NCT04377269

Brief Summary

Objective: This study aimed to 1) investigate the long-term effect of taping and bandaging on proprioception, balance, and vertical jump among volleyball players with ankle instability, 2) Compare the short-term effects of taping and bandaging on these outcome measures, 3) Compare the long-term effects of taping and bandaging on these outcome measures. Design: A single-blinded randomized controlled study Setting: Rehabilitation Laboratory at Istanbul Gelisim University, Turkey Subjects: One-hundred participants with a chronic ankle sprain (CAI) Primary outcome measures: Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester) Interventions: Participants were distributed into three groups: taping group (n=33) received ankle rigid taping, bandaging group (n=33) received ankle bandaging, and control group (n=34) received placebo taping. All three previous external supports were applied for 8 weeks. The measurements were performed at baseline, immediately after applying for support, two weeks after support and eight months after support.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

2.7 years

First QC Date

May 2, 2020

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Proprioception

    Measure the Range of motion Standard error at three different range of motion angles (10° dorsiflexion, neutral position, 10° plantarflexion, and 20° plantarflexion).

    2 Months

  • Balance

    The Y-Balance test was used to evaluate balance.

    2 Months

  • Vertical Jump Distance

    The vertical jump tester (Sports Imports, Columbus, OH)

    2 Months

Study Arms (3)

Taping Group

EXPERIMENTAL

33 participants, received ankle taping

Other: Taping and Bandaging

Bandaging

EXPERIMENTAL

33 participants, received ankle bandaging

Other: Taping and Bandaging

Placebo Taping (Control) Group

PLACEBO COMPARATOR

34 participants, received ankle placebo taping

Other: Taping and Bandaging

Interventions

Ankle taping: a hard preventive Zinc oxide tape was used. The taping procedures consisted of three separate steps. 1) included the application of the anchor tape. 2) application of the stirrup tape. The stirrup tape was performed two times by holding the foot in a neutral position and the tape is placed as it passed through 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. Bandaging: standard 10cm width elastic bandage used. The bandage wrapped around the ankle joint in the form of an 8-figure. Bandage started from the forefoot, moving diagonally upwards and steeply enough to go well above the heel to end around the lower calf area to form an anchor. Then, it moved diagonally down across the mid-foot. Placebo: 10cm long tape was applied on the lateral side of the leg, just above the lateral malleolus and aligned with peroneus longus tendon

BandagingPlacebo Taping (Control) GroupTaping Group

Eligibility Criteria

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

You may qualify if:

  • Volleyball Player
  • years old
  • Athletes with chronic ankle instability

You may not qualify if:

  • Previous hip/pelvis knee, or foot surgery within the past year
  • Leg length discrepancies
  • Known balance impairment due to neurological disorder
  • Vestibular disorder
  • Pregnancy
  • Brain concussion within the previous three months
  • Taking any medication that may affect alertness or balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 6, 2020

Study Start

January 1, 2017

Primary Completion

October 1, 2019

Study Completion

January 1, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share