Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study.

INTRODUCTION: Upper and lower limb spasticity is commonly associated with central nervous system disorders including stroke, traumatic brain injury, multiple sclerosis, cerebral palsy, and spinal cord injury, but little is known about the concurrent treatment of upper and lower limb spasticity with botulinum toxins. OBJECTIVE: To evaluate onabotulinumtoxinA (onabotA) utilization and to determine if concurrent onabotA treatment of the upper and lower limbs has supported improvements in participants with spasticity. DESIGN: Sub-analysis of a 2-year, international, prospective, observational registry (ASPIRE, NCT01930786). SETTING: International clinic sites (54). PARTICIPANTS: Adult spasticity participants across etiologies, who received ≥1 concurrent onabotA treatment of the upper and lower limbs during the study. INTERVENTION: Participants were treated with onabotA at the clinician's discretion. OUTCOMES: Baseline characteristics and outcomes of disability (Disability Assessment Scale [DAS]), pain (Numeric Pain Rating Scale [NPRS]), participant satisfaction, physician satisfaction, and quality of life (QoL; Spasticity Impact Assessment [SIA]) were evaluated. Adverse events were monitored throughout the study. RESULTS: Of 744 participants enrolled, 730 received ≥1 dose of onabotA; 275 participants received treatment with onabotA in both upper and lower limbs during ≥1 session; 39.3% of participants were naïve to onabotA for spasticity. The mean (SD) total dose per treatment session ranged from 421.2 (195.3) to 499.6 (188.6) U. The most common baseline upper limb presentation was clenched fist (n = 194, 70.5%); lower limb was equinovarus foot (n = 219, 66.9%). High physician and participant satisfaction and improvements in pain, disability and QoL were reported after most treatments. Nine participants (3.3%) reported nine treatment-related adverse events; two participants (0.7%) reported three serious treatment-related severe adverse events. No new safety signals were identified. CONCLUSION: More than a third of enrolled participants received at least one concurrent onabotA treatment of the upper and lower limbs, with reduced pain, disability, and improved QoL after treatment, consistent with the established safety profile of onabotA for the treatment of spasticity.

Safety and Real-World Dosing of OnabotulinumtoxinA for the Treatment of Adult Spasticity: Post Hoc Analysis of the Adult Spasticity International Registry Study.

OBJECTIVE: The aim of the study is to evaluate the safety of onabotulinumtoxinA treatment for spasticity across dose ranges in real-world practice. DESIGN: Adult Spasticity International Registry was a multicenter, prospective, observational study (NCT01930786) of onabotulinumtoxinA treatment for adult spasticity over 2 yrs. Adverse events, serious adverse events, treatment-related adverse events, and serious treatment-related adverse events were sorted into five categories (≤200, 201-400, 401-600, 601-800, ≥801 U) based on cumulative dose per session. RESULTS: In 3103 treatment sessions ( T ), 730 patients received ≥1 dose of onabotulinumtoxinA. Dose categories included the following: ≤200 U ( n = 312, T = 811), 201-400 U ( n = 446, T = 1366), 401-600 U ( n = 244, T = 716), 601-800 U ( n = 69, T = 149), and ≥801 U ( n = 29, T = 61). Of these patients, 261 reported 827 adverse events, 94 reported 195 serious adverse events, 20 reported 23 treatment-related adverse events, and 2 patients treated with 201-400 U onabotulinumtoxinA reported 3 serious treatment-related adverse events. Treatment-related adverse events reported included ≤200 U (8/811, 0.9%), 201-400 U (7/1366, 0.5%), 401-600 U (6/716, 0.8%), 601-800 U (1/149, 0.7%), and ≥801 U (1/61, 1.6%). CONCLUSIONS: In this post hoc analysis, most treatment sessions were performed with 201-400 U onabotulinumtoxinA. Patients treated with 201-400 U onabotulinumtoxinA had an adverse event profile consistent with onabotulinumtoxinA package inserts globally (e.g., United States, European Union, United Kingdom, Canada). No new safety signals were identified.

Healthcare resource utilization and costs among patients with post-stroke spasticity before and after spasticity management including onabotulinumtoxina.

BACKGROUND: Real-world data regarding the impact of onabotulinumtoxinA on healthcare resource utilization and costs for post-stroke spasticity are scarce. OBJECTIVE: To compare differences in 12-month healthcare resource utilization and costs before and after post-stroke spasticity management including onabotulinumtoxinA. METHODS: This retrospective claims analysis of IBM MarketScan Commercial and Medicare Supplemental databases included adults with ≥ 1 onabotulinumtoxinA claim for post-stroke spasticity (1 January 2010 to 30 June 2018) and continuous enrolment for ≥ 12 months pre- and post-index (first onabotulinumtoxinA claim date). All-cause and spasticity-related healthcare resource utilization and costs were compared 12 months pre- and post-index (McNemar's χ2 test or paired t-test). A subgroup analysis assessed effect of stroke-to-index interval on costs. RESULTS: Among 735 patients, mean (standard deviation) stroke-date-to-index-date interval was 284.5 (198.8) days. Decreases were observed post-index for mean all-cause outpatient (62.9 vs 60.5; p ≤ 0.05) and emergency department visits (1.1 vs 0.8; p ≤ 0.0001), and hospital admissions (1.5 vs 0.4; p ≤ 0.0001). Increase in prescription fills (43.0 vs 53.7) was seen post-index. Post-index decreases in all-cause (-66%) and spasticity-related (-51%) costs were driven by reduced inpatient care costs. Findings were consistent regardless of stroke-date-to-index-date interval. CONCLUSION: Significant reductions in healthcare resource utilization and costs were observed after 1 year of post-stroke spasticity management including onabotulinumtoxinA. Long-term studies are needed to establish causality.

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation.

INTRODUCTION: Practicality of implementation and dosing of supplemental gait training in an acute stroke inpatient rehabilitation setting are not well studied but can have positive impact on outcomes. OBJECTIVES: To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery. DESIGN AND SETTING: Assessor blinded, randomized controlled trial in a tertiary Inpatient Rehabilitation Facility. PARTICIPANTS: Thirty acute post-stroke patients with unilateral hemiparesis (≥ 18 years of age with a lower limb MAS ≤ 3). INTERVENTION: Lokomat® or conventional gait training (CGT) in addition to standard mandated therapy time. MAIN OUTCOME MEASURES: Number of therapy sessions; adverse events; functional independence measure (FIM motor); functional ambulation category (FAC); passive range of motion (PROM); modified Ashworth scale (MAS); 5 times sit-to-stand (5x-STS); 10-m walk test (10MWT); 2-min walk test (2MWT) were assessed before (pre) and after training (post). RESULTS: The desired supplemental therapy was implemented during normal care delivery hours and the patients generally tolerated the sessions well. Both groups improved markedly on several measures; the CGT group obtained nearly 45% more supplemental sessions (12.8) than the Lokomat® group (8.9). Both groups showed greater FIM improvement scores (discharge - admission) than those from a reference group receiving no supplemental therapy. An overarching statistical comparison between methods was skewed towards a differential benefit (but not significant) in the Lokomat® group with medium effect sizes. By observation, the robotic group completed a greater number of steps, on average. These results provide some evidence for Lokomat® being a more efficient tool for gait retraining by providing a more optimal therapy "dose". CONCLUSIONS: With careful planning, supplemental therapy was possible with minimal intrusion to schedules and was well tolerated. Participants showed meaningful functional improvement with relatively little supplemental therapy over a relatively short time in study.

Clinical presentation of patients with lower limb spasticity undergoing routine treatment with botulinum toxin: baseline findings from an international observational study.

OBJECTIVE: Describe how people with lower limb spasticity present for treatment in routine clinical practice. METHODS: Prospective, observational study (Clinicaltrials.gov: NCT04050527) of ambulatory adult patients (≥ 18 years) with unilateral lower limb spasticity (able to take ≥ 5 steps with or without assistance) presenting for routine spasticity management, including treatment with abobotulinumtoxinA. RESULTS: The study population included 430 adults with lower limb spasticity. Despite their relatively young age (mean ± standard deviation 53.7 ± 13.9 years), only 20% of patients were employed. Most patients had an acquired brain injury due to cerebrovascular disease; 84.1% reported having concomitant upper limb spasticity. Using the Leg Activity Measure, most patients reported no or only mild difficulties in performing hygiene/positioning tasks, while 80.7% had at least mild difficulty with indoor ambulation and 90.5% had at least mild difficulty with walking outdoors. Sensory, communication and/or cognitive impairments were also common. At the first treatment cycle, 50.7% of patients set active function primary goals, including locomotion transferring or standing. CONCLUSION: These observations highlight the complexity of presentation that must be considered when setting treatment goals for lower limb spasticity and emphasize the types of impairment and activity (functional) limitations that treating teams may expect to encounter in their patients and should cover in their initial and follow-up assessments.

Treatment of adult spasticity with Botox (onabotulinumtoxinA): Development, insights, and impact.

Upper and lower limb spasticity (ULS, LLS) often occur following a stroke or in patients with other neurological disorders, leading to difficulties in mobility and daily living and decreased quality of life. Prior to the use of onabotulinumtoxinA, antispastic medications had limited efficacy and often caused sedation. Phenol injections were difficult for physicians to perform, painful, and led to tissue destruction. The success of onabotulinumtoxinA in treating cervical dystonia led to its use in spasticity. However, many challenges characterized the development of onabotulinumtoxinA for adult spasticity. The wide variability in the presentation of spasticity among patients rendered it difficult to determine which muscles to inject and how to measure improvement. Another challenge was the initial refusal of the Food and Drug Administration to accept the Ashworth Scale as a primary endpoint. Additional scales were designed to incorporate a goal-oriented, patient-centered approach that also accounted for the variability of spasticity presentations. Several randomized, double-blind, placebo-controlled trials of post-stroke spasticity of the elbow, wrist, and/or fingers showed significantly greater improvements in the modified Ashworth Scale and patient treatment goals and led to the approval of onabotulinumtoxinA for the treatment of ULS in adult patients. Lessons learned from the successful ULS trials were applied to design an LLS trial that led to approval for the latter indication. Additional observational trials mimicking real-world treatment have shown continued effectiveness and patient satisfaction. The use of onabotulinumtoxinA for spasticity has ushered in a more patient-centered treatment approach that has vastly improved patients' quality of life.

Video enhanced visual analysis of hemiparetic gait muscle selection: A pilot study.

This paper summarizes the use of video enhanced visual analysis (VEVA) as a muscle selection assistance method for abnormal foot postures in adults with upper motor neuron syndrome (UMNS) treated with botulinum neurotoxin (BoNT-A) in a real-world setting. This pilot study used a prospective treatment study design with persons in an outpatient, rehabilitation hospital. Participants had acquired brain injury (ABI) of >6-month duration who had a spastic ankle foot deformity amenable to treatment with botulinum toxin A and able to independently ambulate a minimum of 10 m. Participants were evaluated before abobotulinumtoxinA injection (500 U-1500 U) to the identified lower limb muscles and four to five weeks post injection. Main Outcome Measures: Temporal spatial data (self-selected and maximal walking velocities (SSWV/MWV); step length and stance time); Modified Ashworth Scale (MAS); Tardieu Scale (TS) and ankle Passive Range of Motion (PROM) change from baseline to follow-up (f/u). Data is presented on ten of the eleven consecutive participants enrolled in the study. One participant withdrew due to study unrelated opposite ankle pain before reassessment. Mean SSWV increased post treatment by 21% in the barefoot condition and 8% when walking with shoes. For the MWV condition, there was a 15% mean increase post treatment in the barefoot condition and 10% when walking with shoes. Participants showed improved symmetry in step length and stance time in both post-treatment walking conditions. Ankle MAS and TS improved with knee flexed or extended. Ankle PROM increased post treatment with knee flexed by 8° and knee extended by 11.7°. VEVA in addition to clinical evaluation appears to facilitate muscle identification and selection of ankle deformities for treatment with BoNT-A. Our findings show marked improvement in ankle MAS, TS and PROM as indicators of pharmacological activity and increase in SSWV as a marker of functional improvement.

Telerehabilitation Initiated Early in Post-Stroke Recovery: A Feasibility Study.

BACKGROUND: Enhanced neural plasticity early after stroke suggests the potential to improve outcomes with intensive rehabilitation therapy. Most patients do not get such therapy, however, due to limited access, changing rehabilitation therapy settings, low therapy doses, and poor compliance. OBJECTIVE: To examine the feasibility, safety, and potential efficacy of an established telerehabilitation (TR) program after stroke initiated during admission to an inpatient rehabilitation facility (IRF) and completed in the patient's home. METHODS: Participants with hemiparetic stroke admitted to an IRF received daily TR targeting arm motor function in addition to usual care. Treatment consisted of 36, 70-minute sessions (half supervised by a licensed therapist via videoconference), over a 6-week period, that included functional games, exercise videos, education, and daily assessments. RESULTS: Sixteen participants of 19 allocated completed the intervention (age 61.3 ± 9.4 years; 6 female; baseline Upper Extremity Fugl-Meyer [UEFM] score 35.9 ± 6.4 points, mean ± SD; NIHSS score 4 (3.75, 5.25), median, IQR; intervention commenced 28.3 ± 13.0 days post-stroke). Compliance was 100%, retention 84%, and patient satisfaction 93%; 2 patients developed COVID-19 and continued TR. Post-intervention UEFM improvement was 18.1 ± 10.9 points (P < .0001); Box and Blocks, 22.4 ± 9.8 blocks (P = .0001). Digital motor assessments, acquired daily in the home, were concordant with these gains. The dose of rehabilitation therapy received as usual care during this 6-week interval was 33.9 ± 20.3 hours; adding TR more than doubled this to 73.6 ± 21.8 hours (P < .0001). Patients enrolled in Philadelphia could be treated remotely by therapists in Los Angeles. CONCLUSIONS: These results support feasibility, safety, and potential efficacy of providing intense TR therapy early after stroke. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov; NCT04657770.

Efficacy of Early Inpatient Rehabilitation of Post-COVID-19 Survivors: Single-Center Retrospective Analysis.

OBJECTIVE: The aim of this study was to understand the demographic, clinical characteristics, and effectiveness of early inpatient rehabilitation of post-COVID survivors. DESIGN: A single-center retrospective chart review analysis of 100 patients admitted to a newly created acute COVID rehabilitation unit (CORE+) from April to December 2020 was conducted. RESULTS: The demographic and clinical characteristics and complications of 100 post-COVID patients were reviewed. Functional outcomes of GG Self-care and Mobility Activities Items (Section GG0130 and GG0170) of the Centers for Medicare & Medicaid Services of the Inpatient Rehabilitation Facility Patient Assessment Instrument (Version 3.0) at admission and discharge, prevalence of oxygen requirement, the need for cognitive and neuropsychology support by discharge, and dispositions after completion of inpatient rehabilitation facility stay were analyzed. The functional outcomes of 59 primary pulmonary manifestations of COVID patients were further analyzed based on the presence of intensive care unit stay before transfer to the COVID rehabilitation unit. Most patients demonstrated significant functional gains after completion of inpatient rehabilitation facility stay; however, a considerable number of patients continued to require cognitive support by discharge. CONCLUSION: The data suggested the benefit of early rehabilitation for hospitalized post-COVID patients. Services need to be geared to include patients' cognitive deficits.

International Recommendations to Manage Poststroke Equinovarus Foot Deformity Validated by a Panel of Experts Using Delphi.

OBJECTIVE: To establish international recommendations for the management of spastic equinovarus foot deformity. DESIGN: Delphi method. SETTING: International study. PARTICIPANTS: A total of 24 international experts (N=24) in neuro-orthopedic deformities, from different specialties (Physical and Rehabilitation Medicine physicians, neurologists, geriatricians, orthopedic surgeons, neurosurgeons, plastic surgeons). INTERVENTIONS: Experts answered 3 rounds of questions related to important aspects of diagnosis, assessment, and treatment of spastic equinovarus foot deformity. MAIN OUTCOME MEASURES: A consensus was established when at least 80% of experts agreed on a statement RESULTS: A total of 52 items reached consensus. Experts recommend assessing effect of the deformity on functional activities before treatment. Before treatment, it is crucial to differentiate spastic muscle overactivity from soft tissue contractures, identify which muscles are involved in the deformity, and evaluate the activity of antagonist muscles. Motor nerve blocks, 2-dimensional video analysis, and radiologic examinations are often required to complement a clinical examination. The treatment of equinovarus foot depends on the correctability of the deformity and the patient's ability to stand or walk. The preoperative assessment should include an interdisciplinary consultation that must finalize a formal agreement between physicians and the patient, which will define personalized attainable goals before surgery. CONCLUSION: The establishment of guidelines on managing equinovarus foot will help physicians and surgeons, specialists, and nonspecialists to diagnoses and assess the deformity and direct patients to a network of experts to optimize patient functional recovery and improve their autonomy.

An impairment-specific hip exoskeleton assistance for gait training in subjects with acquired brain injury: a feasibility study.

This study was designed to investigate the feasibility and the potential effects on walking performance of a short gait training with a novel impairment-specific hip assistance (iHA) through a bilateral active pelvis orthosis (APO) in patients with acquired brain injury (ABI). Fourteen subjects capable of independent gait and exhibiting mild-to-moderate gait deficits, due to an ABI, were enrolled. Subjects presenting deficit in hip flexion and/or extension were included and divided into two groups based on the presence (group A, n = 6) or absence (group B, n = 8) of knee hyperextension during stance phase of walking. Two iHA-based profiles were developed for the groups. The protocol included two overground gait training sessions using APO, and two evaluation sessions, pre and post training. Primary outcomes were pre vs. post-training walking distance and steady-state speed in the 6-min walking test. Secondary outcomes were self-selected speed, joint kinematics and kinetics, gait symmetry and forward propulsion, assessed through 3D gait analysis. Following the training, study participants significantly increased the walked distance and average steady-state speed in the 6-min walking tests, both when walking with and without the APO. The increased walked distance surpassed the minimal clinically important difference for groups A and B, (respectively, 42 and 57 m > 34 m). In group A, five out of six subjects had decreased knee hyperextension at the post-training session (on average the peak of the knee extension angle was reduced by 36%). Knee flexion during swing phase increased, by 16% and 31%, for A and B groups respectively. Two-day gait training with APO providing iHA was effective and safe in improving walking performance and knee kinematics in ABI survivors. These preliminary findings suggest that this strategy may be viable for subject-specific post-ABI gait rehabilitation.

Impact of Vaccination in the Rate of COVID-19 Staff Infection in an Acute Inpatient Rehabilitation Facility.

ABSTRACT: This brief report summarizes the comparative experience of an inpatient rehabilitation facility dealing with two episodes of COVID-19 infection, one before and one after the availability of vaccination, which was deployed to staff. The experience exemplifies the high rate of infection and potential for asymptomatic presentation of COVID-19 as well as the protective advantage of the vaccine for healthcare workers in this report. With a significant reduction in the rate of infection, from nearly 30% before vaccination to only 2.5% after vaccination. The data presented should serve as an encouragement for vaccination across all populations.

AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol.

INTRODUCTION: The safety and efficacy of both abobotulinumtoxinA and onabotulinumtoxinA for upper limb spasticity are well established, but head-to-head comparisons are lacking. METHODS: DIRECTION is an international, randomized, double-blind, crossover study comparing the safety and efficacy of abobotulinumtoxinA with onabotulinumtoxinA in the management of upper limb spasticity at doses at or near maximum recommended in product labelling. Participants (18-75 years) will be randomized (1:1) to either one cycle of abobotulinumtoxinA (900U) followed by onabotulinumtoxinA (360U) or vice versa. To maintain blinding, a fixed volume (3.6 ml) will be injected into the target upper limb muscles (four wrist and finger flexors and biceps brachii). The second treatment cycle will begin at Week 12 if retreatment criteria are fulfilled, and if not, they will be reassessed every 4 weeks until they meet retreatment parameters. PLANNED OUTCOMES: The primary hypothesis is that there is comparable safety between products; non-inferiority will be tested based on treatment-emergent adverse event (TEAE) rates from injection to Week 12. A secondary hypothesis is that abobotulinumtoxinA has longer duration of effect than onabotulinumtoxinA. This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment. TRIAL REGISTRATION: EudraCT ( http://eudract.ema.europa.eu ): 2021-000161-32 and Clinicaltrials.gov ( http://clinicaltrials.gov ): NCT04936542. Overview of the study protocol by the principal investigator (MP4 185265 KB).

Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study.

OBJECTIVE: To identify baseline characteristics and treatment-related variables that affect adherence to onabotulinumtoxinA treatment from the Adult Spasticity International Registry (ASPIRE) study. DESIGN: Prospective, observational registry (NCT01930786). SETTING: International clinical sites. PARTICIPANTS: Adults with spasticity (N=730). INTERVENTIONS: OnabotulinumtoxinA at clinician's discretion. MAIN OUTCOME MEASURES: Clinically meaningful thresholds used for treatment adherent (≥3 treatment sessions during 2-year study) and nonadherent (≤2 sessions). Data analyzed using logistic regression and presented as odds ratios (ORs) with 95% confidence intervals (CIs). Treatment-related variables assessed at sessions 1 and 2 only. RESULTS: Of the total population, 523 patients (71.6%) were treatment adherent with 5.3±1.6 sessions and 207 (28.4%) were nonadherent with 1.5±0.5 sessions. In the final model (n=626/730), 522 patients (83.4%) were treatment adherent and 104 (16.6%) were nonadherent. Baseline characteristics associated with adherence: treated in Europe (OR=1.84; CI, 1.06-3.21; P=.030) and use of orthotics (OR=1.88; CI, 1.15-3.08; P=.012). Baseline characteristics associated with nonadherence: history of diplopia (OR=0.28; CI, 0.09-0.89; P=.031) and use of assistive devices (OR=0.51; CI, 0.29-0.90; P=.021). Treatment-related variables associated with nonadherence: treatment interval ≥15 weeks (OR=0.43; CI, 0.26-0.72; P=.001) and clinician dissatisfaction with onabotulinumtoxinA to manage pain (OR=0.18; CI, 0.05-0.69; P=.012). Of the population with stroke (n=411), 288 patients (70.1%) were treatment adherent with 5.3±1.6 sessions and 123 (29.9%) were nonadherent with 1.5±0.5 session. In the final stroke model (n=346/411), 288 patients (83.2%) were treatment adherent and 58 (16.8%) were nonadherent. Baseline characteristics associated with adherence: treated in Europe (OR=2.99; CI, 1.39-6.44; P=.005) and use of orthotics (OR=3.18; CI, 1.57-6.45; P=.001). Treatment-related variables associated with nonadherence: treatment interval ≥15 weeks (OR=0.42; CI, 0.21-0.83; P=.013) and moderate/severe disability on upper limb Disability Assessment Scale pain subscale (OR=0.40; CI, 0.19-0.83; P=.015). CONCLUSIONS: These ASPIRE analyses demonstrate real-world patient and clinical variables that affect adherence to onabotulinumtoxinA and provide insights to help optimize management strategies to improve patient care.

The Codivilla spring: from then to now and beyond.

The ankle-foot-orthosis (AFO), originally called Codivilla spring, is an orthotic device prescribed to the patients with foot drop due to neurological diseases in order to control the range of motion of the ankle joint and to compensate the muscle weakness/spasticity, thus optimizing the gait function. In this paper, a historical revision of the most known and used AFO worldwide from the origin of its name and the first applications at the Rizzoli Orthopedic Institute to the most advanced solutions in use today is covered. Through the critical analysis of the historical documents available, the paper reports on the controversy about the true inventor of the Codivilla spring during the first decades of the XX century. In terms of their design and indications, adult and child AFOs are presented. Finally, possible approaches for the selection of the correct orthosis and the individual prescription are discussed in order to manage specific mechanical neuromuscular deficiencies of the subject's ankle-foot complex, optimizing walking efficiency.

Research and Industry Partnerships in Physiatry.

ABSTRACT: The Association of Academic Physiatrists, the home of academic physiatry, is interested in advancing industry partnerships in research among academic physiatrists. There are limited existing resources that outline opportunities for academic physiatrists in engaging the translational research continuum through industry partnerships and the skill sets that academic physiatrists need to successfully navigate these partnerships. In 2019, then President of the Association of Academic Physiatrists, John Chae, MD, ME, assembled a group of interested physician-scientists in physical medicine and rehabilitation to form the Research and Industry Partnerships Task Force to address this problem. The Task Force implemented a live educational session titled "Collaborating with industry" at Physiatry '19, the Annual Meeting of the Association of Academic Physiatrists held in Puerto Rico. To extend the reach of this valuable information, the Task Force is creating resources that can be easily distributed and accessed by all physiatrists. The goal of this white paper is to provide a roadmap to help academic physiatrists begin to navigate the field of academia-industry relationships with the ultimate goal of accelerating discovery for the benefit of physiatry and rehabilitation patients.

A Comparison of the Armeo to Tabletop-assisted Therapy Exercises as Supplemental Interventions in Acute Stroke Rehabilitation: A Randomized Single Blind Study.

OBJECTIVES: To evaluate the feasibility of an additional therapeutic upper limb exercise (ULE) intervention in early phase post-stroke rehabilitation and to assess outcomes of therapy using the Armeo Spring (ARMEO) versus Therapist-assisted Table Top (TAT) interventions. DESIGN: Randomized, single-blind trial. SETTING: Stroke acute inpatient rehabilitation unit. PARTICIPANTS: Forty-five participants early after first stroke, Fugl-Meyer Assessment (FMA) score >8, Modified Ashworth score (MAS) of <3. INTERVENTIONS: Participants were randomized to TAT or ARMEO ULE in addition to the required 3 hours of 1:1 standard of care provided in an inpatient rehabilitation facility (IRF). MAIN OUTCOME MEASURES: Completed number of treatments; withdrawals; serious/adverse events; Functional Independence Measure (FIM) motor; FIM efficiency; FMA; MAS; elbow active (A) and passive (P) range of motion (ROM); and therapist effort measured by the Modified Borg Rating of Perceived Exertion Scale (RPE). RESULTS: Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (P = .585, .962, partial n2 = .001, .001, respectively). There were no statistically significant differences in post-intervention MAS elbow flexion and extension (P = .332, .252, partial n2 = .009, .007, respectively) and A/P ROM elbow extension between training groups (P = .841, .731, partial n2 = .001, .003, respectively). There was a statistically significant difference in post-intervention A/P ROM elbow flexion between groups (P = .031, .018, partial n2 = .123, .146). Post-intervention RPE did not show any statistically significant differences between the training groups (P = .128, partial n2 = .063). Total elbow range showed larger adjusted mean gains for the ARMEO. No serious adverse events were reported. CONCLUSIONS: This study demonstrates that additional therapeutic ULE in the early phase of post-stroke inpatient rehabilitation is feasible and that both interventions showed positive changes in selected outcomes.

Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity.

INTRODUCTION: OnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals. OBJECTIVE: To explore real-world onabotulinumtoxinA utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study. DESIGN: Two-year, multicenter, prospective, observational registry (NCT01930786). SETTING: Fifty-four international clinical sites. PATIENTS: Adults (naïve or non-naïve to botulinum toxin[s] treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome. INTERVENTIONS: OnabotulinumtoxinA administered at the clinician's discretion. MAIN OUTCOME MEASURES: OnabotulinumtoxinA treatment utilization, clinician- and patient-reported satisfaction. RESULTS: In ASPIRE, 530 patients received ≥1 onabotulinumtoxinA treatment for lower limb spasticity (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot was treated most often (80.9% of patients), followed by flexed knee (26.0%), stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was most commonly used for injection localization (≥41.1% of treatment sessions). Despite low patient response on the satisfaction questionnaire, clinicians (94.6% of treatment sessions) and patients (84.5%) reported satisfaction/extreme satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. These data should be interpreted with care. Twenty-one adverse events (AEs) in 18 patients (3.4%) were considered treatment-related. Sixty-seven patients (12.6%) reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered treatment-related. No new safety signals were identified. CONCLUSIONS: ASPIRE provides long-term observational data on the treatment of lower limb spasticity with onabotulinumtoxinA. Real-world data from this primary analysis can help to guide the clinical use of onabotulinumtoxinA to improve spasticity management.

The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury.

BACKGROUND: Botulinum toxin (BoNT) injections were shown to improve muscle tone of limbs in patients with spasticity. However, limited data are available regarding the effects of repeated BoNT injections on walking ability. OBJECTIVE: To assess changes in walking velocity (WV), step length, and cadence under different test conditions after repeated treatment with abobotulinumtoxinA (aboBoNT-A; Dysport) in spastic lower limb muscles. DESIGN: Secondary analysis of an open-label, multiple-cycle extension (National Clinical Trials number NCT01251367) to a phase III, double-blind, randomized, placebo-controlled, single-treatment cycle study, in adults with chronic hemiparesis (NCT01249404). SETTING: Fifty-two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States. PATIENTS: 352 Ambulatory adults (18-80 years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1 to 0.8 m/s. INTERVENTIONS: Up to four aboBoNT-A treatment cycles, administered to spastic lower limb muscles. MAIN OUTCOME MEASUREMENTS: Changes from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/minutes). RESULTS: At Week 12 after four injections, WV improved by 0.08 to 0.10 m/s, step length by 0.03 to 0.04 m/step, and cadence by 3.9 to 6.2 steps/minutes depending on test condition (all P < .0001 to .0003 vs baseline). More patients (7% to 17%) became unlimited community ambulators (WV ≥0.8 m/s) across test conditions compared with baseline, with 39% of 151 patients classified as unlimited community ambulators in at least one test condition and 17% in all four test conditions. CONCLUSIONS: Clinically meaningful and statistically significant improvements in WV, step length, and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.