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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

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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

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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:BACKGROUND:Robot-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. METHODS:This 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. RESULTS:After 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. CONCLUSIONS:Robot-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 REGISTRATION:ClinicalTrials.gov NCT02471248 . Registered 15 June 2015 retrospectively registered.

Project description:BACKGROUND:Laparoscopic surgery potentially increases the physical burden to operating theater personnel and can cause physical discomfort. This study aims to evaluate if a robotic camera holder (AutoLap™ system) can improve ergonomics for the surgeon and the camera assistant during laparoscopic procedures. METHODS:A total of thirty cases were included and randomized (15 AutoLap™, 15 control). Five types of surgery were included: right hemicolectomy, fundoplication, sigmoid resection, rectopexy, and low anterior resection. The posture of the surgeon and assistant was photographed during predefined steps of the procedure. MATLAB was used to calculate angles relevant for the RULA score. The RULA score is a validated method to evaluate body posture, force and repetition of the upper extremities. Two investigators assessed the RULA score independently. Three subjective questionnaires (SMEQ, NASA TLX, and LED) were used to assess mental and physical discomfort. RESULTS:No differences in patient characteristics were observed. Sixteen fundoplications, seven right hemicolectomies, five sigmoid resections, one rectopexy, and one low anterior resection were included. The mean RULA score of the surgeon was comparable in both groups, 2.58 (AutoLap™) versus 2.72 (control). The mean RULA score of the assistant was significantly different in both groups, with 2.55 (AutoLap™) versus 3.70 (control) (p?=?0.001). The inter-observer variability (ICC) was excellent with 0.93 (surgeon) and 0.97 (assistant). The questionnaires showed a significant difference in physical discomfort for the assistant. The LED and SMEQ score were significantly lower in the robotic group. The NASA TLX demonstrated a significant reduction in scores in all domains when using robotics with the exception of the mental domain. CONCLUSION:Use of the AutoLap™ system shows improvement in ergonomics and posture of the first assistant, and ergonomics of the surgeon are not affected. Furthermore, the subjective work load is significantly reduced by using a robotic camera holder. TRIAL REGISTRATION NUMBER:NCT0339960, https://clinicaltrials.gov/ct2/show/study/NCT03339960?term=autolap&rank=5 .

Project description:Despite the functional impact of upper limb dysfunction in multiple sclerosis (MS), effects of intensive exercise programs and specifically robot-supported training have been rarely investigated in persons with advanced MS.To investigate the effects of additional robot-supported upper limb training in persons with MS compared to conventional treatment only.Seventeen persons with MS (pwMS) (median Expanded Disability Status Scale of 8, range 3.5-8.5) were included in a pilot RCT comparing the effects of additional robot-supported training to conventional treatment only. Additional training consisted of 3 weekly sessions of 30 min interacting with the HapticMaster robot within an individualised virtual learning environment (I-TRAVLE). Clinical measures at body function (Hand grip strength, Motricity Index, Fugl-Meyer) and activity (Action Research Arm test, Motor Activity Log) level were administered before and after an intervention period of 8 weeks. The intervention group were also evaluated on robot-mediated movement tasks in three dimensions, providing active range of motion, movement duration and speed and hand-path ratio as indication of movement efficiency in the spatial domain. Non-parametric statistics were applied.PwMS commented favourably on the robot-supported virtual learning environment and reported functional training effects in daily life. Movement tasks in three dimensions, measured with the robot, were performed in less time and for the transporting and reaching movement tasks more efficiently. There were however no significant changes for any clinical measure in neither intervention nor control group although observational analyses of the included cases indicated large improvements on the Fugl-Meyer in persons with more marked upper limb dysfunction.Robot-supported training lead to more efficient movement execution which was however, on group level, not reflected by significant changes on standard clinical tests. Persons with more marked upper limb dysfunction may benefit most from additional robot-supported training, but larger studies are needed.This trial is registered within the registry Clinical Trials GOV ( NCT02257606 ).

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

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

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