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Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial.

ABSTRACT: BACKGROUND:We evaluated the effectiveness of robot-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT) on stroke patients with hand paralysis. METHODS:A randomized controlled trial was conducted. Thirty-two patients, 34.4% female (mean ± SD age: 68.9 ± 11.6 years), with hand paralysis after stroke participated. The experimental group received 30 minutes of passive mobilization of the hand through the robotic device Gloreha (Brescia, Italy)?, and the control group received an additional 30 minutes of PT and OT for 3 consecutive weeks (3 d/wk) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale, Barthel Index (BI), Motricity Index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and the visual analog scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks). RESULTS:A significant effect of time interaction existed for NIHSS, BI, MI, and QuickDASH, after stroke immediately after the interventions (all, P < .001). The experimental group had a greater reduction in pain compared with the control group at the end of the intervention, a reduction of 11.3 mm compared with 3.7 mm, using the 100-mm VAS scale. CONCLUSIONS:In the treatment of pain and spasticity in hand paralysis after stroke, robot-assisted mobilization performed in conjunction with traditional PT and OT is as effective as traditional rehabilitation.

SUBMITTER: Villafane JH

PROVIDER: S-EPMC5755871 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial.

Villafañe Jorge H JH Taveggia Giovanni G Galeri Silvia S Bissolotti Luciano L Mullè Chiara C Imperio Grace G Valdes Kristin K Borboni Alberto A Negrini Stefano S

Hand (New York, N.Y.) 20170216 1

<h4>Background</h4>We evaluated the effectiveness of robot-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT) on stroke patients with hand paralysis.<h4>Methods</h4>A randomized controlled trial was conducted. Thirty-two patients, 34.4% female (mean ± SD age: 68.9 ± 11.6 years), with hand paralysis after stroke participated. The experimental group received 30 minutes of passive mobilization of the hand through the robotic device Gloreha (Brescia, Italy ...[more]

PMID: 28719996

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Project description:BackgroundHand function is often impaired after stroke, strongly affecting the ability to perform daily activities. Upper limb robotic devices have been developed to complement rehabilitation therapy offered to persons who suffered a stroke, but they rarely focus on the training of hand sensorimotor function. The primary goal of this study was to evaluate whether robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks) produces an equivalent decrease in upper limb motor impairment compared to dose-matched conventional neurocognitive therapy, when embedded in the rehabilitation program of inpatients in the subacute stage after stroke.MethodsA parallel-group, randomized controlled trial was conducted on subjects with subacute stroke receiving either conventional or robot-assisted neurocognitive hand therapy using a haptic device. Therapy was provided for 15, 45-min sessions over four weeks, nested within the standard therapy program. Primary outcome was the change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE) after the intervention, which was compared between groups using equivalence testing. Secondary outcome measures included upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance.ResultsThirty-three participants with stroke were enrolled. 14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study. At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.ConclusionsNeurocognitive robot-assisted therapy of hand function allows for a non-inferior motor recovery compared to conventional dose-matched neurocognitive therapy when performed during inpatient rehabilitation in the subacute stage. This allows the early familiarization of subjects with stroke to the use of such technologies, as a first step towards minimal therapist supervision in the clinic, or directly at home after hospital discharge, to help increase the dose of hand therapy for persons with stroke.Trial registrationEUDAMED database (CIV-13-02-009921), clinicaltrials.gov (NCT02096445). Registered 26 March 2014 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02096445.

Project description:Purpose: Robot-assisted training has been widely used in neurorehabilitation, but its effect on facilitating recovery after stroke remains controversial. One possible reason might be lacking consideration of the role of embodiment in robotic systems. Mirror visual feedback is an ideal method to approach embodiment. Thus, we hypothesized that mirror visual feedback priming with subsequent robot-assisted training might provide additional treatment benefits in rehabilitation. Method: This is a prospective, assessor-blinded, randomized, controlled study. Forty subacute stroke patients were randomly assigned into an experimental group (N = 20) or a control group (N = 20). They received either mirror visual feedback or sham-mirror visual feedback prior to robot-assisted training for 1.5 h/day, 5 days/week for 4 weeks. Before and after intervention, the Fugl-Meyer Assessment Upper Limb subscale, the Functional Independence Measure, the modified Barthel Index, and grip strength were measured. Scores of four specified games were recorded pre and post one-time mirror visual feedback priming before intervention in the experimental group. Results: All measurements improved significantly in both groups following interventions. Moreover, the Fugl-Meyer Assessment Upper Limb subscale, self-care subscale of the Functional Independence Measure, and the grip strength were improved significantly in the experimental group after a 4-week intervention, compared with the control group. Significantly higher scores of two games were revealed after one-time priming. Conclusions: Mirror visual feedback prior to robot-assisted training could prompt motor recovery, increase ability of self-care, and potentially enhance grip strength in stroke patients, compared to control treatment. Moreover, mirror visual feedback priming might have the capability to improve the patient's performance and engagement during robot-assisted training, which could prompt the design and development of robotic systems. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: ChiCTR1900023356.

Project description:BackgroundSelecting and maintaining an engaging and challenging training difficulty level in robot-assisted stroke rehabilitation remains an open challenge. Despite the ability of robotic systems to provide objective and accurate measures of function and performance, the selection and adaptation of exercise difficulty levels is typically left to the experience of the supervising therapist.MethodsWe introduce a patient-tailored and adaptive robot-assisted therapy concept to optimally challenge patients from the very first session and throughout therapy progress. The concept is evaluated within a four-week pilot study in six subacute stroke patients performing robot-assisted rehabilitation of hand function. Robotic assessments of both motor and sensory impairments of hand function conducted prior to the therapy are used to adjust exercise parameters and customize difficulty levels. During therapy progression, an automated routine adapts difficulty levels from session to session to maintain patients' performance around a target level of 70%, to optimally balance motivation and challenge.ResultsRobotic assessments suggested large differences in patients' sensorimotor abilities that are not captured by clinical assessments. Exercise customization based on these assessments resulted in an average initial exercise performance around 70% (62% ± 20%, mean ± std), which was maintained throughout the course of the therapy (64% ± 21%). Patients showed reduction in both motor and sensory impairments compared to baseline as measured by clinical and robotic assessments. The progress in difficulty levels correlated with improvements in a clinical impairment scale (Fugl-Meyer Assessment) (r s = 0.70), suggesting that the proposed therapy was effective at reducing sensorimotor impairment.ConclusionsInitial robotic assessments combined with progressive difficulty adaptation have the potential to automatically tailor robot-assisted rehabilitation to the individual patient. This results in optimal challenge and engagement of the patient, may facilitate sensorimotor recovery after neurological injury, and has implications for unsupervised robot-assisted therapy in the clinic and home environment.Trial registrationClinicalTrials.gov, NCT02096445.

Project description:BackgroundEffective rehabilitative therapies are needed for patients with long-term deficits after stroke.MethodsIn this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.ResultsAt 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.ConclusionsIn patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)

Project description:BackgroundUnsupervised robot-assisted rehabilitation is a promising approach to increase the dose of therapy after stroke, which may help promote sensorimotor recovery without requiring significant additional resources and manpower. However, the unsupervised use of robotic technologies is not yet a standard, as rehabilitation robots often show low usability or are considered unsafe to be used by patients independently. In this paper we explore the feasibility of unsupervised therapy with an upper limb rehabilitation robot in a clinical setting, evaluate the effect on the overall therapy dose, and assess user experience during unsupervised use of the robot and its usability.MethodsSubacute stroke patients underwent a four-week protocol composed of daily 45 min-sessions of robot-assisted therapy. The first week consisted of supervised therapy, where a therapist explained how to interact with the device. The second week was minimally supervised, i.e., the therapist was present but intervened only if needed. After this phase, if participants learnt how to use the device, they proceeded to two weeks of fully unsupervised training. Feasibility, dose of robot-assisted therapy achieved during unsupervised use, user experience, and usability of the device were evaluated. Questionnaires to evaluate usability and user experience were performed after the minimally supervised week and at the end of the study, to evaluate the impact of therapists' absence.ResultsUnsupervised robot-assisted therapy was found to be feasible, as 12 out of the 13 recruited participants could progress to unsupervised training. During the two weeks of unsupervised therapy participants on average performed an additional 360 min of robot-assisted rehabilitation. Participants were satisfied with the device usability (mean System Usability Scale scores > 79), and no adverse events or device deficiencies occurred.ConclusionsWe demonstrated that unsupervised robot-assisted therapy in a clinical setting with an actuated device for the upper limb was feasible and can lead to a meaningful increase in therapy dose. These results support the application of unsupervised robot-assisted therapy as a complement to usual care in clinical settings and pave the way to its application in home settings.Trial registrationRegistered on 13.05.2020 on clinicaltrials.gov (NCT04388891).

Project description:BackgroundWhether extended robot-assisted esophagectomy with thoracic duct resection (RAE-TDR) has a favorable effect on esophageal cancer patients is not yet known. This study sought to analyze the safety and efficiency of RAE-TDR.MethodsFrom January 2019 to July 2020, 73 thoracic duct (TD)-resected and 127 TD-preserved consecutive patients who received standard RAE McKeown surgery were enrolled in this study. The perioperative-related indicators of recurrence-free survival (RFS) and overall survival (OS) at 1-year were compared between the 2 groups.ResultsIn relation to morbidity, the Clavien-Dindo (CD) classifications for grades greater than or equal to II-III were similar between the 2 groups (P>0.05). The number of retrieved total lymph nodes (LNs) and mediastinal nodes were significantly higher in the TD-resected group than in the TD-preserved group (total lymph nodes: 29.0±11.1 vs. 25.1±8.5, P=0.006; mediastinal nodes: 19.5±8.0 vs. 16.1±5.5, P=0.002). Additionally, more metastatic TD-related LNs were harvested in cT3-4 patients (2.3±3.7 vs. 1.7±2.8; P=0.21). The rates of LN recurrence and local recurrence were similar between the 2 groups (LN recurrence: 6.8% vs. 7.1%, P>0.99; local recurrence: 1.4% vs. 2.4%, P>0.99). The OS and RFS at 1-year were equivalent regardless of the TD procedure at each stage (P>0.05). However, the rate of hematogenous metastasis in the TD-resected group was significantly elevated (17.8% vs. 7.9%; P=0.034).ConclusionsRAE-TDR may help to improve total and metastatic LN harvest, especially in patients with advanced esophageal squamous cell carcinoma (ESCC) without increasing the intra- and post-operative adverse events. However, RAE-TDR did not lead to a decrease in the local recurrence rate within the short-term follow-up period. Whether the increase in distant metastasis rate in the TD-resected group was associated with relevant immune system damage is unclear. Thus, nonselective RAE-TDR is not routinely recommended.

Project description:BackgroundIn recent years, many studies focused on the use of robotic devices for both the assessment and the neuro-motor reeducation of upper limb in subjects after stroke, spinal cord injuries or affected by neurological disorders. Contrarily, it is still hard to find examples of robot-aided assessment and rehabilitation after traumatic injuries in the orthopedic field. However, those benefits related to the use of robotic devices are expected also in orthopedic functional reeducation.MethodsAfter a wrist injury occurred at their workplace, wrist functionality of twenty-three subjects was evaluated through a robot-based assessment and clinical measures (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test), before and after a 3-week long rehabilitative treatment. Subjects were randomized in two groups: while the control group (n = 13) underwent a traditional rehabilitative protocol, the experimental group (n = 10) was treated replacing traditional exercises with robot-aided ones.ResultsFunctionality, assessed through the function subscale of PRWE scale, improved in both groups (experimental p = 0.016; control p < 0.001) and was comparable between groups, both pre (U = 45.5, p = 0.355) and post (U = 47, p = 0.597) treatment. Additionally, even though groups' performance during the robotic assessment was comparable before the treatment (U = 36, p = 0.077), after rehabilitation the experimental group presented better results than the control one (U = 26, p = 0.015).ConclusionsThis work can be considered a starting point for introducing the use of robotic devices in the orthopedic field. The robot-aided rehabilitative treatment was effective and comparable to the traditional one. Preserving efficacy and safety conditions, a systematic use of these devices could lead to decrease human therapists' effort, increase repeatability and accuracy of assessments, and promote subject's engagement and voluntary participation. Trial Registration ClinicalTrial.gov ID: NCT04739644. Registered on February 4, 2021-Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT04739644 .

Dataset Information

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial.

Publications

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial.

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