Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
Phase: NA
Conditions: Musculoskeletal Injury
Sponsor: Wake Forest University Health Sciences

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Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity 
Fractures: A randomized clinical trial 
 
Principal Investigator: Rachel Seymour, PhD 
Co-Principal Investigator: Michael Bosse, MD 
CMC Investigators: Joseph Hsu MD, Madhav Karunakar MD, Laurence Kempton MD, Stephen 
Sims MD, Meghan Wally MSPH, Christine Churchill MA, Richard Peindl PhD, Nahir Habet MS 
 
1. SCIENTIFIC AIMS 
The care of extremity trauma has evolved over the past 25 years. In the era of prolonged skeletal 
traction and/or casting following extremity trauma, the use of post-injury supervised physical 
therapy (PT) was required to achieve good outcomes. Seminal changes in the care of extremity 
trauma include early long bone fracture fixation and stable joint reconstruction. These techniques 
allow for immediate ambulation with assistive devices, early joint range of motion and major 
muscle group activation. However, evidence on the use of more efficient and cost effective 
rehabilitation methods has not evolved at the same pace. Consequently, post-injury, clinic-based 
PT is often uniformly included as a standard of care rehabilitation protocol for uncomplicated 
extremity fractures. No data exist to guide clinical decision making regarding the neccesity of 
this approach or to identify subgroups of patients who may be able to achieve similar outcomes 
using a standardized self-directed, home exercise program. The impact of a home-based PT 
program on clinically relevant outcomes following isolated and uncomplicated lower extremity 
fracture has never been evaluated.  
  
 
The purpose of this study is to compare the effectiveness and value of clinic-based PT and a 
home-based, self-directed exercise program (SDEP). The home exercise program will be 
developed by a team of physical therapists, orthopaedic trauma surgeons and experts in 
rehabilitation engagement in collabortion with patients recovering from traumatic lower-
extremity injuries. The study will also determine which subgroups of individuals based on 
patient and injury characteristics are the best candidates for a home exercise program.  
 
Hypothesis: The overall hypothesis is that return to work/major activities as well as clinical 
and functional outcomes and health-related quality of life for patients who receive clinic-
based PT will be similar to patients receiving SDEP. 
 
Specific Aim 1: To compare the effectiveness of SDEP, exercise instructions given by 
physician and clinic-based PT for improving return to work/major activities, clinical and 
functional/performance outcomes and health-related quality of life in patients following 
selected lower-extremity fractures. 
Specific Aim 2: To determine which sub-groups of patients, based on patient and injury 
characteristics, are most likely to benefit from SDEP. 
Specific Aim 3: To compare the cost-effectiveness of clinic-based PT and SDEP. 
 
2. BACKGROUND & SIGNIFICANCE  
There is little clinical debate that patients with multiple extremity injuries or injuries with 
associated complex soft tissue damage or nerve deficits benefit from supervised PT. Prior 

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research from the LEAP Study examined the impact of PT on patients with high energy trauma 
injuries below the distal femur.1 While the surgeons and PTs differed in their assessment of 
perceived need for PT,2,3 evidence demonstrates the beneficial effect of PT for this patient 
population.4 Research on combat-related lower extremity limb salvage patients showed a 
significant benefit and a higher return-to-duty rate following intense and focused rehabilitation 
combined with an integrated orthotic.5-7 However, the majority of lower extremity fractures seen 
in the military and civilan sectors are not combat related or of the severity of the LEAP limb 
salvage patients and, thus may not require intensive, clinic-based, supervised PT treatment. 
Patients with isolated major lower extremity fractures may benefit from a self-guided, home-
based post-injury exercise program. Studies evaluating home exercise programs for elective 
orthopaedic reconstruction surgery for joint replacement and ACL reconstruction have reported 
equivalent outcomes compared to in-person, supervised PT.8-12 Because PT resources are critical, 
limited, and expensive in most civilan centers, identifying the patients who would most benefit 
from utilizing these resources could result in savings for both the patients and the health care 
systems, and lead to more efficient access to PT services by the population who needs them the 
most. In addition to health systems benefits, patients able to achieve positive outcomes through a 
home-based, self-directed exercise program would experience flexibility regarding when the 
exercises are performed.  
 
PREVIOUS WORK DONE ON THE PROJECT 
This study builds on a growing body of data that indicate, following various elective and 
traumatic orthopaedic procedures, patients who are provided structured self-directed home-based 
rehabilitation can achieve similar outcomes to those who receive traditional clinic based 
rehabiliation services.12-23 Our institution recently completed an observational  study assessing 
the outcomes of patients with severe ankle fractures with and without dislocation.12 47% of the 
patients (those in community based practice) received post-operative in-person, supervised PT, 
whereas  53% of the patients (those from an academic medical center) received only a surgeon 
directed home-based exercise program. At 6 months post injury, physical function outcomes 
measured by the Short Musculoskeletal Function Assessment (SMFA)24  and Foot and Ankle 
Ability Measure (FAAM)25 were similar. These data suggest that a structured, home-based 
exercise program is acceptable to patients and surgeons and that this may be an effective 
rehabilitation approach for post-fixation lower extremity fractures for selected injuries and in 
selected patients.   
 
3. METHOD  
We are proposing a pilot of a multi-center, randomized controlled trial that will compare clinic-
based PT, self-directed, home exercise program (SDEP), and standard of care surgeon exercise 
instructions (SOC-SEI) in patients with selected lower-extremity fractures. Patients between the 
ages of 18-65 and with fractures of the femur or tibia treated with intramedullary fixation or 
with articular fractures of the distal femur (33A,B,C), proximal (41A,B,C) or distal tibia (43A, 
B,C) treated with plate fixation will be enrolled. Assessments will be conducted at baseline) and 
3, 6, and 12 months after hospital discharge. Patients will complete a battery of questionnaires 
measuring psychosocial factors, return to major activities/work, pain, and health-related quality 
of life as well as performance-based tests with electronically augmented kinematic data capture 
via the Mobility Toolkit at each assessment visit. Range of motion and strength will also be 

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assessed using goniometry and a stabilized hand-held force gauge, respectively. 
 
Inclusion criteria: Patients aged 18-65 with operative fractures of the femur and tibia (to 
include distal femur (33A, B), plateau (41A, B), pilon (43A, B), and selected ankle injuries 
(44A, B)) presenting to the Orthopaedic Surgeon for either acute care or for the follow-up of 
care performed elsewhere (within 14 days of the injury). All patients must be English or 
Spanish competent and able to be followed at the sites for at least 12 months following 
injury.  
Exclusion criteria:  Patients with ISS>18, bilateral lower-extremity injuries that preclude 
crutch ambulation, associated spine, pelvic, and/or acetabular fractures that otherwise alter 
weightbearing plans, type III B/C open fractures, Glasgow Coma Scale <15 at time of 
discharge, major peripheral nerve injury, or planned admission to a skilled nursing facility 
or inpatient rehabilitation facility, pregnant women, and patients diagnosed with a TBI will 
be excluded from the study.  
 
