Protocol summary

Study aim
The purpose of this study is to investigate the effects of ankle taping on the sole of the foot loading during sit-to-stand in chronic stroke patients
Design
This clinical trial is single group design, and a convenience and an available sampling will be used in this study. Also, twenty chronic stroke patients will participate in this study.
Settings and conduct
This study will be performed at the Neuromuscular Rehabilitation Research Center. Subjects will stand from sitting positions with different foot positions (1.The affected leg will place behind the unaffected leg. 2. The unaffected leg will place behind the affected leg. 3. both legs place symmetrically.) with and without ankle taping randomly. Ground reaction forces in all direction will be measured by force plate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stroke patients should be in the chronic stage and the spasticity score of plantarflexor muscles should be smaller than 3 in the modified Ashworth scale. Exclusion criteria: Medical condition (apart from stroke) that impair patients balance
Intervention groups
Intervention group: Ankle taping on the paretic side is intervention in this study. Kinesio tape (KT) is a thin, highly elastic material which may be used as a modality to correct joint position, increase proprioception, and increase or inhibit muscle recruitment. The KT will be used once in the affected ankle.
Main outcome variables
Vertical ground reaction force, anterior-posterior ground reaction force, medial-lateral ground reaction force

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160424027562N6
Registration date: 2018-09-18, 1397/06/27
Registration timing: prospective

Last update: 2018-09-18, 1397/06/27
Update count: 0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Roghayeh Mohammadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
mohammadipt@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ankle joint taping on the sole of foot loading in sit-to-stand position in chronic stroke patients
Public title
Effects of ankle taping on the sole of foot loading in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients should stand up and sit down independently from a standard chair without using their hands All the patients should be more than 6 months poststroke The spasticity score of plantarflexor muscles should be smaller than 3 in the modified Ashworth scale Stroke patients should be in the chronic stage
Exclusion criteria:
Aphasia Medical condition (apart from stroke) that impair patients balance Skin sensitivity to taping Cognitive deficiency
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.SEMUMS.REC.1397.003

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified

Primary outcomes

1

Description
Vertical ground reaction force
Timepoint
Before and during intervention
Method of measurement
Force plate

Secondary outcomes

1

Description
Anterior - posterior ground reaction force
Timepoint
Before and during intervention
Method of measurement
Force plate

2

Description
Medial - lateral ground reaction force
Timepoint
Before and during intervention
Method of measurement
Force plate

Intervention groups

1

Description
Intervention group: Ankle taping on the paretic side is intervention in this study. Kinesio tape (KT) is a thin, highly elastic material which may be used as a modality to correct joint position, increase proprioception, and increase or inhibit muscle recruitment. The KT will be used once in the affected ankle.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Roghayeh Mohammadi
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mohamadipt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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