Evaluation of the effect of using shoulder support in reducing shoulder subluxation in people with stroke
Design
A clinical trial with a control and intervention group; single-blind; 50 patients; simple randomization method used for randomization.
Settings and conduct
The study is performed on patients who are referred to Rofideh Rehabilitation hospital from October 1400. Subjects are randomly assigned (using the day of referral: odd days for the intervention group and even days for the control group) in two groups of 25 as a control group: routine intervention and intervention group: common occupational therapy intervention and shoulder support. The person making the necessary assessments is blind to assigning people to the groups.
Participants/Inclusion and exclusion criteria
Be a volunteer to enter the study; Occurrence of stroke; Less than two years have passed since the stroke; Occurrence of partial subluxation in the shoulder joint; No history of the orthopedic shoulder joint disease.
Intervention groups
Intervention group: Performing rehabilitation exercises, in addition to the use of support shoulder throughout the day.
Control group: Rehabilitation exercises.
Main outcome variables
Shoulder subluxation; Pain; upper limb function.
General information
Reason for update
Acronym
ESHS
IRCT registration information
IRCT registration number:IRCT20210620051636N1
Registration date:2021-09-18, 1400/06/27
Registration timing:prospective
Last update:2021-09-18, 1400/06/27
Update count:0
Registration date
2021-09-18, 1400/06/27
Registrant information
Name
Zahra Miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 0445
Email address
zahra.ot22@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of shoulder support on improvement of shoulder subluxation in people with stroke
Public title
Effect of shoulder support on improvement of shoulder subluxation in people with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be volunteer to enter the study
History of stroke
Passing less than two years of stroke
Age between 18 to 60
Having subluxation
Exclusion criteria:
History of having orthopedic disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization. By day of reference, odd day intervention group, even day control group
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator who conducts the assessments does not know the participants' groups.
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
Street address
Koodakyar street, Daneshjoo Blvd , Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.USWR.REC.1400.132
Health conditions studied
1
Description of health condition studied
Shoulder subluxation
ICD-10 code
S43.0
ICD-10 code description
Subluxation and dislocation of shoulder joint
Primary outcomes
1
Description
Shoulder subluxation
Timepoint
Before the intervention, three and seven weeks after
Method of measurement
By ultrasound machine and by a specialist doctor
Secondary outcomes
1
Description
pain
Timepoint
Before the intervention, three weeks and seven weeks later
Method of measurement
visual analogue scale
2
Description
Upper limb function
Timepoint
before the intervention Three and seven weeks later
Method of measurement
fugel mayer assessment
Intervention groups
1
Description
Intervention group: Routine occupational therapy interventions will selected during a control panel and performed in 15, 45 minutes, sessions. In addition, they will use the support shoulder at all hours of the day.
Category
Rehabilitation
2
Description
Control group: Routine occupational therapy interventions will selected during a control panel and performed in 15, 45 minutes, sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofeideh Rehabilitation hospital
Full name of responsible person
Zahra Miri
Street address
Andarsgoo blvd
City
Tehran
Province
Tehran
Postal code
1122232741
Phone
+98 21 23570
Fax
Email
rofeideh.hospital@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr Ebrahim Pishyareh
Street address
Koodakyar street, Daneshjoo blvd, Evin
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 miri
Position
Occupational therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No 221 Ghafari street Kamali street
City
Tehran
Province
Tehran
Postal code
9619643436
Phone
+98 21 4429 0445
Email
zahra.ot22@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Miri
Position
Occupational therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No.121 Kamali Ave, south kargar,
City
Tehran
Province
Tehran
Postal code
9619643436
Phone
+98 51 4429 0445
Fax
Email
zahra.ot22@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra miri
Position
Occupational therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No 221 Ghafari street Kamali street
City
Tehran
Province
Tehran
Postal code
9619643436
Phone
+98 21 4429 0445
Email
zahra.ot22@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
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
Title and more details about the data/document
results
When the data will become available and for how long
a few months after
To whom data/document is available
every one
Under which criteria data/document could be used
informing people
From where data/document is obtainable
zahra miri rofideh hospital
What processes are involved for a request to access data/document