Dataset Information

Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial.

ABSTRACT: Over the last years, the introduction of robotic technologies into Parkinson's disease rehabilitation settings has progressed from concept to reality. However, the benefit of robotic training remains elusive. This pilot randomized controlled observer trial is aimed at investigating the feasibility, the effectiveness and the efficacy of new end-effector robot training in people with mild Parkinson's disease.Design. Pilot randomized controlled trial.Robot training was feasible, acceptable, safe, and the participants completed 100% of the prescribed training sessions. A statistically significant improvement in gait index was found in favour of the EG (T0 versus T1). In particular, the statistical analysis of primary outcome (gait speed) using the Friedman test showed statistically significant improvements for the EG (p?=?0,0195). The statistical analysis performed by Friedman test of Step length left (p?=?0,0195) and right (p?=?0,0195) and Stride length left (p?=?0,0078) and right (p?=?0,0195) showed a significant statistical gain. No statistically significant improvements on the CG were found.Robot training is a feasible and safe form of rehabilitative exercise for cognitively intact people with mild PD. This original approach can contribute to increase a short time lower limb motor recovery in idiopathic PD patients. The focus on the gait recovery is a further characteristic that makes this research relevant to clinical practice. On the whole, the simplicity of treatment, the lack of side effects, and the positive results from patients support the recommendation to extend the use of this treatment. Further investigation regarding the long-time effectiveness of robot training is warranted.ClinicalTrials.gov NCT01668407.

SUBMITTER: Sale P

PROVIDER: S-EPMC3665527 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial.

Sale Patrizio P De Pandis Maria Francesca MF Le Pera Domenica D Sova Ivan I Cimolin Veronica V Ancillao Andrea A Albertini Giorgio G Galli Manuela M Stocchi Fabrizio F Franceschini Marco M

BMC neurology 20130524

<h4>Background</h4>Over the last years, the introduction of robotic technologies into Parkinson's disease rehabilitation settings has progressed from concept to reality. However, the benefit of robotic training remains elusive. This pilot randomized controlled observer trial is aimed at investigating the feasibility, the effectiveness and the efficacy of new end-effector robot training in people with mild Parkinson's disease.<h4>Methods</h4>Design. Pilot randomized controlled trial.<h4>Results</ ...[more]

PMID: 23706025

Similar Datasets

Project description:BackgroundRobot-assisted gait training (RAGT) was developed to restore gait function by promoting neuroplasticity through repetitive locomotor training and has been utilized in gait training. However, contradictory outcomes of RAGT have been reported for patients with Parkinson's disease (PD). In addition, the mechanism of the RAGT treatment effect is still unknown. This study aims to investigate the effects of RAGT on gait velocity in patients with PD and to unveil the mechanisms of these effects.MethodsThis is a prospective, single-blind, single-center, randomized controlled trial. Eligible participants will be randomly allocated to: 1) a Walkbot-S™ RAGT group or 2) a treadmill training group. The participants will receive three 45-min sessions of each intervention per week for 4 weeks. Gait speed during RAGT will be targeted to the maximal speed depending on the participant's height; the same principle will be applied to the treadmill training group to match the training intensity. The primary outcome measure is gait speed measured by the 10-Meter Walk Test at a comfortable pace under single-task conditions. Secondary outcomes include dual-task interference, the Berg Balance Scale, Timed Up and Go test, the Korean version of the Falls Efficacy Scale-International, New Freezing of Gait Questionnaire, Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, and functional connectivity measured by resting-state functional magnetic resonance imaging. Baseline assessments (T0) will be conducted to acquire clinical characteristics and outcome measure values before the intervention. Postintervention assessments (T1) will compare immediate efficacies within 3 days after the intervention. Follow-up assessments (T2) will be conducted 1 month after the intervention. Considering an alpha of 0.05 and a power of 80%, the total number of participants to be recruited is 44.DiscussionThis study will reveal the effect of RAGT using an exoskeletal robot, not only on gait speed, but also on gait automaticity, balance function, fall risk, quality of life, and disease severity. In addition, the study will shed new light on the mechanism of the RAGT effect by evaluating changes in gait automaticity and brain functional networks.Trial registrationClinicalTrials.gov, NCT03490578 . Registered on 21 March 2018.

Project description:Background and Objectives: Gait disorders represent one of the most disabling aspects in multiple sclerosis (MS) that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. The aim of this study is to evaluate the effectiveness of robot-assisted gait training (RAGT) in association with physiotherapy treatment in patients affected by MS in comparison with ground conventional gait training. Study design: Randomized controlled crossover trial. Materials and Methods: Twenty-seven participants affected by MS with EDSS scores between 3.5 and 7 were enrolled, of whom seventeen completed the study. They received five training sessions per week over five weeks of conventional gait training with (experimental group) or without (control group) the inclusion of RAGT. The patients were prospectively evaluated before and after the first treatment session and, after the crossover phase, before and after the second treatment session. The evaluation was based on the 25-foot walk test (25FW, main outcome), 6 min walk test (6MWT), Tinetti Test, Modified Ashworth Scale, and modified Motricity Index for lower limbs. We also measured disability parameters using Functional Independence Measure and Quality of Life Index, and instrumental kinematic and gait parameters: knee extensor strength, double-time support, step length ratio; 17 patients reached the final evaluation. Results: Both groups significantly improved on gait parameters, motor abilities, and autonomy recovery in daily living activities with generally better results of RAGT over control treatment. In particular, the RAGT group improved more than control group in the 25FW (p = 0.004) and the 6MWT (p = 0.022). Conclusions: RAGT is a valid treatment option that in association with physiotherapy could induce positive effects in MS-correlated gait disorders. Our results showed greater effectiveness in recovering gait speed and resistance than conventional gait training.

Project description:BackgroundType 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM.MethodsA parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention's potential.ResultsForty participants (Mage = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity.ConclusionsThe study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements.Trial registrationISRCTN, ISRCTN67421464 . Registered 17/12/2018.

Project description:BackgroundRobot-assisted ankle-foot-orthosis (AFO) can provide immediate powered ankle assistance in post-stroke gait training. Our research team has developed a novel lightweight portable robot-assisted AFO which is capable of detecting walking intentions using sensor feedback of wearer's gait pattern. This study aims to investigate the therapeutic effects of robot-assisted gait training with ankle dorsiflexion assistance.MethodsThis was a double-blinded randomized controlled trial. Nineteen chronic stroke patients with motor impairment at ankle participated in 20-session robot-assisted gait training for about five weeks, with 30-min over-ground walking and stair ambulation practices. Robot-assisted AFO either provided active powered ankle assistance during swing phase in Robotic Group (n = 9), or torque impedance at ankle joint as passive AFO in Sham Group (n = 10). Functional assessments were performed before and after the 20-session gait training with 3-month Follow-up. Primary outcome measure was gait independency assessed by Functional Ambulatory Category (FAC). Secondary outcome measures were clinical scores including Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Berg Balance Scale (BBS), Timed 10-Meter Walk Test (10MWT), Six-minute Walk Test (SMWT), supplemented by gait analysis. All outcome measures were performed in unassisted gait after patients had taken off the robot-assisted AFO. Repeated-measures analysis of covariance was conducted to test the group differences referenced to clinical scores before training.ResultsAfter 20-session robot-assisted gait training with ankle dorsiflexion assistance, the active ankle assistance in Robotic Group induced changes in gait pattern with improved gait independency (all patients FAC ≥ 5 post-training and 3-month follow-up), motor recovery, walking speed, and greater confidence in affected side loading response (vertical ground reaction force + 1.49 N/kg, peak braking force + 0.24 N/kg) with heel strike instead of flat foot touch-down at initial contact (foot tilting + 1.91°). Sham Group reported reduction in affected leg range of motion (ankle dorsiflexion - 2.36° and knee flexion - 8.48°) during swing.ConclusionsRobot-assisted gait training with ankle dorsiflexion assistance could improve gait independency and help stroke patients developing confidence in weight acceptance, but future development of robot-assisted AFO should consider more lightweight and custom-fit design.Trial registrationClinicalTrials.gov NCT02471248 . Registered 15 June 2015 retrospectively registered.

Dataset Information

Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial.

Publications

Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets