Ankle InjuriesNCT06499935
The Effect of Taping on Plantar Pressure Distribution in Players With Chronic Ankle Instability
A study testing Rigid Taping and Kinesio-Taping in people with Ankle Injuries and Ankle Injuries and Disorders, run by Cairo University at 1 site in Lebanon.
Trial summary
The goal of this study is to investigate whether there exists a difference in baropdometric readings of plantar pressure between individuals with chronic ankle instability and normal health individuals, in addition another goal of this study is to investigate the effect of rigid taping vs. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Ankle Injuries and Disorders, Ankle Sprains
- What is being tested?
- Rigid Taping and Kinesio-Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteLebanon
- Study dates
- 24 May 2024to 25 Oct 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A history of at least 1 significant ankle sprain
- The initial sprain must have occurred at least 12 months before study enrollment
- A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
- Cumberland Ankle Instability Tool: score of 24 or less
Who cannot join
- A history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either lower extremity
- A history of a fracture in either lower extremity requiring realignment
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (i.e., sprains, fracture) resulting in at least 1 interrupted day of desired physical activity.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Ahmed M. El Melhat
Beirut, 0000
Ahmed Mohammed El Melhat, PhD, 20 1112595022, a.melhat@bau.edu.lb
About this study
Official title: The Immediate Effects of Rigid Taping Versus Kinesio-Taping on Plantar Pressure Distribution in Basketball Players With Chronic Ankle Instability
The goal of this study is to investigate whether there exists a difference in baropdometric readings of plantar pressure between individuals with chronic ankle instability and normal health individuals, in addition another goal of this study is to investigate the effect of rigid taping vs. kinesio taping on plantar pressure distribution as well as stability markers in individuals with chronic ankle instability.
The main questions aimed to answer are:
Read more
- Is there a difference in plantar pressure distribution between individuals with chronic ankle instability and individuals without chronic ankle instability?
- What effect do rigid and kinesio taping have on plantar pressure distribution and ankle stability markers?
- Which tape affects plantar pressure distribution and ankle stability better?
Participants will:
Firstly be divided into two macro groups, one with chronic ankle instability and one without, with an observational part of the study to be carried out to investigate the differences in plantar pressure between both groups.
Secondly, the group with chronic ankle instability will be divided into two micro groups one receiving rigid taping and the other receiving kinesio taping, and the immediate effects of these tapes in terms of plantar pressure and ankle stability will be recorded and compared before and after within groups, and after between both groups.
Read the detailed description
Basketball players frequently suffer from lateral ankle sprains and multiple repetitions can cause chronic ankle instability. The authors contend that professional basketball can no longer be regarded as a noncontact sport because of the rising rate of injuries to players in the league. An orthopedic strapping treatment for the foot called rigid taping involves applying tape along the plantar part of the foot and inferior to the malleoli.
Another type of taping method gives the musculoskeletal system external support, kinesio-taping has long been employed in the rehabilitation and prevention of sports-related injuries in athletes and sports participants. The goal of an anti-pronation taping technique is to constrain an overpronated foot by offering temporary external support.
Thus the aim of this study is to determine the immediate effects of rigid taping versus kinesio-taping on static and dynamic plantar pressure distribution in basketball players with chronic ankle instability. An explanation of the procedure and a written consent form will be provided, and the assessment will be taken at the beginning of the spring semester of 2024/2025 for inclusion and exclusion. Then the CAIT will be used followed by assigning the participants into a healthy group and an injured group for the observational part and collecting the data on the injured foot. Then further randomly divided the injured group into AP, LD, and a control group. Application of the interventions will be done to the affected foot and sham tape will be applied to the control group then the effects will be observed and the measurements will be noted and compared to the previous data. The CAIT will be used again to observe the differences that may result. The study will take place at Mousawat Institution.
- Conditions
- Ankle Injuries, Ankle Injuries and Disorders, Ankle Sprains
- Being tested
- Rigid Taping, Kinesio-Taping, Sham Taping
- Medical subject headings
- Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid TapingOther
It is usually light brown or beige and is designed to hold firm, making it ideal for providing support or stability to a joint.
Kinesio-TapingOther
Kinesio Taping Method is a therapeutic tool utilised by rehabilitation specialists in all programs. Kinesio Taping Method utilises four types of Kinesio Tex Tapes, each with specific properties designed for use on fragile, sensitive skin or applied with higher tensions.
