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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06195748
Other study ID # IRB Approval No. 2023-124
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date June 1, 2024

Study information

Verified date January 2024
Source Cairo University
Contact Nesma M Allam, PhD
Phone +201281968332
Email dr.nesma2011@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is one of the most dangerous factors affecting the joints, which must be prevented due to arthritis and the long-lasting, tiring effects that affect a person's life [1], The most important of these are foot problems due to weight and excess pressure, It is also one of the factors that greatly affects walking movement because it increases the load on joint movement, This increases the risk of musculoskeletal diseases.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesiotaping
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 kinesiotaping
The same tape will be used for the interventional application with 0 tension.

Locations

Country Name City State
Egypt Faculty of Physical Therapy Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Static balance 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 Dynamic balance 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. 6 weeks
Secondary Single leg hop test 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 6 weeks
Secondary Single leg vertical jump 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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