Clinical trial NCT02609347: Manual Therapy After Ankle/Hindfoot Fractures
Official title: Immediate Effects of Manual Therapy for Patients After Ankle/Hindfoot Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture
Calcaneus Fracture
Talus Fracture
Pilon Fracture
Keywords: Manual Therapy
Ankle Fracture
Hindfoot Fracture
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2015-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Range of motion (ROM)
timeFrame: 2 weeks
measure: Spatial and temporal gait parameters - gait velocity
timeFrame: 2 weeks
measure: Balance
timeFrame: 2 weeks
Secondary outcomes:
measure: Characteristics that predict outcomes
timeFrame: 2 weeks
measure: Foot Mobility - Foot Assessment Platform (FAP)
timeFrame: 2 weeks
measure: Muscle Stiffness - MyotonPRO Device
timeFrame: 2 weeks
measure: Stance Time
timeFrame: 2 weeks
measure: Single Limb Stance Time
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
affiliation: Intermountain Health Care
name: Stephanie R Albin, DPT, FAAOMPT
role: PRINCIPAL_INVESTIGATOR
References:
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