Comparators: Patients will be randomized to one of three groups –  
Insured patients 
• Clinic-based PT: Patients will be referred to PT by the orthopaedic surgeon for 
enrollment into a clinic-based PT program per usual referral patterns at the surgeon’s 
center. Patients will receive services based on their health care benefits defined by his 
or her insurance plan.  
• SDEP: The full SDEP program, which will be developed by physical therapists, 
orthopaedic trauma surgeons, and investigators with experience in health behavior 
change, will be designed to maximize adherence/compliance with the program. The 
SDEP manual will provide detailed instructions on exercises, such as repetitions, 
frequency, and required equipment, which can be implemented in the home 
environment. The basis for the exercise regimen is derived from the AAOS sample 
home based exercise program available in handout form, which can be found at 
http://orthoinfo.aaos.org/topic.cfm?topic=A00672. The program provides instructions 
on exercises, repetitions or duration, frequency, and required equipment which can be 
implemented in the home environment.  
Uninsured Patients 
Patient with no access to health insurance will be approached for the study and randomized 
to the full SDEP program or standard of care/surgeon exercise instructions ( SOC-SEI).  
• SDEP: The full SDEP program, which will be developed by physical therapists, 
orthopaedic trauma surgeons, and investigators with experience in health behavior 
change, will be designed to maximize adherence/compliance with the program 
• Standard of Care-Surgeon Exercise Instructions (SOC-SEI): stretching and range of 
motion instructions given by the treating surgeon or ACP. 
Observational cohort 
 Patients who are unwilling to be randomized will be enrolled in an observational arm of the 
study. They will be asked to complete all baseline and follow-up assessments, and 

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participation in formal PT or SOC-SEI will be documented. 
 
 
Data Collection: Patients will be assessed at baseline and then at 3, 6, and 12 months after 
hospital discharge. Demographic characteristics including co-morbidities, pre-injury health 
status and function, socioeconomic status, usual major activity prior to injury, education, and 
insurance status will be documented at the time of enrollment. Injury characteristics including 
associated injuries, hospital length of stay, and in-hospital complications will be collected. 
Fracture healing and weight-bearing status, as well as any complications, including 
readmissions and reoperations will be documented. Psychosocial characteristics that may 
impact outcomes (self-efficacy, patient activation, fear of movement/re-injury, resiliency, and 
depression) will be assessed at baseline and all follow-up visits. 
 
Instrument 
Baseline 
3 months 
6-months 
12-months 
Patient Characteristics 
X 
 
 
 
Medical History 
X 
 
 
 
Work Productivity and Activity Impairment 
Questionnaire (WPAI) 
X 
x 
X 
X 
Paffenbarger Physical Activity 
Questionnaire 
X 
x 
X 
X 
Pain Self-Efficacy Questionnaire (PSEQ) 
X 
x 
X 
X 
Connor-Davidson Resilience Scale (CD-
RISC) 
X 
x 
X 
X 
Tampa Scale for Kinesiophobia (TSK) 
X 
x 
X 
X 
Pain Catastrophizing Scale (PCS) 
X 
x 
X 
X 
Veterans RAND 12 Item Health Survey 
(VR-12) 
X 
x 
X 
X 
PROMIS Pain Interference Short Form 
 
x 
X 
X 
PROMIS Physical Function Short Form 
 
x 
X 
X 
PROMIS Global Health 
 
x 
X 
X 
Brief Pain Inventory (BPI) 
 
x 
X 
X 
Return to Usual Major Activity (RUMA) 
 
x 
X 
X 
Clinical Follow-up Form 
 
x 
X 
X 
Performance tests w/ IMU- at each clinic 
visit 
 
x 
x 
x 
 
Primary and Secondary Outcomes: The primary outcome measure for the study will be return 
to work/major activities. Secondary outcomes include the  pain, functional status, health-related 
quality of life, physical activity, kinesiophobia, depression, psychosocial risk factors, time to 
recovery, range of motion assessed using a goniometer, and strength assessed using a stabilized 
hand held force gauge. Outcome measures covering multiple areas will be used to ensure that 
the potential benefits and/or limitations associated with selected interventions are effectively 
captured.  
 
