NCT02244008

Brief Summary

The purpose of this study is to verify the effect of anteroposterior talus mobilization on range of motion, pain, and functional capacity in participants with sub-acute and chronic ankle injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

1.4 years

First QC Date

September 15, 2014

Last Update Submit

September 16, 2014

Conditions

Keywords

MobilizationJoint Range of MotionAnkleManual Therapy

Outcome Measures

Primary Outcomes (1)

  • Changes in dorsiflexion range of motion

    Dorsiflexion range of motion were measured by biplane goniometer.

    1 month

Secondary Outcomes (2)

  • Changes in pain intensity

    1 month

  • Changes in functional capacity

    1 month

Study Arms (2)

joint mobilization

EXPERIMENTAL

Anteroposterior mobilization of the talus (Maitland mobilization grade III)

Other: joint mobilization

manual contact

PLACEBO COMPARATOR
Other: manual contact

Interventions

The experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.

joint mobilization

The placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.

manual contact

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • unilateral traumatic injury of the ankle with at least two weeks and maximum eight months
  • at least a 5º limitation of passive dorsiflexion in comparison to the contralateral side
  • do not be under another physical therapy treatment for the lesion
  • able to unload partial or total body weight
  • do not be in use of analgesic
  • provided informed consent after receiving and explanation of all procedures and pertinent information regarding the study

You may not qualify if:

  • joint blockage by surgical fixation or ankylosis
  • presence of vascular, rheumatic, neurological and neoplastic disease in the lower limb
  • open or contagious lesion in the ankle region
  • pain during palpation in the region anterior of the ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minas Gerais College of Medical Sciences

Belo Horizonte, Minas Gerais, 30130-110, Brazil

Location

Related Publications (5)

  • Hoch MC, Andreatta RD, Mullineaux DR, English RA, Medina McKeon JM, Mattacola CG, McKeon PO. Two-week joint mobilization intervention improves self-reported function, range of motion, and dynamic balance in those with chronic ankle instability. J Orthop Res. 2012 Nov;30(11):1798-804. doi: 10.1002/jor.22150. Epub 2012 May 18.

  • Landrum EL, Kelln CB, Parente WR, Ingersoll CD, Hertel J. Immediate Effects of Anterior-to-Posterior Talocrural Joint Mobilization after Prolonged Ankle Immobilization: A Preliminary Study. J Man Manip Ther. 2008;16(2):100-5. doi: 10.1179/106698108790818413.

  • Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.

  • Hoch MC, McKeon PO. Joint mobilization improves spatiotemporal postural control and range of motion in those with chronic ankle instability. J Orthop Res. 2011 Mar;29(3):326-32. doi: 10.1002/jor.21256. Epub 2010 Sep 30.

  • Harkey M, McLeod M, Van Scoit A, Terada M, Tevald M, Gribble P, Pietrosimone B. The immediate effects of an anterior-to-posterior talar mobilization on neural excitability, dorsiflexion range of motion, and dynamic balance in patients with chronic ankle instability. J Sport Rehabil. 2014 Nov;23(4):351-9. doi: 10.1123/jsr.2013-0085. Epub 2014 Apr 3.

MeSH Terms

Conditions

Ankle InjuriesAnkle Fractures

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesFractures, Bone

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
Master

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 18, 2014

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations