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Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial.

ABSTRACT: Importance:Gait and balance impairment is associated with poorer functional recovery after stroke. The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in patients with stroke, especially for gait and balance functions. Objective:To determine whether cerebellar intermittent ?-burst stimulation (CRB-iTBS) can improve balance and gait functions in patients with hemiparesis due to stroke. Design, Setting, Participants:This randomized, double-blind, sham-controlled phase IIa trial investigated efficacy and safety of a 3-week treatment of CRB-iTBS coupled with physiotherapy in promoting gait and balance recovery in patients with stroke. Thirty-six patients with consecutive ischemic chronic stroke in the territory of the contralateral middle cerebral artery with hemiparesis were recruited from a neuro-rehabilitation hospital. Participants were screened and enrolled from March 2013 to June 2017. Intention-to-treat analysis was performed. Interventions:Patients were randomly assigned to treatment with CRB-iTBS or sham iTBS applied over the cerebellar hemisphere ipsilateral to the affected body side immediately before physiotherapy daily during 3 weeks. Main Outcomes and Measures:The primary outcome was the between-group difference in change from baseline in the Berg Balance Scale. Secondary exploratory measures included the between-group difference in change from baseline in Fugl-Meyer Assessment scale, Barthel Index, and locomotion assessment with gait analysis and cortical activity measured by transcranial magnetic stimulation in combination with electroencephalogram. Results:A total of 34 patients (mean [SD] age, 64?[11.3] years; 13 women [38.2%]) completed the study. Patients treated with CRB-iTBS, but not with sham iTBS, showed an improvement of gait and balance functions, as revealed by a pronounced increase in the mean (SE) Berg Balance Scale score (baseline: 34.5?[3.4]; 3 weeks after treatment: 43.4?[2.6]; 3 weeks after the end of treatment: 47.5?[1.8]; P??.05) and Barthel Index scores (mean [SE], baseline: 71.1 [4.92]; 3 weeks after treatment: 88.8 [2.1]; 3 weeks after the end of treatment: 92.2 [2.4]; P?>?.05). Patients treated with CRB-iTBS, but not sham iTBS, showed a reduction of step width at the gait analysis (mean [SE], baseline: 16.8?[4.8] cm; 3 weeks after treatment: 14.3?[6.2] cm; P?

SUBMITTER: Koch G

PROVIDER: S-EPMC6439971 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial.

Koch Giacomo G Bonnì Sonia S Casula Elias Paolo EP Iosa Marco M Paolucci Stefano S Pellicciari Maria Concetta MC Cinnera Alex Martino AM Ponzo Viviana V Maiella Michele M Picazio Silvia S Sallustio Fabrizio F Caltagirone Carlo C

JAMA neurology 20190201 2

<h4>Importance</h4>Gait and balance impairment is associated with poorer functional recovery after stroke. The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in patients with stroke, especially for gait and balance functions.<h4>Objective</h4>To determine whether cerebellar intermittent θ-burst stimulation (CRB-iTBS) can improve balance and gait functions in patients with hemiparesis due to stroke.<h4>Design, setting, participants</h4>This random ...[more]

PMID: 30476999

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Project description:BackgroundPrevious studies have assessed the effects of perturbation training on balance after stroke. However, the perturbations were either applied while standing or were small in amplitude during gait, which is not representative of the most common fall conditions. The perturbations were also combined with other challenges such as progressive increases in treadmill speed.ObjectiveTo determine the benefit of treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training for dynamic balance and gait post-stroke.MethodsTwenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1 min were allocated to either an unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization. Nine training sessions were conducted over 3 weeks. NonPerturb participants only walked on the treadmill but were offered perturbation training after the control intervention. Pre- and post-training evaluations included balance and gait abilities, maximal knee strength, balance confidence and community integration. Six-week phone follow-ups were conducted for balance confidence and community integration. Satisfaction with perturbation training was also assessed.ResultsWith no baseline differences between groups (p > 0.075), perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group. Walking-only training in the NonPerturb group (n = 8, pre-crossing) mostly had no effect (p > .292, ES < .26), except on balance confidence (p = .063, ES = .46). The effects of the gait training were still present on balance confidence and community integration at follow-up. Satisfaction with the training program was high.ConclusionIntense and unpredictable gait perturbations have the potential to be an efficient component of training to improve balance abilities and community integration in individuals with chronic stroke. Retrospective registration: ClinicalTrials.gov. March 18th, 2020. Identifier: NCT04314830.

Project description:BackgroundProtocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about lower extremity constraint-induced movement therapy (LE-CIT) and its effects on gait and balance.ObjectiveTo evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke.MethodsThe study adopts a randomized, controlled, single-blinded study design. Forty-two patients, who suffered a stroke, who were in the chronic phase of recovery (>6 months), with gait disability (no community gait), and who were able to walk at least 10 m with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT group or the control group (intensive conventional therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are as follows: 6-min walk test (6minWT), 10-m walk test (10mWT), timed up and go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest), and as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 consecutive days of daily exercise. The participants in the LE-CIT group will be submitted to this protocol 2.5 h/day for 15 consecutive days. It will include (1) intensive supervised training, (2) use of shaping as strategy for motor training, and (3) application of a transfer package (plus 30 min). The control group will receive conventional physiotherapy for 2.5 h/day over 15 consecutive days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups.ResultsData collection is currently on-going and results are expected in 2021.DiscussionLE-CIT seems to be a good protocol for inclusion into stroke survivors' rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities.Trial registrationwww.ensaiosclinicos.gov.br RBR-467cv6 . Registered on 10 October 2017. "Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients".

Project description:Objective: The purpose of this study was to determine the effects of underwater treadmill gait training with water-jet resistance and underwater treadmill gait training with ankle weights on balance and gait abilities in chronic stroke patients. Methods: Twenty-two inpatients and outpatients with stroke-induced impairments were randomly assigned into two groups: an underwater treadmill gait training with water-jet resistance group (n = 11) and an underwater treadmill gait training with ankle weights group (n = 11). Participants received conventional physical therapy for 30 min and underwater treadmill gait training with water-jet resistance or ankle weights for 30 min. Intervention was performed 5 days a week for 4 weeks. The Balance System SD was used to assess static and dynamic balance. The GAITRite system was used to assess gait velocity, cadence, step length, stride length, and swing phase. All measurements were performed at the beginning of the study and 4 weeks after the intervention. Results: The water-jet resistance group and ankle weights group showed significant improvement in static balance (P < 0.00 vs. P = 0.01), dynamic balance (P < 0.00 vs. P = 0.57), gait velocity (P < 0.00 vs. P = 0.037), cadence (P < 0.00 vs. P = 0.001), step length (P < 0.00 vs. P = 0.003), stride length (P < 0.00 vs. P = 0.023), and swing phase (P < 0.00 vs. P < 0.00). However, the static and dynamic balance ability score (P < 0.00), gait velocity (P < 0.00), cadence (P < 0.00), step length (P < 0.00), stride length (P < 0.00), and swing phase (P = 0.023) in the group that received underwater treadmill gait training with water-jet resistance improved more than in the group that received underwater treadmill gait training with ankle weights. Conclusions: Our results demonstrated that underwater treadmill gait training with water-jet resistance is effective in improving static and dynamic balance as well as gait abilities in chronic stroke patients. Thus, training using underwater treadmill gait training with water-jet resistance may be useful in facilitating active rehabilitation in chronic stroke patients.

Project description:BackgroundRegaining gait capacity is an important rehabilitation goal post stroke. Compared to clinically available robotic gait trainers, robots with an assist-as-needed approach and multiple degrees of freedom (AANmDOF) are expected to support motor learning, and might improve the post-stroke gait pattern. However, their benefits compared to conventional gait training have not yet been shown in a randomized controlled trial (RCT). The aim of this two-center, assessor-blinded, RCT was to compare the effect of AANmDOF robotic to conventional training on the gait pattern and functional gait tasks during post-stroke inpatient rehabilitation.MethodsThirty-four participants with unilateral, supratentorial stroke were enrolled (< 10 weeks post onset, Functional Ambulation Categories 3-5) and randomly assigned to six weeks of AANmDOF robotic (combination of training in LOPES-II and conventional gait training) or conventional gait training (30 min, 3-5 times a week), focused on pre-defined training goals. Randomization and allocation to training group were carried out by an independent researcher. External mechanical work (WEXT), spatiotemporal gait parameters, gait kinematics related to pre-defined training goals, and functional gait tasks were assessed before training (T0), after training (T1), and at 4-months follow-up (T2).ResultsTwo participants, one in each group, were excluded from analysis because of discontinued participation after T0, leaving 32 participants (AANmDOF robotic n = 17; conventional n = 15) for intention-to-treat analysis. In both groups, WEXT had decreased at T1 and had become similar to baseline at T2, while gait speed had increased at both assessments. In both groups, most spatiotemporal gait parameters and functional gait tasks had improved at T1 and T2. Except for step width (T0-T1) and paretic step length (T0-T2), there were no significant group differences at T1 or T2 compared to T0. In participants with a pre-defined goal aimed at foot clearance, paretic knee flexion improved more in the AANmDOF robotic group compared to the conventional group (T0-T2).ConclusionsGenerally, AANmDOF robotic training was not superior to conventional training for improving gait pattern in subacute stroke survivors. Both groups improved their mechanical gait efficiency. Yet, AANmDOF robotic training might be more effective to improve specific post-stroke gait abnormalities such as reduced knee flexion during swing. Trial registration Registry number Netherlands Trial Register ( www.trialregister.nl ): NTR5060. Registered 13 February 2015.

Project description:ObjectivesInvestigating the efficacy and safety of noninvasive cerebellar stimulation in improving the balance and walking function of patients with stroke.MethodsWe searched 7 databases for randomized controlled trials (RCTs) related to noninvasive cerebellar stimulation in the treatment of stroke. The Berg Balance Scale (BBS), 6-minute walk test (6MWT), and Barthel Index (BI) were used as the outcome indexes to evaluate balance, walking and activities of daily living (ADL). The quality of the research was evaluated using the Cochrane Risk of Bias Tool. A meta-analysis was performed to evaluate the difference between the noninvasive cerebellar stimulation and control groups. Heterogeneity tests were performed to assess differences in treatment effects across noninvasive cerebellar stimulation modalities. A sensitivity analysis was performed to evaluate the robustness of the results.ResultsSeven studies were included, and 5 articles (71.43%) were rated as having a low risk of bias. Among the primary outcome indicators, 4 of the 7 articles were combined into the fixed effect model (I2 = 38%, P = .18). Compared with the control group, noninvasive cerebellar stimulation improved the BBS score, and the difference was statistically significant (mean difference [MD]: 3.00, 95% confidence interval [CI]: 1.10-5.40, P = .03); the sensitivity analysis showed that the statistical model was still stable after sequentially eliminating each article. Compared with the control group, noninvasive cerebellar stimulation improved the 6MWT results of patients with stroke (MD: 25.29, 95% CI: 4.86-45.73, P = .02). However, noninvasive cerebellar stimulation did not improve the BI (MD: 15.61, 95% CI: -7.91 to 39.13, P = .19). No safety problems or adverse reactions to noninvasive cerebellar stimulation were observed.ConclusionsNoninvasive cerebellar stimulation improves balance and walking function of patients with stroke, but its effect on ADL is uncertain. Due to the methodological weaknesses in the included trials, more RCTs are needed to confirm our conclusions.

Dataset Information

Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial.

Publications

Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial.

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