Extended Poststroke Rehabilitation Combined with Cerebrolysin Promotes Upper Limb Motor Recovery in Early Subacute Phase of Rehabilitation: A Randomized Clinical Study.

Background and Objectives: The recovery of stroke patients with severe impairment is usually poor and limited and, unfortunately, under-investigated in clinical studies. In order to support neuroplasticity and modulate motor recovery, Cerebrolysin combined with rehabilitation treatment has proven effective in the acute stroke phase in moderate to severe motor impairment. The aim of this study was to determine the efficacy of extended poststroke rehabilitation combined with Cerebrolysin on upper limb motor recovery in subacute stroke patients with severe upper limb motor impairment. Materials and Methods: A randomized, double-blind, placebo-controlled study was conducted. Sixty patients at the early stage of severe sub-acute stroke who fulfilled all eligibility criteria were randomly assigned to the Cerebrolysin group or placebo group (𝑛 = 30 each). Both groups, after conducting three weeks of conventional rehabilitation treatment five days per week, continued to perform conventional rehabilitation treatment three times per week until 90 days of rehabilitation treatment. The primary outcome measure was the Action Research Arm Test (ARAT), and the secondary outcomes were the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score, Barthel index (BI), and the National Institutes of Health Stroke Scale (NIHSS). The outcome data were evaluated before, after three weeks of treatment, and on the 90th day of rehabilitation treatment, and compared within groups and between the two groups. There were no adverse events. Results: Both groups showed a significant improvement (p < 0.001) over time in BI, FMA-UE, ARAT, and NIHSS scores. Patients receiving Cerebrolysin showed more significant improvement in post-stroke upper limb motor impairment and functioning compared to the placebo group after only three weeks, and the trend was maintained after 90 days of follow up. Conclusion: Cerebrolysin delivered in the early subacute post-stroke phase added to extended conventional rehabilitation treatment is beneficial and improves motor functional recovery in patients with severe motor impairment, especially on the paretic upper extremity.

Validation of the Neck Disability Index in Serbian Patients With Cervical Radiculopathy.

OBJECTIVE: The purpose of this study was to translate the Neck Disability Index into the Serbian language (NDI-S) and to investigate the validity of this version for use in Serbian population. METHODS: Fifty patients with cervical radiculopathy were enrolled in the study and completed a multidimensional questionnaire, including NDI-S. Inclusion criteria were ages between 18 and 65 years, Serbian speaking, no cognitive or hearing impairment, sharp and radiating neck and upper extremity pain that has lasted less than 12 months, radiculopathy signs evaluated by electromyoneurography and disc herniation, or spondylotic changes of cervical spine visualized on magnetic resonance imaging. Exclusion criteria were malignancy, previous cervical spine discectomy, trauma of the cervical spine and myelopathy, polyneuropathy, fibromyalgia, and psychiatric disorders. Validity was determined by the correlation of the Neck Disability Index, with pain measured by visual analogue scale, characteristics related to pain, and mental status. Also, factor structure of NDI-S was explored through factor analysis. Reliability was assessed through internal consistency (Cronbach's α and item-total correlations). RESULTS: Correlation analysis between pain and NDI-S showed significant values (P < .01). The NDI-S correlated well with patients mental status (r = 0.421, P < .01). Cronbach's α of NDI-S was 0.85, denoting excellent internal consistency of the questionnaire. Item-total correlations were significant and ranged from 0.328 to 0.789. Factor analysis demonstrated a 2-factor structure with an explained variance of 55%. CONCLUSION: The NDI-S is a valid questionnaire to measure neck and arm pain related to disability in Serbian patients with cervical radiculopathy.

Transcranial application of near-infrared low-level laser can modulate cortical excitability.