Sham TapingOther
Sham taping is the use of any type of tape in a random and ineffective fashion for the purposes of comparison with other taping techniques and types.
| Study group | Role | What they receive |
|---|---|---|
| Rigid Taping Group | Experimental | A single application of tape will be fastened to the fibula's lateral malleolus, extended beneath the foot, and crossed the medial foot at the calcaneus and navicular tuberosity. After that, it will wrapped around the fibular and tibial shafts and passed across the anterior part of the ankle. The tape will be applied similarly to the other application, with 1.5 inches of overlap between the strips. Receives: Other: Rigid Taping |
| Kinesio Taping Group | Experimental | Elastic kinesiology tape will be employed in this investigation. Patients will be comfortably positioned on a table raised sufficiently so that their feet couldn't contact the ground. At the hindfoot, a 2-inch, 25-centimeter strip will be applied, stretching it seventy-five percent from the middle third of the medial tibia to the fibula (lateral malleolus), around the calcaneus. Applying the strip in the maximally supinated position while going in the direction mentioned will allow the foot to eventually reach its maximum dorsal flexion. The interior aspect of the tibial bone and fibula will then wrapped Receives: Other: Kinesio-Taping |
| Sham Taping Group | Sham comparator | There are two steps to Sham taping: The internal malleolus is the starting point of the first stage, which extends to the lower limb's inner middle point. The second stage starts at the external malleolus and extends to the lower limb's outer middle point. Receives: Other: Sham Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baropodometric measurements of plantar pressure distribution.
The plantar pressure data will be measured during single-leg stance and natural walk using the Gaitview (®) AFA-50 system (alFOOTs, Seoul, Republic of Korea). The pressure platform included a 410 × 410 × 3 mm active area consisting of a 45-mm thick floor mat (700 × 500 mm), comprising 2,304 (48 × 48) force-sensitive resistor sensors and sampling data at 17 Hz (Kim et al., 2012). An investigation of the reliability of the Gaitview® system using the two-step gait-initiation method was done. It demonstrated good to moderate reliability for measuring plantar pressure, and that it is suitable for use in clinical and research trials (Kim et al., 2012). Data will be recorded and saved using the same device.
Measured: immediately after the intervention
Secondary outcomes (1)
Ankle Stability
Cumberland ankle instability Tool (CAIT) will be completed for each participant to measure the functional ankle instability severity. The CAIT consists of 9 items each containing choices ranging from 1 to 6, with scores from 0 to 5 for the right foot and left foot separately where the maximum score is 30 indicating high functional ankle stability while the minimum score is 0 indicating severe functional ankle instability (Hiller et al., 2006).
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start24 May 2024
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Factorial
- Model description
- Phase 1:Observational study. Phase 2: Double-blinded randomized control trial study. An explanation of the procedure and a written consent form will be provided. Then the CAIT will be used followed by assigning the participants into a healthy group and an injured group for the observational part and collecting the data on the injured foot. Then further randomly divided the injured group into a rigid taping group, a sham taping group, and a control group. Application of the interventions will be done to the affected foot and sham tape will be applied to the control group then the effects will be observed and the measurements will be noted and compared to the previous data. The CAIT will be used again to observe the differences that may result. The study will take place at Mousawat Institution.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499935
- Sponsor's protocol ID
- Taping on Foot Pressure
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Rigid Taping Versus Kinesio-Taping on Plantar Pressure Distribution in Basketball Players With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06499935
- Acronym / sponsor ID
- Taping on Foot Pressure
- Conditions
- Ankle Injuries, Ankle Injuries and Disorders, Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 15 Jul 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.
The goal of this study is to investigate whether there exists a difference in baropdometric readings of plantar pressure between individuals with chronic ankle instability and normal health individuals, in addition another goal of this study is to investigate the effect of rigid taping vs. kinesio taping on plantar pressure distribution as well as stability markers in individuals with chronic ankle instability.
The main questions aimed to answer are:
- Is there a difference in plantar pressure distribution between individuals with chronic ankle instability and individuals without chronic ankle instability?
- What effect do rigid and kinesio taping have on plantar pressure distribution and ankle stability markers?
- Which tape affects plantar pressure distribution and ankle stability better?
Participants will:
Firstly be divided into two macro groups, one with chronic ankle instability and one without, with an observational part of the study to be carried out to investigate the differences in plantar pressure between both groups.
Secondly, the group with chronic ankle instability will be divided into two micro groups one receiving rigid taping and the other receiving kinesio taping, and the immediate effects of these tapes in terms of plantar pressure and ankle stability will be recorded and compared before and after within groups, and after between both groups.
Detailed description
Basketball players frequently suffer from lateral ankle sprains and multiple repetitions can cause chronic ankle instability. The authors contend that professional basketball can no longer be regarded as a noncontact sport because of the rising rate of injuries to players in the league. An orthopedic strapping treatment for the foot called rigid taping involves applying tape along the plantar part of the foot and inferior to the malleoli.
Another type of taping method gives the musculoskeletal system external support, kinesio-taping has long been employed in the rehabilitation and prevention of sports-related injuries in athletes and sports participants. The goal of an anti-pronation taping technique is to constrain an overpronated foot by offering temporary external support.
