Manual Therapy After Ankle/Hindfoot Fractures

March 12, 2019 updated by: Stephanie Albin, Intermountain Health Care, Inc.

Immediate Effects of Manual Therapy for Patients After Ankle/Hindfoot Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will enroll 76 subjects with stiffness after ankle and/or hindfoot fractures. Stiffness will be defined in this study with the ankle lunge test. This test measures dorsiflexion (DF) in a weight bearing position, and a side-to-side difference of > 5.0 centimeters (cm) will be used for the criteria to determine ankle stiffness as this is greater than three times the smallest real difference of 1.38 cm. Potential subjects will be recruited by either their orthopedic surgeon or the PI and must satisfy all inclusion/exclusion criteria. Those individuals meeting the eligibility criteria who agree to participate and sign an informed consent from the appropriate Internal Review Board (IRB) will undergo a baseline assessment. The baseline assessment will be performed by a clinician blinded to the subject's treatment group assignment. Participants will be randomized to receive manual therapy (MT) or to the control group (CONTROL) based on a list generated by a computer program and sequentially numbered and placed in a sealed envelope after baseline measures are completed. Participants will then be given a chance to practice the functional tests prior to the baseline assessment, and will have a chance to rest if needed. The order in which tests are administered will be randomized by a computer generated process. Participants will be asked to perform the following tests: single limb stance (average of 3 trials), the Star excursion balance test (anterior, posteromedial, and posterolateral directions only) (average of 3 trials), the ankle lunge test (ALT), the foot assessment platform, the MyotonPRO and walk across the GAITRite mat. Patients will perform all tests without shoes in order to standardize footwear between subjects, and all tests will be performed on both the affected and unaffected sides.

After all baseline measures have been taken, participants will be randomized to either the MT or the Control Group. Participants in the manual therapy group will receive joint mobilization and 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. Treatment for the manual therapy group will be based on the physical therapist's clinical decision making that is fellowship trained in manual therapy. For instance, if a patient has a talar neck fracture and is lacking dorsiflexion, the therapist may choose to avoid an anterior-posterior talocrural joint mobilization which may place increased stress through the talar neck and mobilize instead the talonavicular joint and/or the subtalar joint based on stiffness.

After receiving treatment, participants will again perform the tests and measures in a random order, and will be allowed to rest as much as needed. The amount of time needed to rest between tests will be documented. Participants will return for 2 additional follow up visits between 7 to 10 days after the initial examination and measurements; however, they will only be asked to fill out the self-reported questionnaires and perform the tests and measures after the second treatment. Participants will then follow up between 7-10 days after their last manual therapy treatment for a final measurement of all tests and measures. Participants in the control group will be asked to follow-up at the same time points as the manual therapy group after their initial baseline measures and asked to complete all questionnaires and tests at the same time points as the manual therapy group. Subjects will be asked to avoid practicing balance and beginning exercises other than normal activities of daily living during this time.

Specific Aim 1: To evaluate if manual therapy improves range of motion, muscle stiffness, and in patients with ankle stiffness after ankle/hindfoot fractures more than a control group.

The dependent variables for Aim1 are weight bearing dorsiflexion range of motion (ROM), foot mobility, and muscle stiffness. The independent variables for Aim1 are treatment group (MT vs CONTROL) and time. The primary aim will be examined using a linear mixed model with repeated measures to account for the correlation among repeated observations from the same patient. Time (baseline, assessment 1 and assessment 2) and treatment group (MT and CONTROL) will be modeled as fixed effects, with the ALT as the primary dependent variable (DV). Separate models will be constructed in a similar fashion with foot mobility magnitude (FMM) and muscle stiffness as the DV. The hypothesis of interest will be the group-by-time interaction. Treatment effects will be calculated from the between-group differences in change score from baseline to assessment 1 and assessment 2.

Specific Aim 2: To evaluate if patients receiving three manual therapy treatments will have greater improvements in spatial and temporal gait parameters than a control group.

The dependent variables for Aim 2 are gait velocity and stance times. The independent variables for Aim 2 are treatment group (MT vs CONTROL) and time. The primary aim will be examined using a linear mixed model with repeated measures to account for the correlation among repeated observations from the same patient. Time (baseline, assessment 1 and assessment 2) and treatment group (MT and CONTROL) will be modeled as fixed effects, with gait velocity as the primary dependent variable (DV). A separate model will be constructed in a similar fashion with stance time as the DV. The hypothesis of interest will be the group-by-time interaction. Treatment effects will be calculated from the between-group differences in change score from baseline to assessment 1 and assessment 2.

Specific Aim 3: To evaluate if patients receiving three manual therapy treatments will have greater improvement in balance than a control group.

The dependent variables for Aim3 are distances reached on the star excursion balance test and single limb stance times. The independent variables for Aim3 are treatment group (MT vs CONTROL) and time. The primary aim will be examined using a linear mixed model with repeated measures to account for the correlation among repeated observations from the same patient. Time (baseline, assessment 1 and assessment 2) and treatment group (MT and Control) will be modeled as fixed effects, with distance reached for the star excursion balance test (SEBT) as the primary dependent variable (DV). A separate model will be constructed in a similar fashion with single limb stance time as the DV. The hypothesis of interest will be the group-by-time interaction. Treatment effects will be calculated from the between-group differences in change score from baseline to assessment 1 and assessment 2.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84118
        • Intermountain Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manual Therapy Group
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
The manual therapy intervention will be based on the typed of fracture the patient sustained, and their limitations in joint mobility.
SHAM_COMPARATOR: Control Group
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
The sham intervention will consist of soft tissue mobilization and Grade I mobilization at the proximal tib/fib joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (ROM)
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics that predict outcomes
Time Frame: 2 weeks
Multiple linear regression analysis will be performed to determine if baseline characteristics such as fracture type, age, etc can predict changes in biomechanical outcomes
2 weeks
Foot Mobility - Foot Assessment Platform (FAP)
Time Frame: 2 weeks
The dependent variable is foot mobility. The independent variables are treatment group (Manual therapy group versus Control group) and time. Foot mobility will be assessed using the FAP.
2 weeks
Muscle Stiffness - MyotonPRO Device
Time Frame: 2 weeks
The dependent variable is muscle stiffness. The independent variables are group and time. Muscles stiffness will be assessed using the MyotonPRO device.
2 weeks
Stance Time
Time Frame: 2 weeks
The dependent variable is stance time. The independent variables are group and time.
2 weeks
Single Limb Stance Time
Time Frame: 2 weeks
The dependent variable is single limb stance time. The independent variables are treatment group (Manual therapy group versus Control group) and time.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Collaborators

University of Utah

Investigators

  • Principal Investigator: Stephanie R Albin, DPT, FAAOMPT, Intermountain Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (ESTIMATE)

November 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1050061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planning on sharing data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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