Dataset Information

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol.

ABSTRACT: Background: The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. Methods: To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment. The primary outcome measures will be a set of standard clinical scales for upper limb spasticity and motor function assessment, including the Modified Ashworth Scale and Fugl-Meyer Index, to confirm the safety and evaluate the efficacy of robotic rehabilitation in reducing elbow stiffness and improving function. Secondary outcomes will include biomechanical, muscular activity, and motor performance parameters extracted from instrumented assessments using the NEEM along with synchronous EMG recordings. Conclusions: This randomized controlled trial aims to validate an innovative instrumented methodology for clinical spasticity assessment and functional rehabilitation, relying on the precision and accuracy of an elbow exoskeleton combined with EMG recordings and the expertise of a physiotherapist, thus complementing and maximizing the benefits of both practices. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04484571.

SUBMITTER: Pilla A

PROVIDER: S-EPMC7643017 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol.

Pilla Alessandro A Trigili Emilio E McKinney Zach Z Fanciullacci Chiara C Malasoma Chiara C Posteraro Federico F Crea Simona S Vitiello Nicola N

Frontiers in neurology 20201022

<b>Background:</b> The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluatio ...[more]

PMID: 33193052

Similar Datasets

Project description:Brain-computer interfaces (BCIs) can provide sensory feedback of ongoing brain oscillations, enabling stroke survivors to modulate their sensorimotor rhythms purposefully. A number of recent clinical studies indicate that repeated use of such BCIs might trigger neurological recovery and hence improvement in motor function. Here, we provide a first meta-analysis evaluating the clinical effectiveness of BCI-based post-stroke motor rehabilitation. Trials were identified using MEDLINE, CENTRAL, PEDro and by inspection of references in several review articles. We selected randomized controlled trials that used BCIs for post-stroke motor rehabilitation and provided motor impairment scores before and after the intervention. A random-effects inverse variance method was used to calculate the summary effect size. We initially identified 524 articles and, after removing duplicates, we screened titles and abstracts of 473 articles. We found 26 articles corresponding to BCI clinical trials, of these, there were nine studies that involved a total of 235 post-stroke survivors that fulfilled the inclusion criterion (randomized controlled trials that examined motor performance as an outcome measure) for the meta-analysis. Motor improvements, mostly quantified by the upper limb Fugl-Meyer Assessment (FMA-UE), exceeded the minimal clinically important difference (MCID=5.25) in six BCI studies, while such improvement was reached only in three control groups. Overall, the BCI training was associated with a standardized mean difference of 0.79 (95% CI: 0.37 to 1.20) in FMA-UE compared to control conditions, which is in the range of medium to large summary effect size. In addition, several studies indicated BCI-induced functional and structural neuroplasticity at a subclinical level. This suggests that BCI technology could be an effective intervention for post-stroke upper limb rehabilitation. However, more studies with larger sample size are required to increase the reliability of these results.

Project description:Background: After a stroke, up to three-quarters of acute and subacute stroke survivors exhibit cognitive impairment, with a significant impact on functional recovery, quality of life, and social engagement. Robotic therapy has shown its effectiveness on motor recovery, but its effectiveness on cognitive recovery has not fully investigated. Objective: This study aims to assess the impact of a technological rehabilitation intervention on cognitive functions in patients with stroke, using a set of three robots and one sensor-based device for upper limb rehabilitation. Methods: This is a pilot study in which 51 patients were enrolled. An upper limb rehabilitation program was performed using three robots and one sensor-based device. The intervention comprised motor/cognitive exercises, especially selected among the available ones to train also cognitive functions. Patients underwent 30 rehabilitation sessions, each session lasting 45 minutes, 5 days a week. Patients were assessed before and after the treatment with several cognitive tests (Oxford Cognitive Scale, Symbol Digit Modalities Test, Digit Span, Rey-Osterrieth Complex Figure, Tower of London, and Stroop test). In addition, motor (Fugl-Meyer Assessment and Motricity Index) and disability (modified Barthel Index) scales were used. Results: According to the Oxford Cognitive Scale domains, a significant percentage of patients exhibited cognitive deficits. Excluding perception (with only one patient impaired), the domain with the lowest percentage of patients showing a pathological score was praxis (about 25%), while the highest percentage of impaired patients was found in calculation (about 70%). After the treatment, patients improved in all the investigated cognitive domains, as measured by the selected cognitive assessment scales. Moreover, motor and disability scales confirmed the efficacy of robotics on upper limb rehabilitation in patients with stroke. Conclusions: This explorative study suggests that robotic technology can be used to combine motor and cognitive exercises in a unique treatment session. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04164381.

Project description:BackgroundA novel electromechanical robotic-exoskeleton was designed in-house for the rehabilitation of wrist joint and Metacarpophalangeal (MCP) joint.ObjectiveThe objective was to compare the rehabilitation effectiveness (clinical-scales and neurophysiological-measures) of robotic-therapy training sessions with dose-matched conventional therapy in patients with stroke.MethodsA pilot prospective parallel randomized controlled study at clinical settings was designed for patients with stroke within 2 years of chronicity. Patients were randomly assigned to receive an intervention of 20 sessions of 45 min each, five days a week for four weeks, in Robotic-therapy Group (RG) (n = 12) and conventional upper-limb rehabilitation in Control-Group (CG) (n = 11). We intended to evaluate the effects of a novel exoskeleton based therapy on the functional rehabilitation outcomes of upper-limb and cortical-excitability in patients with stroke as compared to the conventional-rehabilitation. Clinical-scales- Modified Ashworth Scale, Active Range of Motion, Barthel-Index, Brunnstrom-stage and Fugl-Meyer (FM) scale and neurophysiological measures of cortical-excitability (using Transcranial Magnetic Stimulation) -Motor Evoked Potential and Resting Motor threshold, were acquired pre- and post-therapy.ResultsNo side effects were noticed in any of the patients. Both RG and CG showed significant (p < 0.05) improvement in all clinical motor-outcomes except Modified Ashworth Scale in CG. RG showed significantly (p < 0.05) higher improvement over CG in Modified Ashworth Scale, Active Range of Motion and Fugl-Meyer scale and FM Wrist-/Hand component. An increase in cortical-excitability in ipsilesional-hemisphere was found to be statistically significant (p < 0.05) in RG over CG, as indexed by a decrease in Resting Motor Threshold and increase in the amplitude of Motor Evoked Potential. No significant changes were shown by the contralesional-hemisphere. Interhemispheric RMT-asymmetry evidenced significant (p < 0.05) changes in RG over CG indicating increased cortical-excitability in ipsilesional-hemisphere along with interhemispheric changes.ConclusionRobotic-exoskeleton training showed improvement in motor outcomes and cortical-excitability in patients with stroke. Neurophysiological changes in RG could most likely be a consequence of plastic reorganization and use-dependent plasticity. Trial registry number: ISRCTN95291802.

Project description:Loss of motor function is a common deficit following stroke insult and often manifests as persistent upper extremity (UE) disability which can affect a survivor's ability to participate in activities of daily living. Recent research suggests the use of brain-computer interface (BCI) devices might improve UE function in stroke survivors at various times since stroke. This randomized crossover-controlled trial examines whether intervention with this BCI device design attenuates the effects of hemiparesis, encourages reorganization of motor related brain signals (EEG measured sensorimotor rhythm desynchronization), and improves movement, as measured by the Action Research Arm Test (ARAT). A sample of 21 stroke survivors, presenting with varied times since stroke and levels of UE impairment, received a maximum of 18-30 h of intervention with a novel electroencephalogram-based BCI-driven functional electrical stimulator (EEG-BCI-FES) device. Driven by spectral power recordings from contralateral EEG electrodes during cued attempted grasping of the hand, the user's input to the EEG-BCI-FES device modulates horizontal movement of a virtual cursor and also facilitates concurrent stimulation of the impaired UE. Outcome measures of function and capacity were assessed at baseline, mid-therapy, and at completion of therapy while EEG was recorded only during intervention sessions. A significant increase in r-squared values [reflecting Mu rhythm (8-12 Hz) desynchronization as the result of attempted movements of the impaired hand] presented post-therapy compared to baseline. These findings suggest that intervention corresponds with greater desynchronization of Mu rhythm in the ipsilesional hemisphere during attempted movements of the impaired hand and this change is related to changes in behavior as a result of the intervention. BCI intervention may be an effective way of addressing the recovery of a stroke impaired UE and studying neuromechanical coupling with motor outputs. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02098265.

