Protocol summary

Summary
Stroke patients suffer from balance impairment related to disturbed ankle joint position sense. The aim of this study is to investigate the effect of taping on ankle joint position sense in chronic stroke patients. 20 patients, available in university clinic will participate in this study, and ankle joint taping will be used for 48 hours. All the participants would be more than 6 months post-stroke. Therefore active and passive joint position senses index will be measured before and after intervention by Biodex Isokinetic System.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010427562N3
Registration date: 2017-02-14, 1395/11/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-14, 1395/11/26
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
Govermental
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of taping on ankle joint position sense in chronic stroke patients
Public title
Effect of taping on ankle joint position sense
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients should be more than 6 month post stroke; subjects should be in rang of 45-70 years old; their Berg balance scale should be less than 40 score. Exclusion criteria: any condition except stroke that impaired their balance; sever aphasia; sever cognitive deficient
Age
From 45 years old to 70 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, 5 kilometer of Damghan Road, Semnan
City
Semnan
Postal code
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.SEMUMS.REC.1395.160

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Active ankle joint position sense
Timepoint
Before and after intervention
Method of measurement
Biodex Isokinetic System

Secondary outcomes

1

Description
Passive ankle joint position sense
Timepoint
Before and after intervention
Method of measurement
Biodex Isokinetic System

Intervention groups

1

Description
Ankle joint taping will be used on affected side for 48 hours.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Roghayeh Mohammadi
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research Affairs of Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidy-pour
Street address
Second floor, Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research Affairs of Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

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
Other areas of specialty/work
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

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
Other areas of specialty/work
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Postal code
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
Other areas of specialty/work
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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