ObesityNCT06195748
Ankle Kinesio Taping on Balance and Functional Performance in Obese Females.
A study testing Kinesiotaping in people with Obesity, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female students between 18 and 25 years old
- BMI of 30 kg/ m2 or more
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ankle Kinesio Taping on Balance and Functional Performance in Obese Female Collegiate Students
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Kinesiotaping, Placebo kinesiotaping
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
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 kinesiotapingOther
The same tape will be used for the interventional application with 0 tension.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Placebo kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
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
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Study director, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195748
- Sponsor's protocol ID
- IRB Approval No. 2023-124
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40860562
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ankle Kinesio Taping on Balance and Functional Performance in Obese Female Collegiate Students
- ClinicalTrials.gov ID
- NCT06195748
- Acronym / sponsor ID
- IRB Approval No. 2023-124
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Kinesiotape Group) | Experimental | Other: KinesiotapingThe 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. |
| Group B (Placebo KT Group) | Placebo comparator | Other: Placebo kinesiotapingThe 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female students between 18 and 25 years old
- BMI of 30 kg/ m2 or more
Key exclusion criteria (7 listed)
- Orthopedic or neurosurgery injury past 6 months
- Ankle edema
- Skin allergy to the tape
- Abnormalities of the nervous system
- Any previous history of injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapingAccording 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 | Group A (Kinesiotape Group) |
| Placebo kinesiotapingThe same tape will be used for the interventional application with 0 tension. | Other | Group B (Placebo KT Group) |
Primary outcome
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.
3 secondary outcomes
Dynamic balance
Time frame: 6 weeks
Single leg hop test
Time frame: 6 weeks
Single leg vertical jump
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40860562Allam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadaya M Eladl, PhD study director
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping in people with Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.