NCT01438905

Brief Summary

The purpose of this study is to examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

September 14, 2011

Last Update Submit

February 22, 2018

Conditions

Keywords

Ankle SprainChronic Ankle InstabilityAnkle MobilizationTalocrural Joint MobilizationCortical Muscle ActivationSpinal Muscle Activation

Outcome Measures

Primary Outcomes (3)

  • Changes in Muscle activation

    To determine cortical and spinal changes in muscle activation of the fibularis longus and soleus following one of three intervention protocols. Changes in cortical and spinal muscle activation will be measured by examining resting motor threshold via Transcranial Magnetic Stimulation and the H-reflex technique, respectively. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in a greater increase in cortical and spinal activation of the fibularis longus and soleus muscles than the lower intensity talocrural joint mobilization.

    Baseline and immediately after each manual therapy intervention; 1 week study

  • Changes in Ankle dorsiflexion ROM

    To determine the changes in ankle dorsiflexion ROM following one of two talocrural joint mobilization techniques (higher or lower intensity) or control intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge. The investigators hypothesize that the higher intensity (Grade V) talocrural joint mobilization will result in a greater improvement in ankle dorsiflexion ROM than the lower intensity (Grade IV) talocrural joint mobilization and the control intervention will result in no change in ROM.

    Baseline and immediately after each manual therapy intervention; 1 week study

  • Changes in Dynamic Balance

    To determine the acute changes in balance following one of two talocrural joint mobilization techniques or control intervention in individuals with CAI. Changes in balance will be quantified using the anterior, posteromedial, and posterolateral components of the Star Excursion Balance Test. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in greater improvements in reach distance in all three SEBT directions compared to the lower intensity talocrural joint mobilization.

    Baseline and immediately after each manual therapy intervention; 1 week study

Study Arms (3)

Control

NO INTERVENTION

Parameters will be identical to the lower intensity (Small amplitude oscillation mobilization; Grade IV) talocrural mobilization. No force, other than light hand contact will be applied by the therapist.

Lower intensity mobilization

EXPERIMENTAL

The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.

Other: Small amplitude (Grade IV) mobilization

Higher intensity mobilization

EXPERIMENTAL

The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.

Other: High velocity, low amplitude (Grade V) mobilization

Interventions

The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.

Lower intensity mobilization

The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.

Also known as: Manipulation, Grade V mobilization, High velocity, low amplitude thrust
Higher intensity mobilization

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 16-45 years
  • History of one or more ankle sprains
  • Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
  • At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°

You may not qualify if:

  • Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
  • Diagnosed ankle osteoarthritis
  • History of ankle surgery that involves intra-articular fixation
  • Medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Related Publications (1)

  • Grindstaff TL, Dolan N, Morton SK. Ankle dorsiflexion range of motion influences Lateral Step Down Test scores in individuals with chronic ankle instability. Phys Ther Sport. 2017 Jan;23:75-81. doi: 10.1016/j.ptsp.2016.07.008. Epub 2016 Jul 29.

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Terry L Grindstaff, PhD, PT, ATC

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations