The aim of this study is to investigate the effect of inhibitory kinesiotaping on motor neuron excitability and spasticity of plantar flexor muscles in the affected limb of patients with chronic cerebrovascular attack
Design
In this pilot study 30 chronic patient that have the inclusion criteria are selected and randomly divided into control and intervention groups.
Settings and conduct
The Hmax/Mmax ratio (as a measure of motor neuron excitability) of the Gastrosoleous and the Modified Ashworth Scale (MAS)(as a measure of muscle spasticity) will be calculated before, 30 minutes after and 48 hours after taping. To control the effect of Anxiety on H reflex , SpilbergerState-Trait Anxiety Inventory will be used.
Participants/Inclusion and exclusion criteria
Patient with first attack of stroke and Modified Ashworth Scale (MAS) of paretic ankle plantar flexor more than 1 with no history of neuromuscular disease and neuropathy and radiculopathy will be selected to enter the study.
Intervention groups
The experimental group receives Kinesiotaping on Gastrosoleous muscles of affected limb and the control group receives no intervention.
Main outcome variables
The Hmax/Mmax ratio (as a measure of motor neuron excitability) of the Gastrosoleous; The Modified Ashworth Scale (MAS) will be used(as a measure of muscle spasticity)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090831002391N17
Registration date:2018-01-04, 1396/10/14
Registration timing:prospective
Last update:2018-01-04, 1396/10/14
Update count:0
Registration date
2018-01-04, 1396/10/14
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Expected recruitment start date
2018-01-06, 1396/10/16
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Kinesiotaping on motor neuron excitability and spasticity in chronic stroke patients
Public title
Effect of Kinesiotaping on motor neuron excitability and spasticity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with first attack of stroke
Patient with Modified Ashworth scale (MAS) of paretic ankle plantar flexor more than 1
No history of neuromuscular disease
No history of a previous neurological disorder
Chronic stroke patient (at least 6 months after stroke attack)
Patient do not receive any physical therapy in last month
Patient with low grade in Spilberger State-Trait Anxiety Inventory
Exclusion criteria:
Patient who have fixed muscle contractures at the ankle joint (grade 4 in MAS score)
Patients that receiving antispasticity drugs
Patients that had hemiplegia due to traumatic brain injury
Any history of lower limb surgery
Fracture or joint dislocation in the lower limb
Diabetes mellitus
Neuropathy
S_1 Radiculopathy
Allergy to the Kinesiotape
Normal absence of H reflex in some people
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method will be used for random allocation of individuals to intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research in Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SUMS.REC.1395.197
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I64
ICD-10 code description
stroke, not specified as heamorrage or infarction
Primary outcomes
1
Description
H max/M max ratio
Timepoint
Before intervention, 30 minute and 48 hours after intervention
Method of measurement
With electromyography The Hmax/Mmax ratio of gastrosoleus will be calculated
2
Description
Modified Ashworth Scale
Timepoint
Before intervention, 30 minute and 48 hours after intervention
Method of measurement
To investigate the muscle spasticity we will used the Modified Ashworth Scale.
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group receives Kinesiotaping on Gastrosoleous muscles of affected limb
the control group receives no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd shahid sadooghi hospital
Full name of responsible person
Mahdad Mehraein
Street address
Shahid ghandy Blvd, Ebne Sina Ave, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 9009
Email
mahdad_2000m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Science, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
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, Shiraz 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
School of Rehabilitation Sciences
Full name of responsible person
Mahdad Mehraein
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 2495
Fax
Email
mahdad_2000m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
consultant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Rehabilitation Sciences
Full name of responsible person
Mahdad Mehraein
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 2495
Fax
Email
mahdad_2000m@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
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