Secondary functional outcomes will be assessed with a battery of validated performance-
based tests captured via the Mobility Toolkit (10m walk test, Timed Up and Go) at each clinic 
visit.  The Mobility Toolkit is a HIPAA compliant, web-accessible, cloud-based application for 

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capturing performance tests in multiple clinics.  It is built on a 
Microsoft Azure platform with custom MATLAB analytics.  The 
mobility toolkit application currently allows us to gait test patients and 
compare their results over time (i.e. rehab trajectories) or compare 
results versus similar patients or matched non-injured controls.  The 
data are captured by an Inertial Measurement Unit (IMU) that is chest-
mounted, positioned at the top of the sternum using a simple harness 
(Figure 1). The IMU is a wireless-telemetry, 10 degree-of-freedom IMU 
which includes a tri-axial accelerometer, a tri-axial gyroscope, a tri-
axial magnetometer and an onboard temperature sensor. Custom 
software has been developed to appropriately filter the raw data, establish a fixed global 
coordinate system (i.e. aligned with the body coordinate system), segregate gait segment data 
from turn data, and delineate and compile data for left and right strides for separate analyses. 
The software is also used to calculate quantitative descriptors of gait which are observable 
during subjective gait evaluation but not readily quantified. Set up and test time for the IMU is 
approximately 5 minutes and can be performed in almost any setting, including outpatient 
clinics. 
 
4. Sample Size and Analysis Plan.  The primary purpose of this study is to provide preliminary 
estimates of efficacy of the intervention and data supporting the feasibility of randomizing 
patients to two alternate types of rehabilitation services. Data will be used to determine the 
need for, and to power, a larger randomized trial of the intervention. The sample size of 60 
patients per arm will allow us to calculate a confidence interval for the difference in mean 
PROMIS Physical Function scores between the two treatment groups assuming a common 
standard deviation of PROMIS Physical Function scores in the treatment groups of 17. 
 
5. Potential Risk 
The is a small risk of falling during the performance tests. These tests will be performed under 
close supervision by trained Research Coordinators using standard operating procedures.  
 
Any time information is collected for a study, there is a small risk of breach of confidentiality. 
However, this risk is not greater than the risk that already exists in clinical settings when 
handling medical data. 
 
6. Potential Benefits 
The physical therapy intervention may or may not be better than the physical therapy program 
that would be prescribed to the participant outside of this study. In addition, study participants 
may experience satisfaction in knowing that the results of the study could help determine the best 
physical therapy program 
 
7. Data Management and Storage.   
The Department of Orthopaedic Surgery utilizes the NIH-funded Research Electronic Data 
Capture (REDCap) project for all data management and stor-age. REDCap is a state of the art, 
metadata driven application for distributed data collection and data management in clinical 
studies. 
Security. Privacy and security are central considerations for distributed data systems with ac-cess 

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to Personally Identifiable Information (PII). The overall private website will be secured with a 
challenge/response password protection mechanism. An additional level of security, requiring 
entry of a unique individual password, further protects access to the REDCap data management 
system. Numerous steps are being taken to maintain the integrity and security of the data sys-
tem.  First and foremost among these is the provision of careful training, certification, and guid-
ance to all research staff.  Each user account will have its own password and staff will be trained 
to recognize as misconduct the sharing of passwords. 
Distributed Data System. The REDCap data management allows for a web-based, distributed 
data entry system using most web browsers to access an internet-connected database server. The 
system will permit research staff to have access to data as soon as they are entered, allow-ing for 
near-real-time recruitment reports and increased data entry availability and convenience for the 
clinical sites. The primary functions of the data system include the following existing fea-tures of 
the REDCap application: registration of all candidates for the trial; entry of all study data forms; 
inventory, management, and editing of study data; maintenance of full audit trails of all data 
entry and editing; and real time performance report generation. The REDCap data entry system 
also includes extensive data validation functionalities, including field level validation (i.e., 
checking the correct format and range of each entered item, intra-form validation, checking for 
logic errors, skip pattern violations across items on a form; and inter-form validation, checking 
for inconsistencies across forms). 
Data Export and Reporting. REDCap has a number of built-in data export capabilities, includ-ing 
the capacity to directly produce data files for several common statistical analysis and data 
management packages (Microsoft Excel, SPSS, SAS, R, Stata).  In addition, a well-developed 
report generation utility makes it possible to extract real-time information in support of perfor-
mance monitoring, quality assurance, and Data and Safety Monitoring Board interim reports. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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