Gerard E. Francisco

Botulinum toxin in upper limb spasticity after acquired brain injury: A randomized trial comparing dilution techniques

Francisco GE, Boake C, Vaughn A: Botulinum toxin in upper limb spasticity after acquired brain injury: A randomized trial comparing dilution techniques. Am J Phys Med Rehabil 2002;81:355–363. Objective To compare the efficacy of two different volume preparations of the same dose of botulinum toxin-A in relieving spasticity in wrist and finger flexors secondary to acquired brain injury. Design Thirteen adult patients who had modified Ashworth scale scores of 3 for both wrist and finger flexors were included in this randomized, controlled trial. Wrist and finger flexors were each injected. Blinded modified Ashworth scale ratings of wrist and finger flexor spasticity were measured. Results Spasticity in both muscles decreased significantly in both treatment groups. However, the high-volume and low-volume groups did not differ significantly in spasticity reduction. Conclusions Because this preliminary study found no difference in spasticity reduction between high- and low-volume preparations of a 60-unit dose of botulinum toxin-A, a larger-sample study seems warranted to compare the efficacy of high-volume and low-volume preparations.

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study

AbstractBackgroundStroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors.MethodsH2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient’s perception about the easy of use of the device.ResultsThree stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients.ConclusionsThe developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals. Trial registration: This study was registered at ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT02114450).

The H2 robotic exoskeleton for gait rehabilitation after stroke

AbstractBackgroundStroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors.MethodsH2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient’s perception about the easy of use of the device.ResultsThree stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients.ConclusionsThe developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals. Trial registration: This study was registered at ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT02114450).

Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study.

OBJECTIVE To explore whether intrathecal baclofen (ITB) therapy improves ambulation in stroke survivors. DESIGN Case series. SETTING Tertiary care center. PARTICIPANTS Ten adults with poststroke hemiparesis who were ambulatory at the time of pump implantation. INTERVENTIONS Implantation of ITB pump after inadequate control of spasticity with other interventions. Time from stroke onset to implantation averaged 28.6 months (range, 9-55mo). MAIN OUTCOME MEASURES Customary walking speed was measured from the time required to walk 50ft (15m) at a self-selected pace. Evaluators rated spastic hypertonia and functional mobility. RESULTS Statistically significant improvements occurred in walking speed, functional mobility ratings, and spasticity (P<.05) at a follow-up interval that averaged 8.9 months. Mean walking speed over 50ft improved from 36.6 to 52cm/s. Mean Modified Ashworth Scale scores in the muscles of the affected lower limb improved from 2.0 to 0.4. Normal muscle strength (5/5) was preserved in the unaffected limbs. CONCLUSIONS This preliminary study suggests that ITB therapy, in combination with physical therapy, may improve walking speed and functional mobility in ambulatory individuals with poststroke spastic hemiplegia.

Effect of a Foot-Drop Stimulator and Ankle–Foot Orthosis on Walking Performance After Stroke A Multicenter Randomized Controlled Trial

Background. Studies have demonstrated the efficacy of functional electrical stimulation in the management of foot drop after stroke. Objective. To compare changes in walking performance with the WalkAide (WA) foot-drop stimulator and a conventional ankle–foot orthosis (AFO). Methods. Individuals with stroke within the previous 12 months and residual foot drop were enrolled in a multicenter, randomized controlled, crossover trial. Subjects were assigned to 1 of 3 parallel arms for 12 weeks (6 weeks/device): arm 1 (WA–AFO), n = 38; arm 2 (AFO–WA), n = 31; arm 3 (AFO–AFO), n = 24. Primary outcomes were walking speed and Physiological Cost Index for the Figure-of-8 walking test. Secondary measures included 10-m walking speed and perceived safety during this test, general mobility, and device preference for arms 1 and 2 for continued use. Walking tests were performed with (On) and without a device (Off) at 0, 3, 6, 9, and 12 weeks. Results. Both WA and AFO had significant orthotic (On–Off difference), therapeutic (change over time when Off), and combined (change over time On vs baseline Off) effects on walking speed. An AFO also had a significant orthotic effect on Physiological Cost Index. The WA had a higher, but not significantly different therapeutic effect on speed than an AFO, whereas an AFO had a greater orthotic effect than the WA (significant at 12 weeks). Combined effects on speed after 6 weeks did not differ between devices. Users felt as safe with the WA as with an AFO, but significantly more users preferred the WA. Conclusions. Both devices produce equivalent functional gains.

Efficacy of early use of intrathecal baclofen therapy for treating spastic hypertonia due to acquired brain injury.

Objective. To determine the efficacy and safety of early (<1 year post-disease onset) use of intrathecal baclofen (ITB). Design. Consecutive case series of 14 individuals with spastic hypertonia due to trauma (5), anoxia (6) and stroke (3). Main outcome measures. Modified Ashworth (MAS) and Disability Rating (DRS) scales. Interventions. ITB pump placement within 1 year of onset, after inadequate response to other previous treatment modalities. Results. At follow-up after ITB pump implantation (mean = 13.9 months; mean daily dose = 591.5 µg per day), mean MAS scores improved from baseline by 1.0 and 2.1 points in the upper and lower limbs, respectively. DRS scores did not change significantly. Functional gains included decreased pain and improved gait speed and motor skills. The only complication was spinal leak in one subject. Conclusions. ITB therapy within 1 year of onset of acquired brain injury appears effective and safe in decreasing spastic hypertonia and does not appear to adversely affect recovery.

Bruxism after brain injury: Successful treatment with botulinum toxin-A

Bruxism, the rhythmic grinding of teeth--usually during sleep--is not an infrequent complication of traumatic brain injury. Its prevalence in the general population is 21%, but its incidence after brain injury is unknown. Untreated, bruxism causes masseter hypertrophy, headache, temporomandibular joint destruction, and total dental wear. We report a case of complete resolution of postanoxic bruxism after treatment with botulinum toxin-A (BTX-A). The patient was a 28-year-old man with no history of bruxism who sustained an anoxic brain injury secondary to cardiac arrest of unknown etiology. On admission to our rehabilitation unit 2 months after the injury, the patient presented with severe bruxism and heavy dental wear. The patient was injected with a total of 200 units of BTX-A to each masseter and temporalis. There was total resolution of bruxism 2 days after injection, with no complications. On follow-up 3 months after injection, the patient remained free of bruxism. We propose that botulinum toxin be considered as a treatment for bruxism secondary to anoxic brain injury. Further studies regarding muscle selection and medication dosage are warranted to elucidate the toxins efficacy in this condition.

Poststroke chronic disease management: towards improved identification and interventions for poststroke spasticity‐related complications

This paper represents the opinion of a group of researchers and clinicians with an established interest in poststroke care and is based on the recognised need for long-term care following stroke, especially in view of the global increase of disability due to stroke. Among the more frequent long-term complications following stroke are spasticity-related disabilities. Although spasticity alone occurs in up to 60% of stroke survivors, disabling spasticity affects only 4–10%. Spasticity further interferes with important functions of daily life when it occurs in association with pain, motor impairment, and overall declines of cognitive and neurological function. It is proposed that the aftermath of stroke be considered a chronic disease requiring a multifactorial and multilevel approach. There are, however, knowledge gaps related to the prediction and recognition of poststroke disability. Interventions to prevent or minimise such disabilities require further development and evaluation. Poststroke spasticity research should focus on reducing disability and be considered as part of a continuum of chronic care requirements and should be recognised as a part of a comprehensive poststroke disease management programme.

Dynamic splinting after treatment with botulinum toxin type-A: A randomized controlled pilot study

IntroductionOver 1.5 million Americans are diagnosed with a stroke each year, and excessive flexion or extension (hypertonia) of upper extremity joints are common secondary conditions. The purpose of this study was to compare the efficacy of botulinum toxin type-A and manual therapy, with the adjunct treatment of dynamic splinting on range of motion, spasticity, and elbow flexor hypertonia, in a randomized trial.MethodsThirty-six subjects were recruited for this pilot study and all exhibited hypertonia in elbow flexion. Six patients were excluded due to noncompliance. Testing was done with pre/post active range of motion in elbow extension, and the Modified Ashworth Scale (extension) for spasticity. All patients received the current standard of care: botulinum toxin type-A injections and manual therapy. Experimental patients were randomly assigned adjunct treatment with Elbow Extension Dynasplint®.ResultsThirty patients completed the study (mean age [SD] 52±17 years). The percentage of change in active range of motion in elbow extension was greater for the experimental than for control subjects (33.5% vs. 18.7%). The Modified Ashworth Scale (extension) scores showed comparable changes of a mean 9.3% improvement for experimental versus 8.6% for the control subjects.ConclusionThis study confirmed the efficacy of botulinum toxin type-A in tone management and occupational therapy in contracture reduction. It also showed the value of dynamic splinting in maintaining gains in range of motion.

Spasticity, weakness, force variability, and sustained spontaneous motor unit discharges of resting spastic–paretic biceps brachii muscles in chronic stroke

Introduction: The purpose of our study was to examine relations among spasticity, weakness, force variability, and sustained spontaneous motor unit discharges in spastic–paretic biceps brachii muscles in chronic stroke. Methods: Ten chronic stroke subjects produced submaximal isometric elbow flexion force on impaired and non‐impaired sides. Intramuscular EMG (iEMG) was recorded from biceps and triceps brachii muscles. Results: We observed sustained spontaneous motor unit discharges in resting biceps on iEMG. Spontaneous discharges increased after voluntary activation only on the impaired side. The impaired side had greater matching errors and greater fluctuations in isometric force. Spontaneous discharges were not related functionally to spasticity, force variability, or weakness. However, greater strength on the impaired side correlated with less force variability. Conclusion: Weakness rather than spasticity is a main factor interfering with voluntary force control in paretic–spastic biceps brachii muscles in chronic stroke. Muscle Nerve, 2013