Short-term effect of a carbon fiber custom dynamic orthosis and integrated rehabilitation on self-reported physical function, pain, speed, and agility in civilians.

BACKGROUND: Ankle-foot orthoses (AFOs) are widely used to restore mobility and reduce pain in individuals with lower extremity pain and disability. The use of a carbon fiber custom dynamic orthosis (CDO) with integrated physical training and psychosocial intervention has been shown to improve outcomes in a military setting, but civilian data are limited. OBJECTIVES: To use existing clinical data to evaluate the initial effectiveness of an integrated CDO and rehabilitative program and identify baseline characteristics that impact patient response to the intervention. STUDY DESIGN: Retrospective cohort. METHODS: Records of 131 adult patients who received a CDO and device specific training were reviewed. Patient-reported measures of pain and lower extremity function and physical measurements of walking and agility were extracted at baseline and on training completion. RESULTS: A majority of patients reported improved or greatly improved physical function (92%), maximum pain (69%), and typical pain (55%) and experienced improved or greatly improved walking speed (92%) and agility (52%) irrespective of age and sex. Regression models for examining short-term improvement in pain and physical function accounted for 52% (p < 0.001) and 26% (p < 0.001) of the outcome variance, respectively. Improvement in typical pain was influenced by baseline typical and maximum pain, and functional improvement was influenced by sex and baseline physical function. CONCLUSIONS: Most patients (92.4%) reported a positive initial outcome after intervention as measured using patient-reported and objective measures.

Predictors of long-term pain and function in individuals who received a custom dynamic orthosis and device-centric care pathway.

INTRODUCTION: Carbon fiber custom dynamic orthoses (CDOs) have been shown to effectively reduce pain and improve function in military service members with lower-limb impairment, but data are limited for civilians. OBJECTIVES: To evaluate the long-term outcomes of individuals who completed a CDO-centric care pathway in a civilian clinic by comparing baseline pain, mobility, and function with outcomes at long-term follow-up. To identify baseline characteristics and postintervention outcomes predictive of outcomes at long-term follow-up. METHODS: Records of 131 adult patients who received a CDO and CDO-centric training were reviewed. Patient-reported measures of pain and physical function and timed assessment of walking and agility collected during routine clinical care were extracted. These patients were contacted on average 4 (±1) years postintervention to complete a survey including measures of pain and physical function. RESULTS: The 63 participants who responded reported improved or greatly improved function, maximum pain, and typical pain on average, irrespective of age or sex (P < 0.001). Change in function from baseline to long-term follow-up was predicted by short-term change in function (35.1% of the variance; P < 0.001). Change in pain from baseline to long-term follow-up was predicted by baseline typical pain and change in four square step test time (63% of variance; P < 0.001). CONCLUSIONS: Most survey respondents reported positive outcomes. Long-term pain reduction and improved function were predicted by baseline status and by short-term changes associated with receiving a CDO and completing an intensive training program.

Physical Performance Limitations After Severe Lower Extremity Trauma in Military Service Members.

OBJECTIVES: To characterize the type and magnitude of lower extremity physical performance deficits in military service members who have undergone rehabilitation after limb salvage or transtibial amputation. DESIGN: Cross-sectional prospective. SETTING: Level I trauma military medical and rehabilitation center. PATIENTS/PARTICIPANTS: Service members with lower extremity trauma resulting in limb salvage (n = 20) or unilateral transtibial amputation (n = 14) compared with uninjured actively training service members (n = 123). INTERVENTION: Control participants and individuals with amputation were tested during a single session. Participants with limb salvage were tested with and without the use of a custom carbon fiber orthosis. MAIN OUTCOME MEASUREMENTS: Physical performance as measured using four-square step, sit-to-stand 5 times, and timed stair ascent tests. Secondary outcomes included the associations between these lower extremity activity measures to determine the interrelationship of activity limitations. RESULTS: The ability of service members to rapidly ascend stairs, a demanding lower limb mobility task, is limited after amputation and limb salvage. However, performance on an agility test similar to the four-square step test approximated normative levels. Differences between individuals with amputation or limb salvage were less than 1 second for all tests and were not statistically significant. Correlations were observed among the physical performance measures in the tested patient populations, particularly between the sit-to-stand and timed stair ascent tests. CONCLUSIONS: Severe limb trauma significantly affects performance, particularly during tasks requiring lower extremity strength and power. Individuals with amputation or limb salvage who were provided a custom carbon fiber orthosis and intensive rehabilitation had similar performance. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Biomechanical response to ankle-foot orthosis stiffness during running.

