NCT03079804

Brief Summary

The ankle joint is often affected by injuries, especially lateral sprains, often leading to chronic instability. Joint mobilization techniques seem to influence the sense of joint positioning. The objective of the study is to compare mobilization techniques in the balance of athletes with chronic ankle instability. A randomized clinical trial with participants allocated in three groups: Talocrural manipulation, mobilization with movement and placebo will be assessed in their primary endpoints and secondary balance and dorsiflexion range of motion respectively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 30, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 6, 2017

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Balance assessed with Biodex Balance System

    Balance assessed with Biodex Balance System (stabilometry plattaform)

    almost 10 minutes

Study Arms (3)

Experimental MWM

EXPERIMENTAL

Other names: 4 mobilizations - 10 seconds 20 seconds of rest

Other: Experimental MWMOther: Experimental ThrustOther: Placebo

Experimental Thrust

ACTIVE COMPARATOR

Other names: 1 traction with caudal direction in high speed and low amplitude increasing dorsiflexion.

Other: Experimental MWMOther: Experimental ThrustOther: Placebo

Placebo

PLACEBO COMPARATOR

Other names: It will accurately reproduce the positioning of the hand in the specific treatment condition (Thrust or MWM), however, without applying any movement or force. All interactions, procedures and deadlines will be identical.

Other: Experimental MWMOther: Experimental ThrustOther: Placebo

Interventions

Mobilization with Movement

Experimental MWMExperimental ThrustPlacebo

Mobilization grade 5 (Thrust)

Experimental MWMExperimental ThrustPlacebo
PlaceboOTHER

Procedures similar to Experimental MWM group, but without aplly any force

Experimental MWMExperimental ThrustPlacebo

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be a regular practitioner of some sporting modality (with a minimum of one year of practice and training frequency of twice a week), with a history of at least one unilateral ankle sprain with episodes of pain and decreased function, as well as a subjective report of Ankle instability (sensation of falsehood) after ligament injury associated with a result lower than 24 points in the Portuguese version of the Cumberland Ankle Instability Tool - CAIT

You may not qualify if:

  • Participants with acute or subacute lesions and / or lower limb surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Ceará

Fortaleza, Ceará, 60416130, Brazil

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Pedro Lima, PhD

    UFC - DEFISIO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Lima, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Opaque envelopes
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Physical Therapy

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 14, 2017

Study Start

January 30, 2017

Primary Completion

April 30, 2018

Study Completion

December 31, 2018

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations