NCT02609347

Brief Summary

The aim of this randomized controlled trial is to assess if manual therapy improves mobility, gait, and balance more than a control group for patients who have undergone open reduction internal fixation (ORIF) after an ankle/hindfoot fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3.3 years

First QC Date

October 29, 2015

Last Update Submit

March 12, 2019

Conditions

Ankle FractureCalcaneus FractureTalus FracturePilon Fracture

Keywords

Manual TherapyAnkle FractureHindfoot Fracture

Outcome Measures

Primary Outcomes (3)

  • Range of motion (ROM)

    The dependent variable for Aim1 is weight bearing dorsiflexion ROM. The independent variables for Aim1 are treatment group (Manual therapy group versus Control group) and time

    2 weeks

  • Spatial and temporal gait parameters - gait velocity

    The dependent variable for Aim 2 is gait velocity. The independent variables for Aim 2 are treatment group (Manual therapy group versus Control group) and time.

    2 weeks

  • Balance

    The dependent variables for Aim3 is distances reached on the star excursion balance test. The independent variables for Aim3 are treatment group (Manual therapy group versus Control group) and time.

    2 weeks

Secondary Outcomes (5)

  • Characteristics that predict outcomes

    2 weeks

  • Foot Mobility - Foot Assessment Platform (FAP)

    2 weeks

  • Muscle Stiffness - MyotonPRO Device

    2 weeks

  • Stance Time

    2 weeks

  • Single Limb Stance Time

    2 weeks

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL

Participants in the manual therapy group will receive 3 treatment sessions of joint mobilization based on the physical therapist's clinical decision making.

Other: Manual Therapy Group

Control Group

SHAM COMPARATOR

Participants in the control group will receive a sham manual therapy treatment consisting of soft tissue mobilization and Grade I mobilizations at the proximal tib/fib joint.

Other: Control Group

Interventions

Manual Therapy GroupOTHER

The manual therapy intervention will be based on the typed of fracture the patient sustained, and their limitations in joint mobility.

Manual Therapy Group
Control GroupOTHER

The sham intervention will consist of soft tissue mobilization and Grade I mobilization at the proximal tib/fib joint.

Control Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Stiffness \> 5.0 cm side to side difference as measured by the ankle lunge test
  • Surgical management of ankle or hindfoot fracture
  • Full weight-bearing (WB)
  • Able to read and speak sufficient English to complete outcome tools

You may not qualify if:

  • Any prior foot/ankle surgery, deformity, or injury on the unaffected side which would affect gait, WB dorsiflexion or balance
  • Unable to attend follow-up visits
  • Any cognitive impairments which would prevents patients from being able to complete or understand questionnaires
  • Have received any previous manual therapy for their current ankle and/or hindfoot fracture
  • Have a known non/malunion
  • Have additional fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
  • Have avascular necrosis as demonstrated on radiographs
  • Syndesmotic screw intact
  • Open reduction internal fixation \>12 months previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Healthcare

Salt Lake City, Utah, 84118, United States

Location

Related Publications (10)

  • van Tetering EA, Buckley RE. Functional outcome (SF-36) of patients with displaced calcaneal fractures compared to SF-36 normative data. Foot Ankle Int. 2004 Oct;25(10):733-8. doi: 10.1177/107110070402501007.

    PMID: 15566705RESULT

  • Griffin D, Parsons N, Shaw E, Kulikov Y, Hutchinson C, Thorogood M, Lamb SE; UK Heel Fracture Trial Investigators. Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial. BMJ. 2014 Jul 24;349:g4483. doi: 10.1136/bmj.g4483.

    PMID: 25059747RESULT

  • Balazs GC, Polfer EM, Brelin AM, Gordon WT. High seas to high explosives: the evolution of calcaneus fracture management in the military. Mil Med. 2014 Nov;179(11):1228-35. doi: 10.7205/MILMED-D-14-00156.

    PMID: 25373046RESULT

  • Schulze W, Richter J, Russe O, Ingelfinger P, Muhr G. Surgical treatment of talus fractures: a retrospective study of 80 cases followed for 1-15 years. Acta Orthop Scand. 2002 Jun;73(3):344-51. doi: 10.1080/000164702320155374.

    PMID: 12143985RESULT

  • Hirschmuller A, Konstantinidis L, Baur H, Muller S, Mehlhorn A, Kontermann J, Grosse U, Sudkamp NP, Helwig P. Do changes in dynamic plantar pressure distribution, strength capacity and postural control after intra-articular calcaneal fracture correlate with clinical and radiological outcome? Injury. 2011 Oct;42(10):1135-43. doi: 10.1016/j.injury.2010.09.040. Epub 2010 Nov 13.

    PMID: 21075372RESULT

  • O'Brien J, Buckley R, McCormack R, Pate G, Leighton R, Petrie D, Galpin R. Personal gait satisfaction after displaced intraarticular calcaneal fractures: a 2-8 year followup. Foot Ankle Int. 2004 Sep;25(9):657-65. doi: 10.1177/107110070402500911.

    PMID: 15563389RESULT

  • Simondson D, Brock K, Cotton S. Reliability and smallest real difference of the ankle lunge test post ankle fracture. Man Ther. 2012 Feb;17(1):34-8. doi: 10.1016/j.math.2011.08.004. Epub 2011 Sep 29.

    PMID: 21959254RESULT

  • Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4.

    PMID: 22222143RESULT

  • Hertel J, Braham RA, Hale SA, Olmsted-Kramer LC. Simplifying the star excursion balance test: analyses of subjects with and without chronic ankle instability. J Orthop Sports Phys Ther. 2006 Mar;36(3):131-7. doi: 10.2519/jospt.2006.36.3.131.

    PMID: 16596889RESULT

  • McPoil TG, Vicenzino B, Cornwall MW, Collins N, Warren M. Reliability and normative values for the foot mobility magnitude: a composite measure of vertical and medial-lateral mobility of the midfoot. J Foot Ankle Res. 2009 Mar 6;2:6. doi: 10.1186/1757-1146-2-6.

    PMID: 19267907RESULT

MeSH Terms

Conditions

Ankle Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Stephanie R Albin, DPT, FAAOMPT

    Intermountain Health Care

    PRINCIPAL INVESTIGATOR

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
DPT, OCS, FAAOMPT

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Not planning on sharing data

Locations

US(1)