BACKGROUND AND OBJECTIVE: Near-infrared low-level laser (NIR-LLL) irradiation penetrates scalp and skull and can reach superficial layers of the cerebral cortex. It was shown to improve the outcome of acute stroke in both animal and human studies. In this study we evaluated whether transcranial laser stimulation (TLS) with NIR-LLL can modulate the excitability of the motor cortex (M1) as measured by transcranial magnetic stimulation (TMS). METHODS: TLS was applied for 5 minutes over the representation of the right first dorsal interosseal muscle (FDI) in left primary motor cortex (M1), in 14 healthy subjects. Motor evoked potentials (MEPs) from the FDI, elicited by single-pulse TMS, were measured at baseline and up to 30 minutes after the TLS. RESULTS: The average MEP size was significantly reduced during the first 20 minutes following the TLS. The pattern was present in 10 (71.5%) of the participants. The MEP size reduction correlated negatively with the motor threshold at rest. CONCLUSIONS: TLS with NIR-LLL induced transitory reduction of the excitability of the stimulated cortex. These findings give further insights into the mechanisms of TLS effects in the human cerebral cortex, paving the way for potential applications of TLS in treatment of stroke and in other clinical settings.

Low-level laser therapy for acute neck pain with radiculopathy: a double-blind placebo-controlled randomized study.

OBJECTIVE: The objective of the study was to investigate clinical effects of low-level laser therapy (LLLT) in patients with acute neck pain with radiculopathy. DESIGN: Double-blind, randomized, placebo-controlled study. SETTING: The study was carried out between January 2005 and September 2007 at the Clinic for Rehabilitation at the Medical School, University of Belgrade, Serbia. PATIENTS AND INTERVENTION: Sixty subjects received a course of 15 treatments over 3 weeks with active or an inactivated laser as a placebo procedure. LLLT was applied to the skin projection at the anatomical site of the spinal segment involved with the following parameters: wavelength 905 nm, frequency 5,000 Hz, power density of 12 mW/cm(2), and dose of 2 J/cm(2), treatment time 120 seconds, at whole doses 12 J/cm(2). OUTCOME MEASURES: The primary outcome measure was pain intensity as measured by a visual analog scale. Secondary outcome measures were neck movement, neck disability index, and quality of life. Measurements were taken before treatment and at the end of the 3-week treatment period. RESULTS: Statistically significant differences between groups were found for intensity of arm pain (P = 0.003, with high effect size d = 0.92) and for neck extension (P = 0.003 with high effect size d = 0.94). CONCLUSION: LLLT gave more effective short-term relief of arm pain and increased range of neck extension in patients with acute neck pain with radiculopathy in comparison to the placebo procedure.

Difference between subjects in early chronic phase of low back pain with and without neuropathic component: observational cross-sectional study.

BACKGROUND: Neuropathic pain in early chronic low back pain is insufficiently recognized and treated. AIM: The aim of this study was to establish if there is a difference among chronic low back pain subjects with and without neuropathic pain and healthy subjects, in clinical characteristic and the level of trunk muscle activation. DESIGN: Cross sectional observational study. SETTING: Rehabilitation clinic, inpatient and outpatient. POPULATION: Thirty-three subjects in early chronic phase of low back pain and 26 healthy subjects were included in this research. METHODS: Clinical characteristics and relative thickness change of lumbar multifidus and transversal abdominal muscle, measured by ultrasound, in neuropathic, non-neuropathic chronic low back pain and healthy subjects were analyzed. RESULTS: Chronic low back pain subjects with neuropathic pain reported higher level of pain on Visual Analog Scale (VAS) (back pain P=0.016, leg pain P=0.006), had higher Oswestry Disability Score (P=0.029), had lower motor (P=0.001) and sensory leg scores (P=0.000), and decreased level of activation of transversal abdominal muscle (P=0.000) comparing to chronic low back pain group without neuropathic pain. Low back pain subjects with leg pain ≥5 on VAS were 11.2 times more prone to develop neuropathic pain. Motor leg score ≤47 increases this chance 35 times. Sensory leg score ≤25 increases this chance 14 times. Reduced activation of transversal abdominal muscle for 40-50% increases this chance 7-24 times. CONCLUSIONS: Chronic low back pain subjects with neuropathic pain were more painful and disabled, had lower motor and sensory scores, and lower relative thickness change of transversal abdominal muscle comparing to the low back pain group without neuropathic pain. Self -reported leg pain intensity of 5 or more on VAS, motor score of 47 and less, sensory scores of 25 and less and diminished activation of transversal abdominal muscle significantly increase the chance that chronic low back pain subject has neuropathic component of pain. CLINICAL REHABILITATION IMPACT: Neuropathic pain in early chronic low back pain subjects might be more readily recognized if patients with radiculopathy and diminished activation of transversal abdominal muscle were regularly screened for neuropathic pain.

