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Efficacy of IncobotulinumtoxinA in Treatment of Lower Limb Spasticity, Including Pes Equinovarus in Adults
Research Posters robotic exoskeleton training has the potential to facilitate recovery for individuals with SCI. Key Words: Gait, Spinal Cord Injuries, Robotics Disclosures: None. Research Poster 305109 Effects of Structured Exercise and Disease Severity on Mobility Outcomes in Individuals with Multiple Sclerosis Cassandra Herman (UAB/Lakeshore Research Collaborative), Alex Yates, Yumi Kim, James Rimmer Research Objectives: To determine the effect of disease severity on mobility outcomes after participation in a structured exercise program for individuals with multiple sclerosis (MS). Design: A 12-week randomized controlled trial. Participants were randomly assigned to movement-to-music (M2M) or adapted yoga (AY). Data was collected at baseline and post-intervention. Setting: Community-based fitness facility for individuals with disabilities and chronic health conditions. Participants: Individuals ages 18 to 65 with mild (nZ27) to moderate (nZ14) MS indicated by Patient Determined Disease Steps [PDDS] score. Mild and moderate disease was defined as PDDS 0-2 and 3-6 respectively. Interventions: Participants in both intervention groups received a structured exercise program three 60 minute exercise sessions per week for 12 weeks. The M2M arm received a rhythmic movement program structured to target range of motion, muscle strength, aerobic endurance and balance. The AY arm completed a progressive yoga curriculum of based in Hathya yoga which provided for the use of props to complete each pose. Main Outcome Measure(s): Walking velocity, timed up and go (TUG) test, five-time sit to stand (FTSST), and 6-minute walk test (6MWT). Results: Significant within group increases were seen in gait velocity was seen in both mild (pZ0.01) and moderate (pZ0.006) MS. Significant within group increases were also seen in those with mild MS for the TUG (pZ0.003), FTSST (pZ0.038) and 6MWT (pZ0.038). Between group differences were seen for FTSST (0.047) indicating greater disease severity lead to greater gains in FTSST. Conclusion/Discussion: Preliminary findings indicate that participation in a structured exercise program has a positive effect on mobility outcomes for individuals with mild MS. Disease severity may act as an effect modifier for mobility outcomes leading to greater gains in functional strength for those with moderate MS. Key Words: Multiple Sclerosis, Disease Severity, Mobility, Exercise Disclosures: None. Research Poster 303176 Efficacy of Exercise Protocol for Cancer Patients: Outcomes for Cardiopulmonary Performance and Fatigue Nancy Hutchison (Courage Kenny Rehabilitation Institute), Nikita Deval, Stacey Rabusch, Thomas Kelley, Holly Rich, Nancy Flinn, Nilanjana Banerji Research Objectives: To describe the clinical population of patients with cancer who are referred to the Courage Kenny Cancer Rehabilitation Program (CK Program) and evaluate the efficacy of the program’s therapy protocol in improving cardiopulmonary performance and cancer-related fatigue. Design: Retrospective Chart Review of 144 cases between January 2014 and June 2016. Setting: Sample of outpatients who met inclusion/exclusion criteria from the CK Program. Participants: One-hundred forty adults diagnosed with cancer, referred to the CK Program from a variety of referral sources including specialties of PM&R, oncology, and surgery. Interventions: Physical therapists provided and supervised initiation of individualized programs of strengthening and cardiovascular exercise.
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e63 Main Outcome Measure(s): The primary outcome measure compared change in discharge to baseline of the 6 Minute Walk (6MWT) scores to evaluate cardiopulmonary performance. The secondary outcomes measured changes in discharge and baseline scores of cancer-related fatigue and general pain, both measured by patient self-report using a Visual Analog Scale. Results: One-hundred forty-four cases, involving 140 patients, were included in the study. The Wilcoxon Signed Ranks Test was used to determine statistical significance. 6MWT values were significantly higher at discharge (MedianZ536.7) than at baseline (MedianZ456.1), (zZ -9.43, p < .000, rZ-.57). Eighty-eight percent of cases showed improvement and 58% of cases had a change on the 6MWT that met the threshold for Minimal Clinically Important Difference. The interference of debility with daily life, shown via fatigue (zZ-7.00, p < .000, rZ -.45) and pain (zZ-3.22, p < .001, rZ-.21) also indicated improvement. Conclusion/Discussion: The results indicate the CK Program yields significant improvement in cardiovascular fitness and self-reported fatigue and pain, in people with a history of cancer. Personalized fitness programs for individuals recovering from cancer treatment should be a standard component of cancer intervention. Key Words: Exercise, Cardiopulmonary Performance, Cancer-Related Fatigue, Six Minute Walk Test (6MWT), Debility Disclosures: None.
Research Poster 305113 Efficacy of IncobotulinumtoxinA in Treatment of Lower Limb Spasticity, Including Pes Equinovarus in Adults John McGuire (Medical College of Wisconsin), Jo¨rg Wissel, Djamel Bensmail, Astrid Scheschonka, Birgit Flatau-Baque´, David Simpson Research Objectives: Botulinum toxin A formulations are established treatments for the treatment of upper limb (UL) spasticity. The objective of this post-hoc analysis was to assess the effectiveness of incobotulinumtoxinA for treating lower limb (LL) spasticity including pes equinovarus. Design: TOWER (NCT01603459) was a prospective, single-arm, dosetitration study. Setting: Thirty sites in 8 countries (United States, Canada, Germany, Norway, Spain, Italy, France, Portugal). Participants: 155 adult subjects (18-80 years) with UL and LL spasticity. Interventions: Escalating fixed total doses of incobotulinumtoxinA: 400, 600, and 600-800U in respective cycles. Main Outcome Measure(s): Muscle tone (Ashworth Scale [AS]); AS responder rates (defined as patients with 1 point improvement at 4weeks); Resistance to Passive Movement Scale (REPAS). Results: IncobotulinumtoxinA was administered to 109 subjects for LL spasticity and 100 subjects for pes equinovarus during the first cycle; the mean (SD) dose for pes equinovarus was 166.394.9U. At 4-weeks postinjection, the mean AS score improvement ( SD) in ankle joint was 0.630.76 in subjects treated for pes equinovarus and 0.160.63 in subjects not treated for pes equinovarus. The dose administered significantly affected pes equinovarus improvement as assessed by AS (PZ0.0096; multiple regression analysis adjusting for AS baseline). Fifty-five percent of treated subjects were considered AS responders, compared with 12.7% of untreated subjects (P < 0.0001; Mantel-Haenszel Chi-Square test). At 4-weeks postinjection, mean improvement ( SD) in REPAS LL scores from baseline was 1.62.0 in subjects with LL treatment and 0.31.5 in subjects without. Multiple regression analysis on LL REPAS baseline value and LL dose demonstrated a significant dose dependence (PZ0.0022). Conclusion/Discussion: Results support the safety and effectiveness of incobotulinumtoxinA for the treatment of LL spasticity and pes equinovarus. Key Words: Incobotulinumtoxina, Spasticity, Botulinum Toxin Disclosures: None.
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e63 Main Outcome Measure(s): The primary outcome measure compared change in discharge to baseline of the 6 Minute Walk (6MWT) scores to evaluate cardiopulmonary performance. The secondary outcomes measured changes in discharge and baseline scores of cancer-related fatigue and general pain, both measured by patient self-report using a Visual Analog Scale. Results: One-hundred forty-four cases, involving 140 patients, were included in the study. The Wilcoxon Signed Ranks Test was used to determine statistical significance. 6MWT values were significantly higher at discharge (MedianZ536.7) than at baseline (MedianZ456.1), (zZ -9.43, p < .000, rZ-.57). Eighty-eight percent of cases showed improvement and 58% of cases had a change on the 6MWT that met the threshold for Minimal Clinically Important Difference. The interference of debility with daily life, shown via fatigue (zZ-7.00, p < .000, rZ -.45) and pain (zZ-3.22, p < .001, rZ-.21) also indicated improvement. Conclusion/Discussion: The results indicate the CK Program yields significant improvement in cardiovascular fitness and self-reported fatigue and pain, in people with a history of cancer. Personalized fitness programs for individuals recovering from cancer treatment should be a standard component of cancer intervention. Key Words: Exercise, Cardiopulmonary Performance, Cancer-Related Fatigue, Six Minute Walk Test (6MWT), Debility Disclosures: None.
Research Poster 305113 Efficacy of IncobotulinumtoxinA in Treatment of Lower Limb Spasticity, Including Pes Equinovarus in Adults John McGuire (Medical College of Wisconsin), Jo¨rg Wissel, Djamel Bensmail, Astrid Scheschonka, Birgit Flatau-Baque´, David Simpson Research Objectives: Botulinum toxin A formulations are established treatments for the treatment of upper limb (UL) spasticity. The objective of this post-hoc analysis was to assess the effectiveness of incobotulinumtoxinA for treating lower limb (LL) spasticity including pes equinovarus. Design: TOWER (NCT01603459) was a prospective, single-arm, dosetitration study. Setting: Thirty sites in 8 countries (United States, Canada, Germany, Norway, Spain, Italy, France, Portugal). Participants: 155 adult subjects (18-80 years) with UL and LL spasticity. Interventions: Escalating fixed total doses of incobotulinumtoxinA: 400, 600, and 600-800U in respective cycles. Main Outcome Measure(s): Muscle tone (Ashworth Scale [AS]); AS responder rates (defined as patients with 1 point improvement at 4weeks); Resistance to Passive Movement Scale (REPAS). Results: IncobotulinumtoxinA was administered to 109 subjects for LL spasticity and 100 subjects for pes equinovarus during the first cycle; the mean (SD) dose for pes equinovarus was 166.394.9U. At 4-weeks postinjection, the mean AS score improvement ( SD) in ankle joint was 0.630.76 in subjects treated for pes equinovarus and 0.160.63 in subjects not treated for pes equinovarus. The dose administered significantly affected pes equinovarus improvement as assessed by AS (PZ0.0096; multiple regression analysis adjusting for AS baseline). Fifty-five percent of treated subjects were considered AS responders, compared with 12.7% of untreated subjects (P < 0.0001; Mantel-Haenszel Chi-Square test). At 4-weeks postinjection, mean improvement ( SD) in REPAS LL scores from baseline was 1.62.0 in subjects with LL treatment and 0.31.5 in subjects without. Multiple regression analysis on LL REPAS baseline value and LL dose demonstrated a significant dose dependence (PZ0.0022). Conclusion/Discussion: Results support the safety and effectiveness of incobotulinumtoxinA for the treatment of LL spasticity and pes equinovarus. Key Words: Incobotulinumtoxina, Spasticity, Botulinum Toxin Disclosures: None.