Comparing the effect of competitive and non competitive adaptive volleyball in real play context based on non linear pedagogy on motor complexity and participation among chronic stroke patients
The effect of adaptive volleyball on motor complexity and participation in chronic stroke patients
Design
Clinical trial with control group and parallel group design; double blind; randomization through block randomization method; performed on 45 patients
Settings and conduct
Intervention place: Javad Movafaghian Rehabilitation Research Center.
Blindness:
Participants will not be aware of which intervention group they will be in.
The evaluator will not be aware of which intervention group the sample will be allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stroke patients with middle artery injury based on neurologist diagnosis; Six months have passed since the stroke; Ability of 10 meters walk without any assistive devices at least; Good cognitive function (MMSE≥23);
Ability to pass a light ball by hand from a distance of one meter from the net (1.5 meters) by throwing.
Non-inclusion criteria: having hemispatial neglect; having visual or hearing problems that not corrected with glasses or ear-trumpet; having other neurologic, orthopedic or rheumatologic problems that limited stance and gait; history of playing volleyball or any other sport professionally
Intervention groups
Intervention group 1: non competitive adaptive volleyball (an adaptive volleyball for stroke patients based on size and weight of the ball, height of the net, play ground, play time and etc...).
Intervention group 2: competitive adaptive volleyball (similar to intervention group 1 except scoring to determine the winner team).
Control group: routine occupational therapy; exercises such as ROM, Stretch, ADL and etc
Main outcome variables
Motor behavior; participation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190930044934N1
Registration date:2020-12-19, 1399/09/29
Registration timing:registered_while_recruiting
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Zahra Ghorbanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6667 6805
Email address
za.ghorbanipour@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-08, 1399/07/17
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of competitive and non competitive adaptive volleyball in real play context based on non linear pedagogy on motor complexity and participation among chronic stroke patients
Public title
The effect of adaptive volleyball on motor and participation in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stroke patients with middle artery injury based on neurologist diagnosis
Six months have passed since the stroke
Ability of 10 meters walk without any assistive devices at least
Good cognitive function (MMSE≥23 )
Having an interest in playing volleyball
Ability to pass a light ball by hand from a distance of one meter from the net ( 1.5 meters) by throwing
Exclusion criteria:
Having hemispatial neglect
Having visual or hearing problems that not corrected with glasses or ear-trumpet
Having other neurologic, orthopedic or rheumatologic problems that limited stance and gait
History of playing volleyball or any other sport professionally
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into three groups (non competitive adaptive volleyball (group1), competitive adaptive volleyball (group2) and control (group3)) based on age and affected side by Covariate - adaptive randomization method. In total we will have 12 blocks for 3 groups as for each group we will have 4 blocks (a for the age above 60, b for the age below 60, c for the right affected side and d for the left affected side) the samples are randomly placed in one of 3 groups through the software but whether they are in block a or b or c or d will be determined based on their age and affected side.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be aware of which intervention group they belong to because they will receive intervention at different times and they will be explained in advance that, for the accuracy of the research work, no rehabilitation interventions of other groups (Except for their own intervention) will be explained in any way.
The evaluator will not be aware of the sample group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Ssciences
Street address
Kodakyar closed alley; Daneshjoo blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.USWR.REC.1397.010
Health conditions studied
1
Description of health condition studied
Brain stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Motor Behaviour
Timepoint
Before intervention, 7 weeks after intervention, 14 weeks after intervention
Method of measurement
Force plate, Motion Analysis, Functional Reach, Timed Up And Go, Electromyography, 10meter Walk Test
2
Description
Participation
Timepoint
Before intervention, 7 weeks after intervention, 14 weeks after intervention
Method of measurement
COPM, Stroke Impact Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Non competitive adaptive volleyball (This intervention is a volleyball game tailored for stroke patients which is given adjustments in the size and weight of the ball, the height of the net, the playing field, the playing time, etc. This intervention is performed as 36 sessions 3 times a week and in each session, two teams of 2 people play together)
Category
Rehabilitation
2
Description
Intervention group 2: Competitive adaptive volleyball (This intervention is similar to the group 1 intervention, except that in this intervention there is competition between the teams and the winning team is determined)
Category
Rehabilitation
3
Description
Control group: Routine occupational therapy exercises such as Range of motion, Stretching, Strengthening , activity of daily living, etc. The timing was similar to the other intervention groups
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
SHohadaTajrish hospital
Full name of responsible person
Gholamreza Mohseni
Street address
Tajrish avenue
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Loghman hospital
Full name of responsible person
Omidvar Rezaee
Street address
Kargar avenue
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir-Masod Arab
Street address
Daneshjoo Blvd, Evin avenue
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
pr@uswr.ac.ir
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
Zahra Ghorbanpour
Position
PhD candidate of occupational therapy
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Evin avenue
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 6667 6805
Email
zghorbanpor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Ghorbanpour
Position
PhD candidate of occupational therapy
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Evin avenue
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 6667 6805
Email
zghorbanpor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Ghorbanpour
Position
PhD candidate of occupational therapy
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Evin Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 6667 6805
Email
zghorbanpor@yahoo.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
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
Information on the main and secondary outcomes
When the data will become available and for how long
starting 6 months after publication.
To whom data/document is available
Researchers who intend to conduct research in this field.
Under which criteria data/document could be used
Obtaining the written permission of the research group, mention the source of the information
From where data/document is obtainable
Zahra Ghorbanpour, Tehran, university of social welfare and rehabilitation sciences, Evin avenue, Daneshjo blvd, Kodakyar alley, email adress: <zghorbanpor@yahoo.com>
Ebrahim Pishyareh, Tehran, university of social welfare and rehabilitation sciences, Evin avenue, Daneshjo blvd, Kodak yar alley, email adress: <pishyareh.cog@gmail.com>
What processes are involved for a request to access data/document
after sending emails to researchers and request documentation, the researcher seeks the opinion of other team members regarding the provision of this information and then, If they agree, the documents will be sent as soon as possible. Submission of documents is subject to acceptance of above conditions.