Validation of computerized square-drawing based evaluation of motor function in patients with stroke.

Human-administered clinical scales are commonly used for quantifying motor performance and determining the course of therapy in post-stroke individuals. Computerized methods aim to improve consistency, resolution and duration of patients' evaluation. The objective of this study was to test the validity of computerized square-drawing test (DT) for assessment of shoulder and elbow function by using novel set of DT-based kinematic measures and explore their relation with Wolf Motor Function Test (WMFT) scoring. Forty-seven stroke survivors were tested before and after the rehabilitation program. DT involved drawing a square in horizontal plane using a mechanical manipulandum and a digitizing board. Depending on the initial classification of patients into low or high performance groups, the two different outcome metrics were derived from DT kinematic data for evaluation of each group. Linear regression models applied to map DT outcome values to WMFT scores for both groups resulted with high correlation coefficients and low mean absolute prediction error. In conclusion, we have identified a set of kinematic measures suitable for fast and objective motor function evaluation and functional classification, strongly correlating with WMFT score in post-stroke individuals. The results support validation of square-drawing motor function assessment, encouraging its use in clinical settings.

ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial.

The ArmAssist is a simple low-cost robotic system for upper limb motor training that combines known benefits of repetitive task-oriented training, greater intensity of practice, and less dependence on therapist assistance. The aim of this preliminary study was to compare the efficacy of ArmAssist (AA) robotic training against matched conventional arm training in subacute stroke subjects with moderate-to-severe upper limb impairment. Twenty-six subjects were enrolled within 3 months of stroke and randomly assigned to the AA group or Control group (n = 13 each). Both groups were trained 5 days per week for 3 weeks. The primary outcome measure was Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score, and the secondary outcomes were Wolf Motor Function Test-Functional Ability Scale (WMFT-FAS) and Barthel index (BI). The AA group, in comparison to the Control group, showed significantly greater increases in FMA-UE score (18.0 ± 9.4 versus 7.5 ± 5.5, p = 0.002) and WMFT-FAS score (14.1 ± 7.9 versus 6.7 ± 7.8, p = 0.025) after 3 weeks of treatment, whereas the increase in BI was not significant (21.2 ± 24.8 versus 13.1 ± 10.7, p = 0.292). There were no adverse events. We conclude that arm training using the AA robotic device is safe and able to reduce motor deficits more effectively than matched conventional arm training in subacute phase of stroke. The study has been registered at the ClinicalTrials.gov, ID: NCT02729649.

Validation of the Serbian Version of Multiple Sclerosis Spasticity Scale 88 (MSSS-88).

OBJECTIVE: Multiple Sclerosis Spasticity Scale (MSSS)-88 has been developed for self-assessment of spasticity symptoms in patients with multiple sclerosis (MS). The objective of this study was to validate MSSS-88 and evaluate the psychometric properties in patients with MS in Serbia. METHODS: The study comprised 65 MS patients with spasticity. MSSS-88 consists of 88 items grouped in eight sections. Internal consistency of the MSSS-88SR subscales was determined using Cronbach's alpha coefficient. Test/retest reliability with an intra-class correlation coefficient (ICC) for each MSSS-88SR subscale was performed. Clinical validity of MSSS-88SR was determined by correlations with the Numeric Rating Scale (NRS) and the Modified Ashworth Scale (MAS). RESULTS: The range of Cronbach's alpha for all scales and ICC was 0.91-0.96 and 0.84-0.91, respectively. All ICCs were statistically significant (p<0.05). All evaluated subscales of MSSS-88 were significantly correlated with the NRS scale. The highest correlation coefficients were registered between the WL subscale and the EDSS and MAS, while the strongest relationship was observed between the MSS subscale and the NRS. CONCLUSION: The Serbian translated version of this instrument may be useful as a clinical measure for spasticity and functionality in patients with MS.

Gait training of poststroke patients assisted by the Walkaround (body postural support).

Improvement in gait abilities is one of the important goals of stroke rehabilitation. The Walkaround is a new postural assistance device for gait training, which allows an early start for gait training. This device provides body postural support (BPS) and trunk orientation by means of a lumbar belt that is connected to a powered rolling walker. We conducted a randomized, single-blinded, 4-week clinical trial of 22 subacute stroke patients with a follow-up period of 6 months. Patients were divided into two identically sized groups: the treatment group (BPS), which was assisted by the Walkaround, and the control (CON) group, which was assisted by conventional means (cane, therapist) during gait training. The objective of the study was to assess whether the Walkaround is more effective than conventional assistance during gait training. The outcome measures were as follows: Barthel index, Fugl-Meyer score for the lower extremities, Berg balance test, and gait speed. Changes in the outcome measures were significant for the Berg balance score after 6 months in both groups and in gait speed among the BPS group at the end of therapy and after 6 months (P<0.05) compared with the same outcome measures at the beginning of the trial. Significant differences were found in gait speed and Berg balance test scores after 4 weeks and in gait speed after 6 months (P<0.05) between the BPS and the CON groups. The results suggest that added postural support by the Walkaround led to limited yet significant changes in gait speed and balance control.

Feedback-mediated upper extremities exercise: increasing patient motivation in poststroke rehabilitation.

PURPOSE: This proof-of-concept study investigated whether feedback-mediated exercise (FME) of the affected arm of hemiplegic patients increases patient motivation and promotes greater improvement of motor function, compared to no-feedback exercise (NFE). METHOD: We developed a feedback-mediated treatment that uses gaming scenarios and allows online and offline monitoring of both temporal and spatial characteristics of planar movements. Twenty poststroke hemiplegic inpatients, randomly assigned to the FME and NFE group, received therapy five days a week for three weeks. The outcome measures were evaluated from the following: (1) the modified drawing test (mDT), (2) received therapy time-RTT, and (3) intrinsic motivation inventory-IMI. RESULTS: The FME group patients showed significantly higher improvement in the speed metric (P < 0.01), and smoothness metric (P < 0.01), as well as higher RTT (P < 0.01). Significantly higher patient motivation is observed in the FME group (interest/enjoyment subscale (P < 0.01) and perceived competence subscale (P < 0.01)). CONCLUSION: Prolonged endurance in training and greater improvement in certain areas of motor function, as well as very high patient motivation and strong positive impressions about the treatment, suggest the positive effects of feedback-mediated treatment and its high level of acceptance by patients.

Acute low back pain with radiculopathy: a double-blind, randomized, placebo-controlled study.

OBJECTIVE: The aim of this study was to investigate the clinical effects of low-level laser therapy (LLLT) in patients with acute low back pain (LBP) with radiculopathy. BACKGROUND DATA: Acute LBP with radiculopathy is associated with pain and disability and the important pathogenic role of inflammation. LLLT has shown significant anti-inflammatory effects in many studies. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was performed on 546 patients. Group A (182 patients) was treated with nimesulide 200 mg/day and additionally with active LLLT; group B (182 patients) was treated only with nimesulide; and group C (182 patients) was treated with nimesulide and placebo LLLT. LLLT was applied behind the involved spine segment using a stationary skin-contact method. Patients were treated 5 times weekly, for a total of 15 treatments, with the following parameters: wavelength 904 nm; frequency 5000 Hz; 100-mW average diode power; power density of 20 mW/cm(2) and dose of 3 J/cm(2); treatment time 150 sec at whole doses of 12 J/cm(2). The outcomes were pain intensity measured with a visual analog scale (VAS); lumbar movement, with a modified Schober test; pain disability, with Oswestry disability score; and quality of life, with a 12-item short-form health survey questionnaire (SF-12). Subjects were evaluated before and after treatment. Statistical analyses were done with SPSS 11.5. RESULTS: Statistically significant differences were found in all outcomes measured (p < 0.001), but were larger in group A than in B (p < 0.0005) and C (p < 0.0005). The results in group C were better than in group B (p < 0.0005). CONCLUSIONS: The results of this study show better improvement in acute LBP treated with LLLT used as additional therapy.