, which are divided into two control and intervention groups using a simple sampling method according to the entry and exit criteria and by random grouping .They will receive 10 treatment sessions according to their group.
The control group will perform therapeutic exercises without the virtual reality system and the intervention group will perform the same exercises using the virtual reality system. Tests related to variables will be taken from people once before the beginning of the sessions and once after 10 sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• At least 6 months and at most 36 months have passed since the stroke.
• Spasticity should not be excessive (score of 3 and 4 in the MAS questionnaire).
• The patient should be able to stand independently or with assistive devices
Exclusion criteria:
• Use of botulinum toxin or surgery last 6 months
• Vision or Vestibular disorders
• presence of orthopedic disorders that prevent the desired movements
• Apraxia disorder
Intervention groups
control group : 10 conventional physiotherapy sessions including electrotherapy, general therapeutic exercise and specific therapeutic exercise. intervention group: In addition to receiving conventional physiotherapy will perform specific therapeutic exercise using virtual reality for 10 sessions.
Main outcome variables
1. Berg Balance Scale
2. Lower limb function (Timed up and go Test)
3. Ability to perform daily activities (Modified Barthel Scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241016063383N1
Registration date:2024-10-19, 1403/07/28
Registration timing:prospective
Last update:2024-10-19, 1403/07/28
Update count:0
Registration date
2024-10-19, 1403/07/28
Registrant information
Name
Nika Zarrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 4272
Email address
nikazarrabi97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-30, 1403/09/10
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of specific exercise training using virtual reality on lower extremity function of stroke patients
Public title
Effect of therapeutic exercise using virtual reality on the performance of stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has suffered a stroke for the first time and has been confirmed by a neurologist.
At least 6 months and at most 36 months have passed since the stroke
Spasticity should not be excessive (with a score of 3 and 4 in the MAS questionnaire)
The patient should be in a favorable condition in terms of understanding and cognition and should be able to communicate.
The patient should be able to stand independently or with assistive devices (cane, walker)
Exclusion criteria:
The patient is not in a stable medical condition (heart problems, blood pressure, breathing).
The patient has a history of other neurological problems or psychological problems
Use of botulinum toxin in the past 6 months
Surgery in the last 6 months
Apraxia disorder
The presence of orthopedic and skeletal disorders in a person that prevents the desired movements.
Vestibular disorders
Visual disorders
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The grouping will be done by a simple random method of coin toss and the patients will be randomly divided into two control and intervention groups by tap or line method and will be treated in each group according to the specific method of that group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and rehabilitation sciences
Street address
No.17, East Biglarpor, Jahantab Ave, East Akhlaghi Ave, Kaveh Blvd, Dolat Ave.
City
Tehran
Province
Tehran
Postal code
1939945511
Approval date
2024-09-23, 1403/07/02
Ethics committee reference number
IR.USWR.REC.1403.132
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I69.4
ICD-10 code description
Sequelae of stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Changes in the individual's static and dynamic balance score based on the Berg Balance Scale short test.
Timepoint
Once before the intervention and once after 10 treatment sessions
Method of measurement
Short Berg Balance Scale
2
Description
Functional changes of the lower limb using the Timed up and go test
Timepoint
Once before the intervention and once after 10 treatment sessions
Method of measurement
Timed up and Go test
3
Description
Determining the ability to perform daily activities using the modified Barthel scale
Timepoint
Once before the intervention and once after 10 treatment sessions
Method of measurement
modified Barthel Index of ADL
Secondary outcomes
empty
Intervention groups
1
Description
The tool used in this study is the Sana virtual reality system, which provides the ability to perform exercises in different fields of rehabilitation. The system used, has a Kinect camera (it is a motion detection system based on photography) that records motion data from the patient's limb movements and then analyzes the motion data by a pre-processing unit. It also uses a 32-inch monitor that has been trained to show the virtual space to the patient and provide appropriate audio and visual feedback in each exercise. Intervention group: The participants will be treated 3 days a week and every other day for 10 sessions. In the specific therapeutic exercise, each exercise will be done in three sets of ten. In addition to receiving electrotherapy and general therapeutic exercise, the intervention group will perform specific therapeutic exercise using virtual reality, 10 sessions of each exercise in three sets of ten. Functional tests related to the study once before the treatment and once after 10 treatment sessions will be taken from people and the results will be compared. Specific therapeutic exercises include: trunk control exercises, weight shifting, bearing weight on the non-affected limb and bringing the knee of the affected limb to the desired goal, bearing weight on the affected limb and bringing the leg of the other limb to the desired goal and bringing the hand and foot of the affected side alternately to the intended target.
Category
Rehabilitation
2
Description
Control group: The participants will be treated 3 days a week and for 10 sessions every other day. The control group will receive 10 conventional physiotherapy sessions including electrotherapy, general therapeutic exercise and specific therapeutic exercise. In the specific therapeutic exercise, each exercise will be done three sets of ten .Specific therapeutic exercises include: trunk control exercises, weight shifting, bearing weight on the non-affected limb and bringing the knee of the affected limb to the desired goal, bearing weight on the affected limb and bringing the leg of the other limb to the desired goal and bringing the hand and foot of the affected side alternately to the intended target.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofeyde rehabilitation hospital
Full name of responsible person
Nika zarrabi
Street address
No. 17,Biglarpur East, Jahantab, East akhlaghi, Kaveh Blvd, Dolat Street
City
Tehran
Province
Tehran
Postal code
1939945511
Phone
+98 21 2276 4272
Fax
+98 919 426 7536
Email
nikazarrabi97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nika zarrabi
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
nikazarrabi97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Nika Zarrabi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.17 ,East Biglarpour, Jahantab, East Akhlaghi, Kaveh blvd, Dolat street, Tehran
City
Tehran
Province
Tehran
Postal code
1939945511
Phone
+98 21 2276 4272
Fax
Email
nikazarrabi97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nika Zarrabi
Position
master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.17 ,East Biglarpour, Jahantab, East Akhlaghi, Kaveh blvd, Dolat street, Tehran
City
Tehran
Province
Tehran
Postal code
1939945511
Phone
+98 21 2276 4272
Fax
Email
nikazarrabi97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nika Zarrabi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.17 ,East Biglarpour, Jahantab, East Akhlaghi, Kaveh blvd, Dolat street, Tehran
City
Tehran
Province
Tehran
Postal code
1939945511
Phone
+98 21 2276 4272
Fax
Email
nikazarrabi97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Data on key variables and their statistical results can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers in all levels and disciplines
Under which criteria data/document could be used
The requester of the documents will be able to use the data only by mentioning the source and the name of the researcher.
From where data/document is obtainable
To access the information, send a message to this email: nikazarrabi97@gmail.com
What processes are involved for a request to access data/document
The applicant should express his/her request by sending an email and she will be answered within a week.