This study aims to assess the impact of Kinesio taping on lower limb spasticity among Paralympic athletes.
Design
A randomized, triple-blind, parallel groups controlled trial on 40 patients. Opaque envelopes will be utilized for the randomization.
Settings and conduct
Study location: Physiotherapy clinics of the Rehabilitation Faculty, Tehran University of Medical Sciences; Study population: Paralympic athletes with spasticity; Study design: Patients, assessor, statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
para-athletes with lower limb spasticity in their lower limbs
ability to speak in Persian
18 years or older
exercise for at least six hours per week
Exclusion criteria:
receiving other rehabilitation treatments
other musculoskeletal disabilities
using any medications affecting spasticity
complete paraplegia
Intervention groups
Intervention group: Kinesiotape on the quadriceps and gastrocnemius muscles for two weeks. Control group: Kinesiotape without stretch on the quadriceps and gastrocnemius muscles for two weeks.
Main outcome variables
The level of spasticity in the quadriceps and gastrocnemius muscles using the Modified Modified Ashworth Scale (MMAS); the range of motion of the ankle and knee, balance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052141N3
Registration date:2024-05-24, 1403/03/04
Registration timing:registered_while_recruiting
Last update:2024-05-24, 1403/03/04
Update count:0
Registration date
2024-05-24, 1403/03/04
Registrant information
Name
Amin Nakhostin-Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7797 1942
Email address
a-nansari@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating effects of kinesio tape on spasticity in para-athletes with hypertonia
Public title
Kinesio tape in para-athletes with hypertonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
para-athletes with lower limb spasticity in their lower limbs
ability to speak in Persian
18 years or older
exercise for at least six hours per week
Exclusion criteria:
receiving other rehabilitation treatments
other musculoskeletal disabilities
using any medications affecting spasticity
complete paraplegia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Intervention and placebo labels will be written on paper and placed inside 40 identical envelopes. The secretary will then randomly select an envelope from a box to assign each participant to a group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The assessor and para-athletes will not know which type of intervention is being applied. Additionally, the data analyst will not be informed about the treatment details. The tape used will be of similar shape for both groups, with the distinction that it will not be stretched in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Neuroscience Institute
Street address
Neuroscience Institute, Imam Khomeini Hospital Complex, Gharib street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۳۹
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.TUMS.NI.REC.1400.026
Health conditions studied
1
Description of health condition studied
Spasticity in Paralympic athletes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Spasticity
Timepoint
Before intervention, immediately after intervention, 4 week after intervention
Method of measurement
Modified Modified Ashworth Scale
2
Description
Balance
Timepoint
Before intervention, immediately after intervention, 4 week after intervention
Method of measurement
Brief-BESTest
3
Description
Range of motion
Timepoint
Before intervention, immediately after intervention, 4 week after intervention
Method of measurement
goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Kinesio tape will be applied on the gastrocnemius and quadriceps muscle for two weeks and kinesio tapes will be stretched 25% of their original length
Category
Rehabilitation
2
Description
Control group: Kinesio tape will be applied on the gastrocnemius and quadriceps muscle for two weeks and kinesio tapes will not be stretched.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Street address
School of Rehabilitation; Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Neuroscience Institute, Imam Khomeini Hospital Compelx, Gharib street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۳۹
Phone
+98 21 6658 1701
Email
tini@tums.ac.ir
Grant name
Grant code / Reference number
51539
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will become available upon deidentification.
When the data will become available and for how long
The data will be available upon the completion of the study.
To whom data/document is available
Other Researchers
Under which criteria data/document could be used
Data may be used for research purposes.
From where data/document is obtainable
Applicants should email prof. Nakhostin Ansari at nakhostin@tums.ac.ir
What processes are involved for a request to access data/document
The data will be will be available from the corresponding author upon reasonable request.