Validity, Intra-Rater Reliability and Normative Data of the Neuroflexor™ Device to Measure Spasticity of the Ankle Plantar Flexors after Stroke.

OBJECTIVE: Quantification of lower limb spasticity after stroke and the differentiation of neural from passive muscle resistance remain key clinical challenges. The aim of this study was to validate the novel NeuroFlexor foot module, to assess the intrarater reliability of measurements and to identify normative cut-off values. METHODS: Fifteen patients with chronic stroke with clinical history of spasticity and 18 healthy subjects were examined with the NeuroFlexor foot module at controlled velocities. Elastic, viscous and neural components of passive dorsiflexion resistance were quantified (in Newton, N). The neural component, reflecting stretch reflex mediated resistance, was validated against electromyography activity. A test-retest design with a 2-way random effects model permitted study of intra-rater reliability. Finally, data from 73 healthy subjects were used to establish cutoff values according to mean + 3 standard deviations and receiver operating characteristic curve analysis. RESULTS: The neural component was higher in stroke patients, increased with stretch velocity and correlated with electromyography amplitude. Reliability was high for the neural component (intraclass correlation coefficient model 2.1 (ICC2,1) ≥ 0.903) and good for the elastic component (ICC2,1 ≥ 0.898). Cutoff values were identified, and all patients with neural component above the limit presented pathological electromyography amplitude (area under the curve (AUC) = 1.00, sensitivity = 100%, specificity = 100%). CONCLUSION: The NeuroFlexor may offer a clinically feasible and non-invasive way to objectively quantify lower limb spasticity.

Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity.

Background: The EXOPULSE Mollii method is an innovative full-body suit approach for non-invasive electrical stimulation, primarily designed to reduce disabling spasticity and improve motor function through the mechanism of reciprocal inhibition. This study aimed to evaluate the effectiveness of one session of stimulation with the EXOPULSE Mollii suit at different stimulation frequencies on objective signs of spasticity and clinical measures, and the subjective perceptions of the intervention. Methods: Twenty patients in the chronic phase after stroke were enrolled in a cross-over, double-blind controlled study. Electrical stimulation delivered through EXOPULSE Mollii was applied for 60 min at two active frequencies (20 and 30 Hz) and in OFF-settings (placebo) in a randomized order, every second day. Spasticity was assessed with controlled-velocity passive muscle stretches using the NeuroFlexor hand and foot modules. Surface electromyography (EMG) for characterizing flexor carpi radialis, medial gastrocnemius, and soleus muscles activation, Modified Ashworth Scale and range of motion were used as complementary tests. Finally, a questionnaire was used to assess the participants' perceptions of using the EXOPULSE Mollii suit. Results: At group level, analyses showed no significant effect of stimulation at any frequency on NeuroFlexor neural component (NC) and EMG amplitude in the upper or lower extremities (p > 0.35). Nevertheless, the effect was highly variable at the individual level, with eight patients exhibiting reduced NC (>1 N) in the upper extremity after stimulation at 30 Hz, 5 at 20 Hz and 3 in OFF settings. All these patients presented severe spasticity at baseline, i.e., NC > 8 N. Modified Ashworth ratings of spasticity and range of motion did not change significantly after stimulation at any frequency. Finally, 75% of participants reported an overall feeling of well-being during stimulation, with 25% patients describing a muscle-relaxing effect on the affected hand and/or foot at both 20 and 30 Hz. Conclusions: The 60 min of electrical stimulation with EXOPULSE Mollii suit did not reduce spasticity consistently in the upper and lower extremities in the chronic phase after stroke. Findings suggest a need for further studies in patients with severe spasticity after stroke including repeated stimulation sessions. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04076878, identifier: NCT04076878.

Recovery and Prediction of Bimanual Hand Use After Stroke.

OBJECTIVE: To determine similarities and differences in key predictors of recovery of bimanual hand use and unimanual motor impairment after stroke. METHOD: In this prospective longitudinal study, 89 patients with first-ever stroke with arm paresis were assessed at 3 weeks and 3 and 6 months after stroke onset. Bimanual activity performance was assessed with the Adult Assisting Hand Assessment Stroke (Ad-AHA), and unimanual motor impairment was assessed with the Fugl-Meyer Assessment (FMA). Candidate predictors included shoulder abduction and finger extension measured by the corresponding FMA items (FMA-SAFE; range 0-4) and sensory and cognitive impairment. MRI was used to measure weighted corticospinal tract lesion load (wCST-LL) and resting-state interhemispheric functional connectivity (FC). RESULTS: Initial Ad-AHA performance was poor but improved over time in all (mild-severe) impairment subgroups. Ad-AHA correlated with FMA at each time point (r > 0.88, p < 0.001), and recovery trajectories were similar. In patients with moderate to severe initial FMA, FMA-SAFE score was the strongest predictor of Ad-AHA outcome (R 2 = 0.81) and degree of recovery (R 2 = 0.64). Two-point discrimination explained additional variance in Ad-AHA outcome (R 2 = 0.05). Repeated analyses without FMA-SAFE score identified wCST-LL and cognitive impairment as additional predictors. A wCST-LL >5.5 cm3 strongly predicted low to minimal FMA/Ad-AHA recovery (≤10 and 20 points respectively, specificity = 0.91). FC explained some additional variance to FMA-SAFE score only in unimanual recovery. CONCLUSION: Although recovery of bimanual activity depends on the extent of corticospinal tract injury and initial sensory and cognitive impairments, FMA-SAFE score captures most of the variance explained by these mechanisms. FMA-SAFE score, a straightforward clinical measure, strongly predicts bimanual recovery. CLINICALTRIALSGOV IDENTIFIER: NCT02878304. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that the FMA-SAFE score predicts bimanual recovery after stroke.

Passive Mechanical Properties of Human Medial Gastrocnemius and Soleus Musculotendinous Unit.

The in vivo characterization of the passive mechanical properties of the human triceps surae musculotendinous unit is important for gaining a deeper understanding of the interactive responses of the tendon and muscle tissues to loading during passive stretching. This study sought to quantify a comprehensive set of passive muscle-tendon properties such as slack length, stiffness, and the stress-strain relationship using a combination of ultrasound imaging and a three-dimensional motion capture system in healthy adults. By measuring tendon length, the cross-section areas of the Achilles tendon subcompartments (i.e., medial gastrocnemius and soleus aspects), and the ankle torque simultaneously, the mechanical properties of each individual compartment can be specifically identified. We found that the medial gastrocnemius (GM) and soleus (SOL) aspects of the Achilles tendon have similar mechanical properties in terms of slack angle (GM: -10.96° ± 3.48°; SOL: -8.50° ± 4.03°), moment arm at 0° of ankle angle (GM: 30.35 ± 6.42 mm; SOL: 31.39 ± 6.42 mm), and stiffness (GM: 23.18 ± 13.46 Nmm-1; SOL: 31.57 ± 13.26 Nmm-1). However, maximal tendon stress in the GM was significantly less than that in SOL (GM: 2.96 ± 1.50 MPa; SOL: 4.90 ± 1.88 MPa, p = 0.024), largely due to the higher passive force observed in the soleus compartment (GM: 99.89 ± 39.50 N; SOL: 174.59 ± 79.54 N, p = 0.020). Moreover, the tendon contributed to more than half of the total muscle-tendon unit lengthening during the passive stretch. This unequal passive stress between the medial gastrocnemius and the soleus tendon might contribute to the asymmetrical loading and deformation of the Achilles tendon during motion reported in the literature. Such information is relevant to understanding the Achilles tendon function and loading profile in pathological populations in the future.

Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke.

BACKGROUND: Spasticity after lesions of central motor pathways may be disabling and there is a need for new, cost-effective treatment methods. One novel approach is offered by the electro-dress Mollii®, primarily designed to enhance reciprocal inhibition of spastic muscles by multifocal, transcutaneous antagonist stimulation. METHODS: The Mollii® suit was set individually for 20 participants living with spasticity and hemiplegia after stroke and used in the home setting for 6 weeks. Usability and perceived effects were monitored by weekly telephone interviews. Outcome was assessed by use of the NeuroFlexor™ method for quantification of the neural component (NC) of resistance to passive stretch (spasticity), and the modified Ashworth scale (MAS) for total resistance, Fugl-Meyer Assessment of motor recovery for sensorimotor function in upper (FM-UE) and lower extremities (FM-LE), activity performance with the Action Research Arm Test (ARAT), Berg balance scale, 10 m and 6 min walk tests, and perceived functioning with the Stroke Impact Scale. RESULTS: Compliance was high (mean 19.25 of 21 sessions). Perceived positive effects were reported by 60% and most commonly related to decreased muscle tone (n = 9), improved gait pattern function (n = 7) and voluntary movement in the upper extremity (n = 6). On a group level, the NC decreased significantly in the wrist flexors of the affected hand (p = 0.023) and significant improvements according to FM-UE (p = 0.000) and FM-LE (p = 0.003) were seen after the intervention. No significant difference was detected with MAS or assessed activity performance, except for the ARAT (p = 0.000). FM-UE score change correlated significantly and fairly with the perceived effect in the upper extremity (r 0.498 p = 0.025) and in the corresponding analysis for the FM-LE and perceived effect in the lower extremity (r = 0.469 p = 0.037). CONCLUSION: This study indicates that the Mollii® method is feasible when used in the home setting to decrease spasticity and improve sensorimotor function. The results may guide a larger controlled study combined with rehabilitation interventions to enhance effects on activity and participation domains. TRIAL REGISTRATION: NCT04076878 . Registered 2 September 2019 - Retrospectively registered.

Recovery and Prediction of Dynamic Precision Grip Force Control After Stroke.

Background and Purpose- Dexterous object manipulation, requiring generation and control of finger forces, is often impaired after stroke. This study aimed to describe recovery of precision grip force control after stroke and to determine clinical and imaging predictors of 6-month performance. Methods- Eighty first-ever stroke patients with varying degrees of upper limb weakness were evaluated at 3 weeks, 3 months, and 6 months after stroke. Twenty-three healthy individuals of comparable age were also studied. The Strength-Dexterity test was used to quantify index finger and thumb forces during compression of springs of varying length in a precision grip. The coordination between finger forces (CorrForce), along with Dexterity-score and Repeatability-score, was calculated. Anatomical magnetic resonance imaging was used to calculate weighted corticospinal tract lesion load (wCST-LL). Results- CorrForce, Dexterity-score, and Repeatability-score in the affected hand were dramatically lower at each time point compared with the less-affected hand and the control group, even in patients with mild motor impairment according to Fugl-Meyer assessment. Improved performance over time occurred in CorrForce and Dexterity-score but not in Repeatability-score. The Fugl-Meyer assessment hand subscale, sensory function, and wCST-LL best predicted CorrForce and Dexterity-score status at 6 months (R2=0.56 and 0.87, respectively). wCST-LL explained substantial variance in CorrForce (R2=0.34) and Dexterity-score (R2=0.50) at 6 months; two-point discrimination and Fugl-Meyer score accounted for considerable additional variance. Absence of recovery in CorrForce was predicted by wCST-LL >4 cc and in Dexterity-score by wCST-LL >6 cc. Conclusions- Findings highlight persisting deficits in the ability to grasp and control finger forces after stroke. wCST-LL was the strongest predictor of performance at 6 months, but early two-point discrimination and Fugl-Meyer score had substantial additional predictive value. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02878304.

In vivo muscle morphology comparison in post-stroke survivors using ultrasonography and diffusion tensor imaging.

Skeletal muscle architecture significantly influences the performance capacity of a muscle. A DTI-based method has been recently considered as a new reference standard to validate measurement of muscle structure in vivo. This study sought to quantify muscle architecture parameters such as fascicle length (FL), pennation angle (PA) and muscle thickness (tm) in post-stroke patients using diffusion tensor imaging (DTI) and to quantitatively compare the differences with 2D ultrasonography (US) and DTI. Muscle fascicles were reconstructed to examine the anatomy of the medial gastrocnemius, posterior soleus and tibialis anterior in seven stroke survivors using US- and DTI-based techniques, respectively. By aligning the US and DTI coordinate system, DTI reconstructed muscle fascicles at the same scanning plane of the US data can be identified. The architecture parameters estimated based on two imaging modalities were further compared. Significant differences were observed for PA and tm between two methods. Although mean FL was not significantly different, there were considerable intra-individual differences in FL and PA. On the individual level, parameters measured by US agreed poorly with those from DTI in both deep and superficial muscles. The significant differences in muscle parameters we observed suggested that the DTI-based method seems to be a better method to quantify muscle architecture parameters which can provide important information for treatment planning and to personalize a computational muscle model.

Normative NeuroFlexor data for detection of spasticity after stroke: a cross-sectional study.

BACKGROUND AND OBJECTIVE: The NeuroFlexor is a novel instrument for quantification of neural, viscous and elastic components of passive movement resistance. The aim of this study was to provide normative data and cut-off values from healthy subjects and to use these to explore signs of spasticity at the wrist and fingers in patients recovering from stroke. METHODS: 107 healthy subjects (age range 28-68 years; 51 % females) and 39 stroke patients (age range 33-69 years; 33 % females), 2-4 weeks after stroke, were assessed with the NeuroFlexor. Cut-off values based on mean + 3SD of the reference data were calculated. In patients, the modified Ashworth scale (MAS) was also applied. RESULTS: In healthy subjects, neural component was 0.8 ± 0.9 N (mean ± SD), elastic component was 2.7 ± 1.1 N, viscous component was 0.3 ± 0.3 N and resting tension was 5.9 ± 1 N. Age only correlated with elastic component (r = -0.3, p = 0.01). Elasticity and resting tension were higher in males compared to females (p = 0.001) and both correlated positively with height (p = 0.01). Values above healthy population cut-off were observed in 16 patients (41 %) for neural component, in 2 (5 %) for elastic component and in 23 (59 %) for viscous component. Neural component above cut-off did not correspond well to MAS ratings. Ten patients with MAS = 0 had neural component values above cut-off and five patients with MAS ≥ 1 had neural component within normal range. CONCLUSION: This study provides NeuroFlexor cut-off values that are useful for detection of spasticity in the early phase after stroke.