NCT01618032

Brief Summary

Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. However, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability. The aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

June 8, 2012

Last Update Submit

November 30, 2012

Conditions

Outcome Measures

Primary Outcomes (5)

  • Pre-intervention ankle dorsiflexion

    Ankle dorsiflexion is measured by the weight-bearing lunge method

    pre-intervention

  • Inmediately post-intervention ankle dorsiflexion

    Ankle dorsiflexion is measured by the weight-bearing lunge method

    inmediately post-intervention

  • ten minutes post-intervention ankle dorsiflexion

    Ankle dorsiflexion is measured by the weight-bearing lunge method

    ten minutes post-intervention

  • 24 hr post-intervention ankle dorsiflexion

    Ankle dorsiflexion is measured by the weight-bearing lunge method

    24 hr post-intervention

  • 48 hr post-intervention ankle dorsiflexion

    Ankle dorsiflexion is measured by the weight-bearing lunge method

    48 hr post-intervention

Study Arms (3)

HVLA

EXPERIMENTAL

High velocity and low amplitude traction manipulation on the ankle joint

Other: HVLA

MWM

EXPERIMENTAL

Mobilization with movement on ankle joint as Mulligan

Other: MWM

placebo

SHAM COMPARATOR

Contact without therapeutic effect

Other: placebo

Interventions

HVLAOTHER

High velocity and low amplitude manipulation in traction of subtalar jonit

HVLA
MWMOTHER

Mobilization with movement as Mulligan for increase dorsiflexion of the ankle in weight bearing

MWM
placeboOTHER

Manual contact during a period of time similar of teh other interventions

placebo

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects with chronic ankle instability

You may not qualify if:

  • Acute or subacute ankle sprain.
  • Recent lesions in lower extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ángel L Rodríguez-Fernández, PT, MSc

    CEU San Pablo University

    PRINCIPAL INVESTIGATOR
  • David Marrón-Gómez, PT, MSc

    CEU San Pablo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at Physical Therapy Department

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 13, 2012

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

November 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11