The effect of Nintendo Wii on ankle spasticity in patients with stroke
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 30 patients.Blocking method was used for randomization.
Settings and conduct
Patients who meet the inclusion criteria are invited to be present at the Neuron Neurology Clinic located in Isfahan.
Then the patient enters one of the test groups according to the block table randomly entered by one uninformed person.
Participants/Inclusion and exclusion criteria
From patients with stroke who have ankle spasticity and able to stand without an aid for at least 30 seconds is invited to participate in the study.
Intervention groups
Individuals in the control and intervention groups receive treatment with valid scientific evidence to reduce spasticity.
In addition to receiving routine treatment, the intervention group is treated with 30 minutes of Nintendo Wii games, 3 times a week for 12 sessions.
Main outcome variables
1. H- reflex Latency
2. H maximum /M maximum Ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200101045970N3
Registration date:2020-10-03, 1399/07/12
Registration timing:registered_while_recruiting
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Ehsan Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
eghasemi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-09, 1399/06/19
Expected recruitment end date
2021-03-09, 1399/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nintendo Wii on ankle spasticity in stroke patients: a randomized clinical trial
Public title
The Impact of the Nintendo Wii on Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 85 years
History of the first unilateral stroke by a neurologist through CT scan or MRI findings.
Spasticity in the ankle joint according to the Modified Modified Ashworth Scale with MMAS≥ 1
Existence of appropriate cognitive status based on Persian version of Mini mental Status Exam (MMSE> 24
Ability to maintain a standing position without the use of assistive devices for at least 30 seconds.
Exclusion criteria:
History of myocardial infarction or high-risk heart disease
Existence of other neurological disorders such as neuropathy, epilepsy, seizures, etc.
Existence of diabetes as a metabolic disorder
Use of botulinum or other oral antispasmodics
Participate in other physiotherapy treatment interventions
Contracture and rigidity in plantar flexor muscles
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the small sample size and consultation with a statistician, it was decided to use the random blocking method.
Using a statistical software of 15 blocks that consisted of two members used for allocation. An uninformed person enters the persons into this study based on these blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients were unaware of the groups.Also, the person conducting the assessments was unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Medical University
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-09-06, 1399/06/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.309
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G90-G99
ICD-10 code description
سایر بیماریهای سیستم اعصاب
Primary outcomes
1
Description
H Reflex Latency
Timepoint
Before the intervention and after the intervention
Method of measurement
Using a neural activity recorder.
2
Description
H max/M max Ratio
Timepoint
Before and after the intervention
Method of measurement
Use of nerve electrical activity recorder
Secondary outcomes
1
Description
Muscle Tone
Timepoint
Before and after the intervention
Method of measurement
Modified Modified Ashworth Scale
2
Description
Functional Mobility
Timepoint
Before and After Intervention
Method of measurement
Timed Up and Go test
3
Description
Quality of Life
Timepoint
Before and After Intervention
Method of measurement
SF36 Questionnaire
Intervention groups
1
Description
Intervention group: In addition to receiving routine treatment, the intervention group is treated with 30 minutes of N-Wii game three times a week for 12 sessions in the same session and after a 5-minute break.All games are played standing on the balance screen of the device without the use of assistive devices.
Category
Rehabilitation
2
Description
Control group: Individuals in the control and intervention groups receive treatment with valid scientific evidence to reduce spasticity. Positioning the limbs in the form of antispasmodic patterns, range of motion exercises and functional stretching for 30 minutes, there will be three sessions per week for 12 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Neuron Neurology Center
Full name of responsible person
Narges Yousefi
Street address
Mohtasham Kashani St., corner of the dead end 34
City
Isfahan
Province
Isfehan
Postal code
..........
Phone
+98 31 3625 8575
Email
yousefi.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical 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
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Fax
+98 31 3668 7270
Email
ehsan_kowsar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
ِAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
HezarJrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Fax
+98 31 3668 7270
Email
ehsan_kowsar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Fax
+98 31 3668 7270
Email
ehsan_kowsar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We are excused from publishing information due to ethical and misuse of information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not 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
The study protocol has been published as an article in the Journal of Research in Rehabilitation Sciences of Isfahan.
The consent form is also available in the proposal.
Clinical results will be published after the end of the study.
When the data will become available and for how long
Study protocol and consent already available.
Clinical results will be published in the summer of 1400.
To whom data/document is available
Researchers working in scientific institutes and patients.
Under which criteria data/document could be used
In order to raise information and familiarity with the methods used in the study.
From where data/document is obtainable
To receive the protocol, they can refer to the Journal of Research in Rehabilitation Sciences.They can also contact Dr. Ehsan Ghasemi to receive a proposal.
What processes are involved for a request to access data/document