Manual Therapy After Ankle/Hindfoot Fractures

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.

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