Thus the aim of this study is to determine the immediate effects of rigid taping versus kinesio-taping on static and dynamic plantar pressure distribution in basketball players with chronic ankle instability. An explanation of the procedure and a written consent form will be provided, and the assessment will be taken at the beginning of the spring semester of 2024/2025 for inclusion and exclusion. Then the CAIT will be used followed by assigning the participants into a healthy group and an injured group for the observational part and collecting the data on the injured foot. Then further randomly divided the injured group into AP, LD, and a control group. Application of the interventions will be done to the affected foot and sham tape will be applied to the control group then the effects will be observed and the measurements will be noted and compared to the previous data. The CAIT will be used again to observe the differences that may result. The study will take place at Mousawat Institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 1:Observational study. Phase 2: Double-blinded randomized control trial study. An explanation of the procedure and a written consent form will be provided. Then the CAIT will be used followed by assigning the participants into a healthy group and an injured group for the observational part and collecting the data on the injured foot. Then further randomly divided the injured group into a rigid taping group, a sham taping group, and a control group. Application of the interventions will be done to the affected foot and sham tape will be applied to the control group then the effects will be observed and the measurements will be noted and compared to the previous data. The CAIT will be used again to observe the differences that may result. The study will take place at Mousawat Institution.
| Arm | Type | Receives |
|---|---|---|
| Rigid Taping Group | Experimental | Other: Rigid TapingA single application of tape will be fastened to the fibula's lateral malleolus, extended beneath the foot, and crossed the medial foot at the calcaneus and navicular tuberosity. After that, it will wrapped around the fibular and tibial shafts and passed across the anterior part of the ankle. The tape will be applied similarly to the other application, with 1.5 inches of overlap between the strips. |
| Kinesio Taping Group | Experimental | Other: Kinesio-TapingElastic kinesiology tape will be employed in this investigation. Patients will be comfortably positioned on a table raised sufficiently so that their feet couldn't contact the ground. At the hindfoot, a 2-inch, 25-centimeter strip will be applied, stretching it seventy-five percent from the middle third of the medial tibia to the fibula (lateral malleolus), around the calcaneus. Applying the strip in the maximally supinated position while going in the direction mentioned will allow the foot to eventually reach its maximum dorsal flexion. The interior aspect of the tibial bone and fibula will then wrapped |
| Sham Taping Group | Sham comparator | Other: Sham TapingThere are two steps to Sham taping: The internal malleolus is the starting point of the first stage, which extends to the lower limb's inner middle point. The second stage starts at the external malleolus and extends to the lower limb's outer middle point. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A history of at least 1 significant ankle sprain
- The initial sprain must have occurred at least 12 months before study enrollment
- A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
- Cumberland Ankle Instability Tool: score of 24 or less
Key exclusion criteria (3 listed)
- A history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either lower extremity
- A history of a fracture in either lower extremity requiring realignment
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (i.e., sprains, fracture) resulting in at least 1 interrupted day of desired physical activity.
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 |
|---|---|---|
| Rigid TapingIt is usually light brown or beige and is designed to hold firm, making it ideal for providing support or stability to a joint. | Other | Rigid Taping Group |
| Kinesio-TapingKinesio Taping Method is a therapeutic tool utilised by rehabilitation specialists in all programs. Kinesio Taping Method utilises four types of Kinesio Tex Tapes, each with specific properties designed for use on fragile, sensitive skin or applied with higher tensions. | Other | Kinesio Taping Group |
| Sham TapingSham taping is the use of any type of tape in a random and ineffective fashion for the purposes of comparison with other taping techniques and types. | Other | Sham Taping Group |
Primary outcome
Baropodometric measurements of plantar pressure distribution.
Time frame: immediately after the intervention
The plantar pressure data will be measured during single-leg stance and natural walk using the Gaitview (®) AFA-50 system (alFOOTs, Seoul, Republic of Korea). The pressure platform included a 410 × 410 × 3 mm active area consisting of a 45-mm thick floor mat (700 × 500 mm), comprising 2,304 (48 × 48) force-sensitive resistor sensors and sampling data at 17 Hz (Kim et al., 2012). An investigation of the reliability of the Gaitview® system using the two-step gait-initiation method was done. It demonstrated good to moderate reliability for measuring plantar pressure, and that it is suitable for use in clinical and research trials (Kim et al., 2012). Data will be recorded and saved using the same device.
1 secondary outcome
Ankle Stability
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid Taping and Kinesio-Taping in people with Ankle Injuries and Ankle Injuries and Disorders, run by Cairo University at 1 site in Lebanon.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baropodometric measurements of plantar pressure distribution. (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2024.