NCT01733433

Brief Summary

The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. Subjects with CAI will perform these exercises with and without tape. Hypothesis is that subjects with CAI that tape will enhance postural control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration 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

First Submitted

Initial submission to the registry

November 13, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

November 13, 2012

Last Update Submit

November 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Immediate postural control with tape on ankle.

    Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics.

    for 75 minutes, the duration of the exercises.

Secondary Outcomes (3)

  • Subjective evaluation of the effect of taping on pain

    1 minute after the exercises (which last approximately 75 minutes).

  • Subjective evaluation of the effect of taping on difficulty level.

    1 minute after the exercises (which last approximately 75 minutes).

  • Subject evaluation of the effect of taping on instability feelings.

    1 minute after the exercises (which last approximately 75 minutes).

Study Arms (1)

taped ankle

EXPERIMENTAL

Subjects will be taped in at the ankle for a series of exercises.

Procedure: Taping the ankle

Interventions

Subjects will be taped in at the ankle for performing several exercises.

taped ankle

Eligibility Criteria

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

You may qualify if:

  • a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks
  • repeated ankle sprains
  • presence of giving way
  • feeling of weakness around the ankle
  • a decreased functional participation (recreational, competitive or professionally)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Study Officials

  • Philip Roosen, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 27, 2012

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations