NCT04583059

Brief Summary

Leg length was measured (right and left leg) while the participant lying supine, from the anterior superior iliac spine to the inferior border of the ipsilateral medial malleoli by using standard measure tape. The dominant leg was determined according to Vauhnik. \& ark. modified version. The limb that was used in at least 2 of the 3 following activities: (1). Kicking a ball, (2). Drawing a diamond figure on the ground and (3).using his leg and step over a spider toy was considered as the dominant leg.30

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

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

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 4, 2020

Last Update Submit

October 8, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Balance

    Star Excursion Balance Test used to evaluate balance. Participant was asked to wear sport without shoes, then to step on the center of the grid by the dominant leg, plantar aspect of the first metatarsophalangeal joint was positioned at the center of the grid. Participant starts reaching as possible as far in the eight lines, make a light touch on the line, and return reaching leg back to center, while maintaining a single-leg stance with other leg at the grid center, starting from anterior direction, progressing clockwise. The order of the reaches as follows: A (anterior), AM (anteromedial), M (medial), PM (posteromedial), P (posterior), PL (posterolateral), L (lateral), AL (anterolateral). During the lateral and posterolateral directions, participants must reach behind the stance leg to complete task. These measurements were done 4 times, (before ankle taping, after 20 minutes while using ankle taping, after 24 hours while using ankle taping and immediately after removing the tap

    2 Months

  • Proprioception

    First step: volunteers seated in a high chair, while their eyes are closed, the researcher consecutively on different graduated surfaces (10° dorsiflexion, neutral position, 10° plantarflexion, 20° plantarflexion) each position was done for one time and held for 5 seconds. Researcher told volunteers that they have to memorize the positions to do it again themselves. Each position recorded to obtain the target angle using the universal goniometer. Second step: Volunteer encouraged to walk freely next to the researcher for 10 minutes, still blindfolded. Third step: volunteer sat on a high chair that did not allow his or her feet to touch the floor. Finally, the researcher encouraged the subject to reproduce the four memorized positions. Volunteer maintained each ankle position, announced by the researcher at random, for five seconds. These measurement were done four times (before, after 20 minutes, after 24 hours of using external support and immediately after removing external support

    2 Months

Study Arms (2)

Taping Group

EXPERIMENTAL

A hard-preventive Zinc oxide tape was used in this study. Taping procedure consists of three separate steps: First step involved application of the anchor tape, which achieved by applying the tape circumferentially just above the malleolar level at the lower end of the shank. Second step involved application of the stirrup. During this step, the foot was held in neutral, and the tape applied to pass from the medial side of the ankle, under the foot just over the heel area (posterior one-third of the foot) and up along the lateral side of the ankle. The second step was repeated to apply the second stirrup. Both ends of the stirrups were firmly attached to the anchor tape applied during the first step and this attachment was reinforced with a locking tape during the third and final step by once again applying the tape circumferentially just above the malleolar level at the lower end of the shank. Taping was applied by a physical therapist according to the health association requirements

Other: Taping

Bandaging Group

EXPERIMENTAL

Standard 10 cm width elastic bandage was used. The elastic bandage was wrapped around the ankle joint to form an 8-figure shape starting from the forefoot. Then, the bandage was taken diagonally upwards, steeply enough to go well above the heel. Then, the bandage was taken around the lower calf area to form an anchor. Then its diagonally taken down across the midfoot. Again the bandage was wrapped around the forefoot and going diagonally up to finish off around the lower calf, leaving the heel open. During the bandage application process, the therapiest didn't stretch the bandage, because bandage does note need to be stretched during the application, as the bandage becomes naturally tight when its layers wraped over each others. the participant was asked to wear his/her sport shoes over the bandage during the measurement procedures.

Other: Taping

Interventions

TapingOTHER

A hard-preventive Zinc oxide tape was used in this study. Taping procedure consists of three separate steps: First step involved application of the anchor tape, which achieved by applying the tape circumferentially just above the malleolar level at the lo

Bandaging GroupTaping Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-athletes

You may not qualify if:

  • Previous hip/pelvis, knee, ankle, or foot surgery within the past year
  • Lower extremity amputation
  • Injury to the lower extremities six months
  • Known balance impairment due to neurological disorder, vestibular disorder, medication use, or other
  • Pregnancy
  • Concussion within the previous three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motaz Alawna

Istanbul, 3, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Principal Investigator)

Study Record Dates

First Submitted

October 4, 2020

First Posted

October 12, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations