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The Comparative Effectiveness of Mobilizations with Movement and Kinesio tape in Lateral Ankle Sprain; A randomized clinical trial

Protocol summary

Study aim
To evaluate the combined effect of Kinesio tape and MWM on lateral ankle sprain.
Design
Randomized clinical design
Settings and conduct
The study will done on patients of the acute, the sub acute stage of grade I, II lateral ankle sprain and patients will selected from Al-Fateh Sports Complex Faisalabad and DHQ hospital Faisalabad. participants after fullfilling the inclusion and exclusion creteria participants will selected for study and then divided into two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Unilateral lateral ankle sprain, Grade II and grade I lateral ankle sprain (Kim, et al., 2018),Positive anterior drawer test (Kim, et al., 2018), Positive talar tilt test, Age of patient 15 to 30 years, Both male and female (b) Exclusion criteria: • Fracture in distal end of tibia and fibula (Kim, et al., 2018). Open wound at ankle joint (Hudson, et al., 2017). Sprain more than 72 hours.Patients having loss of ankle function by <5 degree (Shin, et al., 2020). Sensory loss at the ankle due to neurological issue (Kim, et al., 2018). Patients having skin diseases,Grade III ankle sprain.
Intervention groups
. Then patients will randomly assigned in the two groups, Experimental group (group A) and the control (group B). The Experimental group receives 3 sets of 10 MWM repetitions in one treatment session and 30 sec of rest in each set and KT tapping 3 sessions a week for 4 weeks. Control B received KT tapping 3 sessions a week for 4 weeks. Pre and Post intervention patients conditions will assess by the NRS, DPA- scale and the PSFS scale.
Main outcome variables
NRS Numeric rating scale for pain. Patient specific functional scale (PSFS) for functional activity status.3 Disablement in physically active scale (DPA scale):This scale is used to gather data about disablement in four dimensions impairment,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210825052283N1
Registration date: 2021-10-10, 1400/07/18
Registration timing: retrospective

Last update: 2021-10-10, 1400/07/18
Update count: 0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Aqsa Noreen
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8372510
Email address
mspp-fa19-002@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-10, 1400/06/19
Expected recruitment end date
2021-09-20, 1400/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Effectiveness of Mobilizations with Movement and Kinesio tape in Lateral Ankle Sprain; A randomized clinical trial
Public title
The Comparative Effectiveness of Mobilizations with Movement and Kinesio tape in Lateral Ankle Sprain; A randomized clinical trial
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1. Unilateral lateral ankle sprain• 2. Grade II and grade I lateral ankle sprain (Kim, et al., 2018). 3.Positive anterior drawer test (Kim, et al., 2018) 4.Positive talar tilt test 5.Age of patient 15 to 30 years 6.Both male and female
Exclusion criteria:
1. Fracture in distal end of tibia and fibula (Kim, et al., 2018).• 2.Open wound at ankle joint (Hudson, et al., 2017) 3.Sprain more than 72 hours• 4.Patients having loss of ankle function by <5 degree (Shin, et al., 2020) 5.Sensory loss at the ankle due to neurological issue (Kim, et al., 2018). 6.Patients having skin diseases 7.Grade III ankle sprain
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
The randomizationof participants will accomplished by using simple random sampling.For the random allocation of participants into groups, a lottery method will be used , where participants will have equal chance of getting enrolled into any of two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study will be conducted in sports complex Faisalabad and DHQ hospital Faisalabad. Non probability Sampling; convenient sampling technique.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics and Technical Committe of The University of Faisalabad
Street address
The university of faisalabad Sargodha road
City
Faisalabad
Postal code
3800
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
tuf/Addl Reg/A-14/126

Health conditions studied

1

Description of health condition studied
Acute and sub acute stage of lateral ankle sprain
ICD-10 code
S93.41
ICD-10 code description
Sprain of calcaneofibular ligament

Primary outcomes

1

Description
reduction in lateral ankle sprain pain
Timepoint
after 4 weeks of intervention
Method of measurement
Different scale like numeric rating scale.

Secondary outcomes

1

Description
Patient specific functional scale (PSFS)This scale is used to collect data about Functional activity status. This scale is used to assess the patient’s functional status and activity limitation. Disablement in physically active scale (DPA scale) This scale is used to gather data about disablement in four dimensions impairment.
Timepoint
after 4 weeks of intervention
Method of measurement
Patient specific functional scale (PSFS)This scale is used to collect data about Functional activity status. This scale is used to assess the patient’s functional status and activity limitation. Disablement in physically active scale (DPA scale) This scale is used to gather data about disablement in four dimensions impairment.

Intervention groups

1

Description
intervention group:• 3 set of 10 MWM repetitions in one treatment session and the 30 sec of rest in each set. KT tapping 3 sessions a week for one month. Pateint in sitting position with leg straight. Physiotherapist grasp the patients’s distal fibula by thenar eminence and thenar eminence of opposite hand grasp the distal tibal. Physiotherapist apply the posterio cranial glide along with MWM and asked patient to actively perform the dorsiflexion range of motion of that ankle. A 75cm cohesive elastic bandage use. At start I shape Kinseiotape is applied by distal end of foot and move toward the proximal end It is started from medial side of foot and then from lateral side and at the wraps in circular direction so whole ankle is covered so that figure 8 shape tape is applied so the dorsum of foot is covered (kim, et al., 2018).
Category
Treatment - Other

2

Description
Control group:•KT tapping 3 sessions a week for one month .A 75cm cohesive elastic bandage use. At start I shape Kinseiotape is applied by distal end of foot and move toward the proximal end It is started from medial side of foot and then from lateral side and at the wraps in circular direction so whole ankle is covered so that figure 8 shape tape is applied so the dorsum of foot is covered (kim, et al., 2018).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
DHQ Hospital Faisalabad
Full name of responsible person
Aqsa Noreen
Street address
DHQ Hospital Faisalabad
City
Faisalabad
Postal code
3800
Phone
Email
aqsanoreen49@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Al fateh sports complex
Full name of responsible person
Aqsa Noreen
Street address
Al fateh sports complex Faisalabad
City
Faisalabad
Postal code
3800
Phone
Email
aqsanoreen49@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University f Faisalabad
Full name of responsible person
Dr. Sidra Majeed
Street address
The University f Faisalabad Sarghodha road Faisalabad
City
Faisalabad
Postal code
3800
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self financed
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Position
Assistant prof
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences Department The University of Faisalabad
City
Faisalabad
Province
Punjab
Postal code
3800
Phone
+92 41 8868326
Email
sidra.majeed@tuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Position
Assistant prof
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences Department The University of Faisalabad
City
Faisalabad
Province
Punjab
Postal code
3800
Phone
+92 41 8868326
Email
sidra.majeed@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences Department The University of Faisalabad
City
Faisalabad
Province
Punjab
Postal code
3800
Phone
+92 41 8868326
Email
sidra.majeed@tuf.edu.pk

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
THE COMPARATIVE EFFECTIVENESS OF MOBILIZATION WITH MOVEMENT (MWM) AND KINESIO TAPE IN LATERAL ANKLE SPRAIN: A RANDOMIZED CLINICAL TRIAL
When the data will become available and for how long
After complete research it will be available
To whom data/document is available
it will be try to show the results of this research for medical as well as general population
Under which criteria data/document could be used
it will be try to show the results of this research for medical as well as general population
From where data/document is obtainable
internet,articles,thesis
What processes are involved for a request to access data/document
Data will be available publically
Comments
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