- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06195748
Ankle Kinesio Taping on Balance and Functional Performance in Obese Females.
The Effect of Ankle Kinesio Taping on Balance and Functional Performance in Obese Female Collegiate Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It had been reported that obese subjects have a higher prevalence of falls and ambulatory stumbling or a loss of balance than their non-obese counterparts. Excess weight increases the stress within the bones, joints, and soft tissues, resulting in impaired musculoskeletal function. such as abnormal mechanics of the body. These impairments, such as impaired balance, gait, strength, sensory function, and neuromuscular function have been identified as strong risk factors for falls.
Participants that are eligible to participate to the study will be distributed into two groups: Group A will receive ankle kinesiotaping on the dominant leg. While, Group B will receive placebo kinesiotaping on the dominant leg. The treatment duration will be 6 weeks for both groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nesma M Allam, PhD
- Phone Number: +201281968332
- Email: dr.nesma2011@yahoo.com
Study Locations
-
-
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Giza, Egypt, 12111
- Recruiting
- Faculty of physical therapy
-
Contact:
- Nesma M Allam, PhD
- Phone Number: +201281968332
- Email: dr.nesma2011@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female students between 18 and 25 years old
- BMI of 30 kg/ m2 or more
Exclusion Criteria:
- Orthopedic or neurosurgery injury past 6 months
- Ankle edema
- Skin allergy to the tape
- Abnormalities of the nervous system
- Any previous history of injury
- Use of medication in the past 3 months
- Regular physical activity at least three times a week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (Kinesiotape Group)
The technique will follow manufacturer's guidelines, which is described in the Kinesio taping method.
According to the manufacturer, the controllable variables in KT application included degree of pre-stretch applied to the tape (75-100%), the location and treatment goals.
The subject will be asked to lie supine, with the ankle of the dominant side in neutral position.
A Y shaped KT strip will be applied from the heel to lateral and medial femoral condyles.
A I shaped KT strip will be applied from medial malleolus to lateral malleolus, passing under the heel.
Another I shaped KT strip will be applied from slightly above the medial malleolus to slightly above the lateral malleolus, crossing on the instep at the malleoli level.
|
According to the manufacturer, the controllable variables in KT application included degree of pre-stretch applied to the tape (75-100%), the location and treatment goals.
The subject will be asked to lie supine, with the ankle of the dominant side in neutral position.
A Y shaped KT strip will be applied from the heel to lateral and medial femoral condyles.
A I shaped KT strip will be applied from medial malleolus to lateral malleolus, passing under the heel.
Another I shaped KT strip will be applied from slightly above the medial malleolus to slightly above the lateral malleolus, crossing on the instep at the malleoli level.
|
Placebo Comparator: Group B (Placebo KT Group)
The same tape will be used for the interventional application.
Two strips will be used, one from the heel to the proximal third of the leg, the other from the lateral malleolus to the medial malleolus crossing on the instep, both with 0 tension
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The same tape will be used for the interventional application with 0 tension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static balance
Time Frame: 6 weeks
|
Single leg stance test: It is used for assessment of static balance.
The participants will be instructed to close their eyes, stand barefoot on the dominate and then on non-dominant leg, and elevate the other limb so that it is close to but not touching the ankle of the limb on which they are stanced.
The individual will be told to cross her arms over her chest before lifting the limb.
The length of time the person can stand on one leg will be timed by the investigator using a stopwatch.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic balance
Time Frame: 6 weeks
|
the Biodex Balance System (BBS) SD (12.1-inch [30.7-cm] display, 115 VAC; Biodex Medical Systems Inc., Shirley, NY, USA).
The BBS measures stability indices, which represent the variance of foot platform displacement in degrees for motion in different planes.
The platform is fixable and movable.
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6 weeks
|
Single leg hop test
Time Frame: 6 weeks
|
The students will be asked to perform a maximum forward jump and land on the tested leg (first with the dominant, then with the non-dominant) while maintaining a two-second landing posture.
The distance between the rear foot at landing and the start point will be measured in centimeter after being normalized to the subject leg length.
The test result will be calculated as the average of the two best performances out of three trials
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6 weeks
|
Single leg vertical jump
Time Frame: 6 weeks
|
The students will be advised to stand on one leg, approximately one foot from the wall, and use the index finger to mark the wall as a reference point.
Then they will jump on one leg (the dominant) three times and then the other leg (the non-dominant) three times.
The difference between these two points was determined in centimeter, and the test result will be recorded as an average.
|
6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hadaya M Eladl, PhD, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB Approval No. 2023-124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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