Manual Therapy After Ankle/Hindfoot Fractures
Condition: Ankle Fracture; Calcaneus Fracture; Talus Fracture; Pilon Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

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.
    

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.
    

Intervention name(s): Manual Therapy Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): The manual therapy intervention will be based on the typed of fracture the patient sustained, and their limitations in joint mobility.; The sham intervention will consist of soft tissue mobilization and Grade I mobilization at the proximal tib/fib joint.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual Therapy; Ankle Fracture; Hindfoot Fracture