BACKGROUND: The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is an ankle-foot orthosis developed to address the high rates of delayed amputation in the military. Its use has enabled many wounded Service Members to run again. During running, stiffness is thought to influence an orthosis' energy storage and return mechanical properties. This study examined the effect of orthosis stiffness on running biomechanics in patients with lower limb impairments who had undergone unilateral limb salvage. METHODS: Ten patients with lower limb impairments underwent gait analysis at a self-selected running velocity. 1. Nominal (clinically-prescribed), 2. Stiff (20% stiffer than nominal), and 3. Compliant (20% less stiff than nominal) ankle-foot orthosis stiffnesses were tested. FINDINGS: Ankle joint stiffness was greatest in the stiffest strut and lowest in the compliant strut, however ankle mechanical work remained unchanged. Speed, stride length, cycle time, joint angles, moments, powers, and ground reaction forces were not significantly different among stiffness conditions. Ankle joint kinematics and ankle, knee and hip kinetics were different between limbs. Ankle power, in particular, was lower in the injured limb. INTERPRETATION: Ankle-foot orthosis stiffness affected ankle joint stiffness but did not influence other biomechanical parameters of running in individuals with unilateral limb salvage. Foot strike asymmetries may have influenced the kinetics of running. Therefore, a range of stiffness may be clinically appropriate when prescribing ankle-foot orthoses for active individuals with limb salvage.

How does ankle-foot orthosis stiffness affect gait in patients with lower limb salvage?

BACKGROUND: Ankle-foot orthoses (AFOs) are commonly prescribed during rehabilitation after limb salvage. AFO stiffness is selected to help mitigate gait deficiencies. A new custom dynamic AFO, the Intrepid Dynamic Exoskeletal Orthosis (IDEO), is available to injured service members but prescription guidelines are limited. QUESTIONS/PURPOSES: In this study we ask (1) does dynamic AFO stiffness affect gait parameters such as joint angles, moments, and powers; and (2) can a given dynamic AFO stiffness normalize gait mechanics to noninjured control subjects? METHODS: Thirteen patients with lower limb salvage (ankle arthrodesis, neuropathy, foot/ankle reconstruction, etc) after major lower extremity trauma and 13 control subjects who had no lower extremity trauma and wore no orthosis underwent gait analysis at a standardized speed. Patients wore their custom IDEO with posterior struts of three different stiffnesses: nominal (clinically prescribed stiffness), compliant (20% less stiff), and stiff (20% stiffer). Joint angles, moments, powers, and ground reaction forces were compared across the varying stiffnesses of the orthoses tested and between the patient and control groups. RESULTS: An increase in AFO compliance resulted in 20% to 26% less knee flexion relative to the nominal (p = 0.003) and stiff (p = 0.001) conditions, respectively. Ankle range of motion and power generation were, on average, 56% (p < 0.001) and 63% (p < 0.001), respectively, less than controls as a result of the relatively fixed ankle position. CONCLUSIONS: Patients with limb salvage readily adapted to different dynamic AFO stiffnesses and demonstrated few biomechanical differences among conditions during walking. None of the stiffness conditions normalized gait to controls. CLINICAL RELEVANCE: The general lack of differences across a 40% range of strut stiffness suggests that orthotists do not need to invest large amounts of time identifying optimal device stiffness for patients who use dynamic AFOs for low-impact activities such as walking. However, choosing a stiffer strut may more readily translate to higher-impact activities and offer less chance of mechanical failure.

Can an integrated orthotic and rehabilitation program decrease pain and improve function after lower extremity trauma?

BACKGROUND: Patients with severe lower extremity trauma have significant disability 2 years after injury that worsens by 7 years. Up to 15% seek late amputation. Recently, an energy-storing orthosis demonstrated improved function compared with standard orthoses; however, the effect when integrated with rehabilitation over time is unknown. QUESTIONS/PURPOSES: (1) Does an 8-week integrated orthotic and rehabilitation initiative improve physical performance, pain, and outcomes in patients with lower extremity functional deficits or pain? (2) Is the magnitude of recovery different if enrolled more than 2 years after their injury versus earlier? (3) Does participation decrease the number considering late amputation? METHODS: We prospectively evaluated 84 service members (53 less than and 31 > 2 years after injury) who enrolled in the initiative. Fifty-eight sustained fractures, 53 sustained nerve injuries with weakness, and six had arthritis (there was some overlap in the patients with fractures and nerve injuries, which resulted in a total of > 84). They completed 4 weeks of physical therapy without the orthosis followed by 4 weeks with it. Testing was conducted at Weeks 0, 4, and 8. Validated physical performance tests and patient-reported outcome surveys were used as well as questions pertaining to whether patients were considering an amputation. RESULTS: By 8 weeks, patients improved in all physical performance measures and all relevant patient-reported outcomes. Patients less than and greater than 2 years after injury improved similarly. Forty-one of 50 patients initially considering amputation favored limb salvage at the end of 8 weeks. CONCLUSIONS: We found this integrated orthotic and rehabilitation initiative improved physical performance, pain, and patient-reported outcomes in patients with severe, traumatic lower extremity deficits and that these improvements were sustained for > 2 years after injury. Efforts are underway to determine whether the Return to Run clinical pathway with the Intrepid Dynamic Exoskeletal Orthosis (IDEO) can be successfully implemented at additional military centers in patients > 2 years from injury while sustaining similar improvements in patient outcomes. The ability to translate this integrated orthotic and rehabilitation program into the civilian setting is unknown and warrants further investigation.

Return to duty after integrated orthotic and rehabilitation initiative.

OBJECTIVES: To determine the return to active duty rate of military service members undergoing lower extremity limb salvage while using a novel custom orthosis and specialized rehabilitation compared with those receiving a novel custom orthosis alone. DESIGN: Retrospective cohort study. SETTING: Military level I trauma center and tertiary referral center for limb salvage. PATIENTS/PARTICIPANTS: All active duty service members enrolled in our institution's Return to Run Clinical Pathway were analyzed retrospectively. Service members were enrolled if they sustained injuries with residual disability below the knee. Injuries typically involved substantial motor and/or nerve deficit, and the overwhelming majority was secondary to high-energy injuries. INTERVENTION: Service members were fitted with a customized orthosis, an Intrepid Dynamic Exoskeletal Orthosis (IDEO), for use during rehabilitation. Service members were divided into 2 groups: those who had participated in the Return to Run Clinical Pathway with an IDEO (group 1) and those who only were fitted with an IDEO only (group 2). MAIN OUTCOME MEASURE: Return to military active duty rate. RESULTS: One hundred forty-six service members met the inclusion criteria. Group 1 consisted of 115 service members and group 2 consisted of 31 service members. Of those in group 1, 59 (51.3%) returned to active duty compared with 4 (12.9%) in group 2 (P = 0.0001). Mechanisms of injury were significant factors for return to duty (RTD), and those sustaining explosive mechanisms of injury or gunshot wounds had significantly lower RTD rates across both groups. CONCLUSIONS: Active duty service members participating in an integrated orthotic and rehabilitation initiative after a lower extremity injury have a higher rate of RTD than previous reports, and it is significantly higher than the orthotic device alone.

Management of posttraumatic osteoarthritis with an integrated orthotic and rehabilitation initiative.

Posttraumatic osteoarthritis affects approximately 5.6 million Americans annually. Those affected are typically younger and more active than persons with primary osteoarthritis. Arthrodesis is the typical management option for persons with end-stage ankle and subtalar posttraumatic arthritis. Arthroplasty is typically reserved for elderly persons. The functional limitations resulting from any of these strategies make treatment of this young population challenging. Combat wounds frequently lead to severe lower extremity injuries. We present a series of patients with severe posttraumatic osteoarthritis of the ankle and subtalar joint after combat trauma. They were treated at our institution with an integrated orthotic and rehabilitation initiative called the Return To Run clinical pathway. This clinical pathway may serve as an alternative or adjunct to arthrodesis and arthroplasty for young patients with severe posttraumatic osteoarthritis of the ankle and subtalar joint.

Deployment after limb salvage for high-energy lower-extremity trauma.

BACKGROUND: Many wounded warriors experienced high-energy lower-extremity trauma (HELET) that may be limb threatening. Volumetric muscle loss, posttraumatic osteoarthritis, nerve injuries, and pain may severely limit physical function. Several wounded warriors express a strong desire to return to their units and be deployed in their original military occupational specialty. We began the return-to-run (RTR) clinical pathway at our institution 2 years ago to facilitate high-performance goals such as these. It involves an energy storing ankle foot orthosis, the intrepid dynamic exoskeletal orthosis in combination with high-intensity, progression-oriented rehabilitation. We sought to determine the rate of deployment or predeployment training after participation in this noninvasive intervention. METHODS: A retrospective analysis of the RTR database was performed to determine the rate of deployment or predeployment training among those service members who began participation in the RTR between November of 2009 and March of 2011. Medical records were reviewed for demographics, injury, surgical data, and major complications. Requests for delayed amputation were recorded, and charts were reviewed to determine if patients eventually elected to proceed with amputation or if they chose to continue with limb salvage. RESULTS: Between November 2009 and March 2011, 87 service members completed the RTR. Of these, 17 (19.5%) have been deployed to combat or are in predeployment training. Sixteen serve in combat arms (nine Special Forces, four infantry/ranger, two combat engineers, and one gunner), and one is a member of the military intelligence community. Fifteen patients sustained their injuries as a result of HELET (four gunshot, five motor vehicle collisions, four explosions, one parachute injury, and one fall from height), one had idiopathic avascular necrosis of the talus, and one had an iatrogenic nerve injury after pelvic surgery. Six of the patients underwent circular external fixation, five received joint fusions (three ankle, two subtalar joint), and nine had major nerve injuries. Four initially desired amputation of their injured limb but have subsequently countermanded their request. CONCLUSION: Returning to high-level physical function after HELET is challenging. After implementation of the RTR clinical pathway with the intrepid dynamic exoskeletal orthosis, 19.5% of wounded warriors treated with the RTR have been deployed or will be deployed in the coming year.