Project description:Stroke is the primary cause of adult disability. To support this large population in recovery, robotic technologies are being developed to assist in the delivery of rehabilitation. This paper presents an automated system for a rehabilitation robotic device that guides stroke patients through an upper-limb reaching task. The system uses a decision theoretic model (a partially observable Markov decision process, or POMDP) as its primary engine for decision making. The POMDP allows the system to automatically modify exercise parameters to account for the specific needs and abilities of different individuals, and to use these parameters to take appropriate decisions about stroke rehabilitation exercises.The performance of the system was evaluated by comparing the decisions made by the system with those of a human therapist. A single patient participant was paired up with a therapist participant for the duration of the study, for a total of six sessions. Each session was an hour long and occurred three times a week for two weeks. During each session, three steps were followed: (A) after the system made a decision, the therapist either agreed or disagreed with the decision made; (B) the researcher had the device execute the decision made by the therapist; (C) the patient then performed the reaching exercise. These parts were repeated in the order of A-B-C until the end of the session. Qualitative and quantitative question were asked at the end of each session and at the completion of the study for both participants.Overall, the therapist agreed with the system decisions approximately 65% of the time. In general, the therapist thought the system decisions were believable and could envision this system being used in both a clinical and home setting. The patient was satisfied with the system and would use this system as his/her primary method of rehabilitation.The data collected in this study can only be used to provide insight into the performance of the system since the sample size was limited. The next stage for this project is to test the system with a larger sample size to obtain significant results.

Project description:ObjectiveTo investigate the potential benefits of 3 therapeutic instrumental music performance (TIMP)-based interventions in rehabilitation of the affected upper-extremity (UE) for adults with chronic poststroke hemiparesis.DesignRandomized-controlled pilot study.SettingUniversity research facility.ParticipantsCommunity-dwelling volunteers (N=30; 16 men, 14 women; age range, 33-76 years; mean age, 55.9 years) began and completed the protocol. All participants had sustained a unilateral stroke more than 6 months before enrollment (mean time poststroke, 66.9 months).InterventionTwo baseline assessments, a minimum of 1 week apart; 9 intervention sessions (3 times/week for 3 weeks), in which rhythmically cued, functional arm movements were mapped onto musical instruments; and 1 post-test following the final intervention. Participants were block-randomized to 1 of 3 conditions: group 1 (45 minutes TIMP), group 2 (30 minutes TIMP, 15 minutes metronome-cued motor imagery [TIMP+cMI]), and group 3 (30 minutes TIMP, 15 minutes motor imagery without cues [TIMP+MI]). Assessors and investigators were blinded to group assignment.Main outcome measuresFugl-Meyer Upper-Extremity (FM-UE) and Wolf Motor Function Test- Functional Ability Scale (WMFT-FAS). Secondary measures were motor activity log (MAL)-amount of use scale and trunk impairment scale.ResultsAll groups made statistically significant gains on the FM-UE (TIMP, P=.005, r=.63; TIMP+cMI, P=.007, r=.63; TIMP+MI, P=.007, r=.61) and the WMFT-FAS (TIMP, P=.024, r=.53; TIMP+cMI, P=.008, r=.60; TIMP+MI, P=.008, r=.63). Comparing between-group percent change differences, on the FM-UE, TIMP scored significantly higher than TIMP+cMI (P=.032, r=.57), but not TIMP+MI. There were no differences in improvement on WMFT-FAS across conditions. On the MAL, gains were significant for TIMP (P=.030, r=.54) and TIMP+MI (P=.007, r=.63).ConclusionTIMP-based techniques, with and without MI, led to significant improvements in paretic arm control on primary outcomes. Replacing a physical training segment with imagery-based training resulted in similar improvements; however, synchronizing internal and external cues during auditory-cMI may pose additional sensorimotor integration challenges.

Dataset Information

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol.

Publications

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets