The aim of this study is to Compare effects of Kinesio taping with or without conventional physical therapy in obese women with pes planus.
Design
A single blinded randomized controlled trial, conducted on 72 patients, equally divided into two groups, single centered study.
Settings and conduct
The university of Lahore teaching hospital, single blinded study.
Participants/Inclusion and exclusion criteria
Age of young adults (25-60) years having navicular drop with BMI Body mass index (BMI, kg/m2) above(<25) considering obese female are included and Skeletal or structural injury of lower extremities, Ankle sprain or surgery within 6 months, Any nervous system diseases or Any nervous system diseases are excluded.
Intervention groups
70 patients will be randomly divided into control and experimental groups. The control group will receive kinseio taping while the experimental group will receive kinesio taping along with conventional physical therapy.
Main outcome variables
Navicular Drop, Foot Functionality.
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20230703058650N1
Registration date:2023-08-17, 1402/05/26
Registration timing:registered_while_recruiting
Last update:2023-08-17, 1402/05/26
Update count:0
Registration date
2023-08-17, 1402/05/26
Registrant information
Name
Zainab Nasrullah
Name of organization / entity
The University of lahore
Country
Pakistan
Phone
+92 308 1026277
Email address
zainab.nasrullah@admin.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-15, 1402/05/24
Expected recruitment end date
2023-10-20, 1402/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effect of Kinesio taping with and without conventional physical therapy in obese women with pes planus.
Public title
Comparative Effect of Kinesio taping with and without conventional physical therapy in obese women with pes planus.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Age of young adults (25-60) years
• Having a navicular drop distance
• Obese Females Body mass index (BMI, kg/m2) above(<25
Exclusion criteria:
• Skeletal or structural injury of lower extremities
• Ankle sprain or surgery within 6 months
• Any nervous system diseases
• Any lower limb deformities
• Unwillingness to continue the study
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
By using computer generated random number table, patients will be randomly assigned into two groups. All
those random numbers will be enclosed in sealed envelopes. A third person (who will further not be the
part of research) will open envelops and the patients will be allocated to the mentioned group accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients
Before intervention and after 4 weeks of intervention
Method of measurement
Staheliplanter Arch Index, Navicular Drop Test (NDT), Foot Function Index
Secondary outcomes
1
Description
Foot Functionality
Timepoint
Before intervention and after 4 weeks of intervention
Method of measurement
Foot Function Index
Intervention groups
1
Description
Group A: This group will receive kinesio taping , Kinesio Tape (KT) applied In the prone position, the participants flexed their knee and 3 strips of Kinesio tape (Kinesio® TexGoldTM FP, U.S.A) with 100% tension in the middle were applied on the transverse arch, aiming to enhance its static stability. Another strip of Kinesio tape with 75% tension was applied on the tibialis posterior, from the fifth metatarsal head, around the navicular and posterior medial malleolus to half of the tibia. The tapes were warmed by rubbing them immediately after application to maximize adhesion.
Category
Treatment - Other
2
Description
Group B: This group will receive kinesio taping (KT) with conventional physical therapy exercises Heel raises: Patient was in standing position and has to perform heel raises 20 times. (Without shoes),TA Stretching: The patient was taken in supine position Researcher was positioned to side of the patient and applied a passive stretch leading to 30 sec hold and was repeated 5 times each session, Toe Spreading exercises: The patient was in sitting or standing position and shall be instructed to stabilize the ball of the foot on the ground while lifting and spreading out the toes, Frequency: 20 times, intensity: 5 sec holds, type of contraction: isometric contraction ,Toe extension exercises: The patient was in sitting or standing position and was instructed to lift the big toe against the floor. Frequency: 20 times, intensity: 5 sec holds, type of contraction: isometric contraction Each exercise will be of 2 sessions a day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Lahore Teaching Hospital
Full name of responsible person
Zainab Nasrullah
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
lahore
Postal code
54000
Phone
+92 308 1026277
Email
zainab.nasrullah@admin.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Zainab Nasrullah
Street address
university of lahore
City
LAHORE
Postal code
54000
Phone
+92 302 6099150
Email
Zainabnasrullah123@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Lahore
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
The University of Lahore, Pakistan
Full name of responsible person
Zainab Nasrullah
Position
Officer
Latest degree
Bachelor
Other areas of specialty/work
Administration
Street address
the university of lahore main campus near bhobatian chowk
City
LAHORE
Province
Punjab
Postal code
00
Phone
+92 308 1026277
Email
zainabnasrullah123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Zainab Nasrullah
Position
Officer
Latest degree
Bachelor
Other areas of specialty/work
Administration
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 308 1026277
Email
zainab.nasrullah@admin.uol.edu.pk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Zainab nasrullah
Position
Officer
Latest degree
Bachelor
Other areas of specialty/work
Admin
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 308 1026277
Email
zainab.nasrullah@admin.uol.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
All collected identified IPD
When the data will become available and for how long
Data will be available after the completion of study and will remain available till 6 months
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator "Zainab Nasrullah" on email address "zainabnasrullah123@gmail.com".
From where data/document is obtainable
Zainab Nasrullah, zainabnasrullah123@gmail.com
What processes are involved for a request to access data/document
The data/document can be accessed through communicating with the principle investigator "Zainab Nasrullah" on email address "zainabnasrullah123@gmail.com".