NCT06499935

Brief 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. kinesio taping on plantar pressure distribution as well as stability markers in individuals with chronic ankle instability. The main questions aimed to answer are:

  1. 1.Is there a difference in plantar pressure distribution between individuals with chronic ankle instability and individuals without chronic ankle instability?
  2. 2.What effect do rigid and kinesio taping have on plantar pressure distribution and ankle stability markers?
  3. 3.Which tape affects plantar pressure distribution and ankle stability better?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 24, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 29, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

June 29, 2024

Last Update Submit

July 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately after the intervention

Secondary Outcomes (1)

  • Ankle Stability

    immediately after the intervention

Study Arms (3)

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.

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

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.

Other: Sham Taping

Interventions

It is usually light brown or beige and is designed to hold firm, making it ideal for providing support or stability to a joint.

Rigid Taping Group

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.

Kinesio Taping Group

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.

Sham Taping Group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed M. El Melhat

Beirut, 0000, Lebanon

RECRUITING

MeSH Terms

Conditions

Ankle InjuriesDisease

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 15, 2024

Study Start

May 24, 2024

Primary Completion

September 25, 2024

Study Completion

October 25, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations