The aim of this study is to examine the effect of compression socks on the postural stability in people with stroke.
Design
The design of this study is double-blind, non-randomised sham controlled clinical trial with parallel groups.
Settings and conduct
The participants will be selected from stroke survivors who are referred to rehabilitation centres in Tehran University of Medical Science. The design is single-blinded in which only participants will be blinded to the type of intervention and aims.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hemiplegia in the right or left side of the body; independency in sit-to-stand; more than 2 months after stroke incident; both genders.
Exclusion criteria: unable to sit and stand independently; older than 80 years; poor motor functions according to their score in MAS <24 and TUG >120 sec; poor cognitive function.
Intervention groups
The participants will be selected non-randomly and will be allocated to intervention and control groups according to clinical measurement results. The intervention group will use compression socks for 2 weeks (3 days per week), whereas the control group use normal socks in the same time period.
Main outcome variables
Body sway: the ability to posture within the base of support area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100202003259N3
Registration date:2018-03-23, 1397/01/03
Registration timing:prospective
Last update:2018-03-23, 1397/01/03
Update count:0
Registration date
2018-03-23, 1397/01/03
Registrant information
Name
Noureddin Nakhostin Ansari
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
nakhostin@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of wearing compression versus normal socks on postural stability during sitting-to-standing task performance in people with stroke
Public title
Effects of wearing compression socks on balance of people with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who suffering stroke in left or right side of the body
Ability to sit and stand without assistance
The onset of stroke is more than 2 months
Both males and females
Exclusion criteria:
People with severe disability who cannot sit and stand
Age above 80 years
Poor motor function in lower limbs that is assessed by TUG and MAS tests
Sever cognitive function and poor attention
Age
From 18 years old to 80 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)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The assistant therapists who are responsible to collect data are not aware of the type of socks during the intervention period. In addition, participants cannot recognise the type of socks and the outcomes of this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.IUMS.REC 1396.31376
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Body sway:The ability to maintain the posture within base of support area.
Timepoint
Each participant will be tested in 3 conditions: Pre-test, 1 day after the end of the intervention period (post-test) with normal socks and with compression socks.
Method of measurement
Lab test with PT posture scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group with compression socks: The intervention group will receive medical compression socks that are customised according to their foot size. The compression socks are standardised in terms of pressure (20-40 mmHg) and texture (nylon 72%; lycra 28%; Finland Zero, Co). They will wear the socks 3 hours per day for 12 days. The instructions for the time and duration and procedure will be given in advance for consistency. They will receive a short message to remind them of the time and duration during the intervention period. In addition, participants record the daily time usage in their diary.
Category
Rehabilitation
2
Description
Control group: Normal socks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Bijan Forogh
Street address
Firozgar Hospital, Behafarin Ave, Valiasr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
bijanfr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakoti
Street address
Iran University of Medical Sciences, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Neuromusculoskeletal Research Center
Grant code / Reference number
96-02-217-31376
Is the source of funding the same sponsor organization/entity?