NCT06195748

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

December 23, 2023

Last Update Submit

September 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dynamic balance

    6 weeks

  • Single leg hop test

    6 weeks

  • Single leg vertical jump

    6 weeks

Study Arms (2)

Group A (Kinesiotape Group)

EXPERIMENTAL

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.

Other: Kinesiotaping

Group B (Placebo KT Group)

PLACEBO COMPARATOR

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

Other: Placebo kinesiotaping

Interventions

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.

Group A (Kinesiotape Group)

The same tape will be used for the interventional application with 0 tension.

Group B (Placebo KT Group)

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female students between 18 and 25 years old
  • BMI of 30 kg/ m2 or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12111, Egypt

Location

Related Publications (1)

  • Allam NM, Eladl HM, Elsherbini DMA, Abulfaraj M, Almadani ME, Megahed Ibrahim A, El-Sherbiny M, Eladl MA, Nosseir N, Jamjoom R. Efficacy of ankle Kinesio taping on balance and functional performance in obese female collegiate students: a prospective randomized placebo-controlled trial. Front Public Health. 2025 Aug 11;13:1631757. doi: 10.3389/fpubh.2025.1631757. eCollection 2025.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hadaya M Eladl, PhD

    Assisstant professor of physical therapy for surgery, Faculty of physical therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

December 23, 2023

First Posted

January 8, 2024

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations