Comparing the effects of augmented virtual reality treadmill training versus conventional treadmill training in patients with stage II-III Parkinson's disease: the VIRTREAD-PD randomized controlled trial protocol.

Background: Intensive treadmill training (TT) has been documented to improve gait parameters and functional independence in Parkinson's Disease (PD), but the optimal intervention protocol and the criteria for tailoring the intervention to patients' performances are lacking. TT may be integrated with augmented virtual reality (AVR), however, evidence of the effectiveness of this combined treatment is still limited. Moreover, prognostic biomarkers of rehabilitation, potentially useful to customize the treatment, are currently missing. The primary aim of this study is to compare the effects on gait performances of TT + AVR versus TT alone in II-III stage PD patients with gait disturbance. Secondary aims are to assess the effects on balance, gait parameters and other motor and non-motor symptoms, and patient's satisfaction and adherence to the treatment. As an exploratory aim, the study attempts to identify biomarkers of neuroplasticity detecting changes in Neurofilament Light Chain concentration T0-T1 and to identify prognostic biomarkers associated to blood-derived Extracellular Vesicles. Methods: Single-center, randomized controlled single-blind trial comparing TT + AVR vs. TT in II-III stage PD patients with gait disturbances. Assessment will be performed at baseline (T0), end of training (T1), 3 (T2) and 6 months (T3, phone interview) from T1. The primary outcome is difference in gait performance assessed with the Tinetti Performance-Oriented Mobility Assessment gait scale at T1. Secondary outcomes are differences in gait performance at T2, in balance and spatial-temporal gait parameters at T1 and T2, patients' satisfaction and adherence. Changes in falls, functional mobility, functional autonomy, cognition, mood, and quality of life will be also assessed at different timepoints. The G*Power software was used to estimate a sample size of 20 subjects per group (power 0.95, α < 0.05), raised to 24 per group to compensate for potential drop-outs. Both interventions will be customized and progressive, based on the participant's performance, according to a predefined protocol. Conclusion: This study will provide data on the possible superiority of AVR-associated TT over conventional TT in improving gait and other motor and non-motor symptoms in persons with PD and gait disturbances. Results of the exploratory analysis could add information in the field of biomarker research in PD rehabilitation.

The muscle shortening maneuver in individuals with stroke: a consideration-of-concept randomized pilot trial.

BACKGROUND AND PURPOSE: The Muscle Shortening Maneuver (MSM) is derived from Feldman's λ model of motor control, and seems to induce a more balanced agonist- antagonist-muscular action. The hypothesized mechanism of action is a modulation of the Tonic Stretch Reflex Threshold (TSRT). We designed a pilot, randomized trial aimed to explore the mechanisms of action of the technique. An ancillary objective was to research the implementation of the MSM as a stroke rehabilitation intervention. METHODS: A sample of 10 participants with chronic stroke was enrolled and randomly assigned to MSM (n, 5) or conventional physical therapy (CPT) (n, 5) treatments. The TSRTs were assessed by the Montreal Spasticity Measure device. A selection of clinical and instrumental outcome measures was taken to investigate function and activity levels. Data were collected at baseline, end-of-treatment, and one month after the end-of-treatment. RESULTS: No adverse events were observed. In both between- and within-group post-treatment assessments, in the affected ankle the MSM group showed decreased TSRTs of the plantar flexor, increased strength of the dorsiflexor and active range of motion; also, the time needed to perform the Timed Up and Go test decreased. No changes were evident across assessments in the CPT group. DISCUSSION AND CONCLUSIONS: The MSM seems able to modulate the TSRTs in individuals with stroke. Although with the limitations due to the pilot design, the variation in participants' responses appear to be promising. Many methodological issues have to be clarified and specified conceiving the progression toward a confirmatory trial.

Effects of laser therapy and Grimaldi's muscle shortening manoeuvre on motor control of subjects with incomplete spinal cord injuries.

BACKGROUND AND OBJECTIVES: From year 2003 we treated positively 251 patients with Traumatic Spinal Cord Injuries (TSCI), using Non-Surgical Laser Therapy (NSLT). In order to increase muscle strength, we have also started using a physical therapy practice called Grimaldi's Muscle Shortening Manoeuvre (GMSM)The goal of our study is to obtain objective data suggesting the real effectiveness of the association of these two treatments. STUDY DESIGN AND METHODS: In 2015, 10 patients with incomplete TSCI were enrolled. Further 10 subjects with similar features were included as control group. All patients have subtotal sensory loss and motor paralysis below the level of the lesion. Lasers used were 808, 10600, and 1064 nm, applied with a first cycle of four sessions per day for a total of 20 sessions. The patients participated in specific physical therapy training (GMSM) twice a day, for a total of eight sessions.Each cycle of laser and GMSM was replicated each month. RESULTS: Results were considered positive if sensitivity increased at least two dermatomes per cycle under the level of the lesion. Results in muscle activity (on/off) were regarded as positive if sEMG showed modifications in CNS-muscle. Objective assessment of force displayed encouraging results. After each cycle, patients showed improvements in motor function and voluntary command. Follow-up is positive after 3 months. CONCLUSION: Associating laser treatment and Grimaldi's Muscle Shortening Manoeuvre (MSM) seems to be effective on muscle strength and motor control in patients affected by subtotal SCI compared to a control group.