Comparative effect of orthosis design on functional performance.

BACKGROUND: High-energy extremity trauma is common in combat. Orthotic options for patients whose lower extremities have been salvaged are limited. A custom energy-storing ankle-foot orthosis, the Intrepid Dynamic Exoskeletal Orthosis (IDEO), was created and used with high-intensity rehabilitation as part of the Return to Run clinical pathway. We hypothesized that the IDEO would improve functional performance compared with a non-custom carbon fiber orthosis (BlueRocker), a posterior leaf spring orthosis, and no brace. METHODS: Eighteen subjects with unilateral dorsiflexion and/or plantar flexion weakness were evaluated with six functional tests while they were wearing the IDEO, BlueRocker, posterior leaf spring, or no brace. The brace order was randomized, and five trials were completed for each of the functional measures, which included a four-square step test, a sit-to-stand five times test, tests of self-selected walking velocity over level and rocky terrain, and a timed stair ascent. They also completed one trial of a forty-yard (37-m) dash, filled out a satisfaction questionnaire, and indicated whether they had ever considered an amputation and, if so, whether they still intended to proceed with it. RESULTS: Performance was significantly better with the IDEO with respect to all functional measures compared with all other bracing conditions (p < 0.004), with the exception of the sit-to-stand five times test, in which there was a significant improvement only as compared with the BlueRocker (p = 0.014). The forty-yard dash improved by approximately 35% over the values for the posterior leaf spring and no-brace conditions, and by 28% over the BlueRocker. The BlueRocker demonstrated a significant improvement in the forty-yard dash compared with no brace (p = 0.033), and a significant improvement in self-selected walking velocity on level terrain compared with no brace and the posterior leaf spring orthosis (p < 0.028). However, no significant difference was found among the posterior leaf spring, BlueRocker, and no-brace conditions with respect to any other functional measure. Thirteen patients initially considered amputation, but after completion of the clinical pathway, eight desired limb salvage, two were undecided, and three still desired amputation. CONCLUSIONS: Use of the IDEO significantly improves performance on validated tests of agility, power, and speed. The majority of subjects initially considering amputation favored limb salvage after this noninvasive intervention.

Return to running and sports participation after limb salvage.

BACKGROUND: The ability to return to running and sports participation after lower extremity limb salvage has not been well documented previously. Although the ability to ambulate without pain or assistive devices is generally a criteria for a good limb salvage outcome, many patients at our institution have expressed a desire to return to a more athletic lifestyle to include running and sports participation. The purpose of this study was to investigate the types of athletic endeavors our high-energy lower extremity trauma patients were able to pursue after limb salvage. METHODS: We retrospectively analyzed lower extremity limb salvage patients who were at least 12 weeks status after external fixation removal and participated in our limb salvage return-to-running clinical pathway. Patients were rehabilitated to their highest functional level through a sports medicine-based approach. A custom energy-storing ankle-foot orthosis was implemented to help augment plantarflexion strength in conjunction with running gait retraining. RESULTS: The first 10 patients to complete the clinical pathway were identified. All patients were treated at the same institution by the same orthopedic surgeon and physical therapist. Eight patients have returned to running, and 10 patients have returned to weight-lifting. Seven patients have returned to cycling, three have returned to golf, three to basketball, and two to softball. Two patients have completed a mini-triathlon. CONCLUSION: Aggressive rehabilitation, an energy-storing ankle-foot orthosis, and running gait retraining can restore an active recreational lifestyle to patients who have undergone lower extremity limb salvage.

Can an ankle-foot orthosis change hearts and minds?

The current military conflicts of Operation Enduring Freedom and Operation Iraqi Freedom have been characterized by high-energy explosive wounding patterns, with the majority affecting the extremities. While many injuries have resulted in amputation, surgical advances have allowed the orthopaedic surgeon to pursue limb salvage in the face of injuries once considered unsalvageable. The military limb salvage patient is frequently highly active and motivated and expresses significant frustration with the slow nature of limb salvage rehabilitation and continued functional deficits. Inspired by these patients, efforts at this institution began to provide them with a more dynamic orthosis. Utilizing techniques and technology resulting from cerebral palsy, stroke, and amputation research, the Intrepid Dynamic Exoskeletal Orthosis was created. To date, this device has significantly improved the functional capabilities of the limb salvage wounded warrior population when combined with a high-intensity rehabilitation program. Clinical and biomechanical research is currently underway at this institution in order to fully characterize the device, its effect on patients, and what can be done to modify future generations of the device to best serve the combat-wounded limb salvage population.