Does robot-assisted gait training improve ambulation in highly disabled multiple sclerosis people? A pilot randomized control trial

2016 ◽  
Vol 23 (5) ◽  
pp. 696-703 ◽  
Author(s):  
Alessandra Pompa ◽  
Giovanni Morone ◽  
Marco Iosa ◽  
Luca Pace ◽  
Sheila Catani ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gait Training ◽  
Control Group ◽  
Robot Assisted ◽  
Robotic Training ◽  
Global Mobility ◽  
Pilot Randomized Control Trial

Background: Robotic training is commonly used to assist walking training in patients affected by multiple sclerosis (MS) with non-conclusive results. Objective: To compare the effect of robot-assisted gait training (RAGT) with that of conventional walking training (CWT) on gait competencies, global ability, fatigue and spasticity in a group of severely affected patients with MS. Methods: A pilot, single-blind randomized controlled trial was conducted in 43 severe (Expanded Disability Status Scale (EDSS) score of 6–7.5) and non-autonomous ambulant in-patients with MS. Experimental group performed 12 sessions of RAGT, whereas control group performed the same amount of CWT. Primary outcome measures were gait ability assessed by 2 minutes walking test and Functional Ambulatory Category; secondary outcomes were global ability (modified Barthel Index), global mobility (Rivermead Mobility Index), severity of disease (EDSS) and subjectively perceived fatigue (Fatigue Severity Scale). Results: The number of subjects who achieved a clinical significant improvement was significantly higher in RAGT than in CWT ( p < 0.05 for both primary outcome measures). RAGT also led to an improvement in all the other clinical parameters (global ability: p < 0.001, global mobility: p < 0.001, EDSS: p = 0.014 and fatigue: p = 0.001). Conclusions: RAGT improved the walking competencies in non-autonomous ambulant patients with MS, with benefits in terms of perceived fatigue.

Facilitating access to iCBT: a randomized controlled trial assessing a translated version of an empirically validated program using a minimally monitored delivery model

2019 ◽  
Vol 48 (2) ◽  
pp. 185-202
Author(s):  
Miguel Robichaud ◽  
France Talbot ◽  
Nickolai Titov ◽  
Blake F. Dear ◽  
Heather D. Hadjistavropoulos ◽  
...  
Keyword(s):  
Treatment Group ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Anxiety And Depression ◽  
Control Group ◽  
Access To Treatment ◽  
Delivery Model

AbstractBackground:Despite its established efficacy, access to internet-delivered CBT (iCBT) remains limited in a number of countries. Translating existing programs and using a minimally monitored model of delivery may facilitate its dissemination across countries.Aims:This randomized control trial aims to evaluate the efficacy of an iCBT transdiagnostic program translated from English to French and offered in Canada using a minimally monitored delivery model for the treatment of anxiety and depression.Method:Sixty-three French speakers recruited in Canada were randomized to iCBT or a waiting-list. A French translation of an established program, the Wellbeing Course, was offered over 8 weeks using a minimally monitored delivery model. Primary outcome measures were the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9), which were obtained pre-treatment, post-treatment and at 3-month follow-up.Results:Mixed-effects models revealed that participants in the treatment group had significantly lower PHQ-9 and GAD-7 scores post-treatment than controls with small between-groups effect sizes (d = 0.34 and 0.37, respectively). Within-group effect sizes on primary outcome measures were larger in the treatment than control group. Clinical recovery rates on the PHQ-9 and GAD-7 were significantly higher among the treatment group (40 and 56%, respectively) than the controls (13 and 16%, respectively).Conclusions:The provision of a translated iCBT program using a minimally monitored delivery model may improve patients’ access to treatment of anxiety and depression across countries. This may be an optimal first step in improving access to iCBT before sufficient resources can be secured to implement a wider range of iCBT services.

scholarly journals Robot-assisted gait training to reduce pusher behavior

Neurology ◽  
2018 ◽  
Vol 91 (14) ◽  
pp. e1319-e1327 ◽  
Author(s):  
Jeannine Bergmann ◽  
Carmen Krewer ◽  
Klaus Jahn ◽  
Friedemann Müller
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Gait Training ◽  
Class Ii ◽  
Control Group ◽  
Robot Assisted ◽  
Post Intervention ◽  
Subacute Stroke ◽  
Post Test

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.

Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial

2019 ◽  
Vol 26 (6) ◽  
pp. 716-724 ◽  
Author(s):  
Sofia Straudi ◽  
Fabio Manfredini ◽  
Nicola Lamberti ◽  
Carlotta Martinuzzi ◽  
Elisa Maietti ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Gait Speed ◽  
Controlled Trial ◽  
Gait Training ◽  
Overground Walking ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
End Of Treatment

Background: Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities. Objective: In this randomized controlled trial, we compared robot-assisted gait training (RAGT) with conventional therapy (CT) in terms of gait speed, mobility, balance, fatigue and quality of life (QoL). Methods: Seventy-two patients with MS (expanded disability status scale score 6.0–7.0) were randomized to receive 12 training sessions over a 4-week period of RAGT ( n = 36) or overground walking therapy ( n = 36). The primary outcome was gait speed, assessed by the timed 25-foot walk test. Secondary outcome measures were walking endurance, balance, depression, fatigue and QoL. Tests were performed at baseline, intermediate, at the end of treatment and at a 3-month follow-up. Results: Sixty-six patients completed the treatments. At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences. Outcome values returned to baseline at follow-up. Conclusions: RAGT was not superior to CT in improving gait speed in patients with progressive MS and severe gait disabilities where a positive, even transitory, effect of rehabilitation was observed.

scholarly journals Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates

2021 ◽  
pp. 1-14
Author(s):  
Leena Subramanian ◽  
Leon Skottnik ◽  
W. Miles Cox ◽  
Michael Lührs ◽  
Rachel McNamara ◽  
...  
Keyword(s):  
Treatment Group ◽  
Alcohol Dependence ◽  
Outcome Measures ◽  
Standard Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Salience Network ◽  
Neurofeedback Training

Introduction: Alcohol dependence is one of the most common substance use disorders, and novel treatment options are urgently needed. Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf­MRI) has emerged as an attractive candidate for add-on treatments in psychiatry, but its use in alcohol dependence has not been formally investigated in a clinical trial. We investigated the use of rtfMRI-based NFT to prevent relapse in alcohol dependence. Methods: Fifty-two alcohol-dependent patients from the UK who had completed a detoxification program were randomly assigned to a treatment group (receiving rtfMRI NFT in addition to standard care) or the control group (receiving standard care only). At baseline, alcohol consumption was assessed as the primary outcome measure and a variety of psychological, behavioral, and neural parameters as secondary outcome measures to determine feasibility and secondary training effects. Participants in the treatment group underwent 6 NFT sessions over 4 months and were trained to downregulate their brain activation in the salience network in the presence of alcohol stimuli and to upregulate frontal activation in response to pictures related to positive goals. Four, 8, and 12 months after baseline assessment, both groups were followed up with a battery of clinical and psychometric tests. Results: Primary outcome measures showed very low relapse rates for both groups. Analysis of neural secondary outcome measures indicated that the majority of patients modulated the salience system in the desired directions, by decreasing activity in response to alcohol stimuli and increasing activation in response to positive goals. The intervention had a good safety and acceptability profile. Conclusion: We demonstrated that rtfMRI-neurofeedback targeting hyperactivity of the salience network in response to alcohol cues is feasible in currently abstinent patients with alcohol dependence.

Robot-assisted gait training in multiple sclerosis patients: a randomized trial

2011 ◽  
Vol 18 (6) ◽  
pp. 881-890 ◽  
Author(s):  
Isabella Schwartz ◽  
Anna Sajin ◽  
Elior Moreh ◽  
Iris Fisher ◽  
Martin Neeb ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Gait Training ◽  
Post Treatment ◽  
Robot Assisted ◽  
Neurologically Impaired ◽  
Gait Parameters ◽  
Prospective Randomized Controlled Trial ◽  
Multiple Sclerosis Patients

Background: Preservation of locomotor activity in multiple sclerosis (MS) patients is of utmost importance. Robotic-assisted body weight-supported treadmill training is a promising method to improve gait functions in neurologically impaired patients, although its effectiveness in MS patients is still unknown. Objective: To compare the effectiveness of robot-assisted gait training (RAGT) with that of conventional walking treatment (CWT) on gait and generalized functions in a group of stable MS patients. Methods: A prospective randomized controlled trial of 12 sessions of RAGT or CWT in MS patients of EDSS score 5–7. Primary outcome measures were gait parameters and the secondary outcomes were functional and quality of life parameters. All tests were performed at baseline, 3 and 6 months post-treatment by a blinded rater. Results: Fifteen and 17 patients were randomly allocated to RAGT and CWT, respectively. Both groups were comparable at baseline in all parameters. As compared with baseline, although some gait parameters improved significantly following the treatment at each time point there was no difference between the groups. Both FIM and EDSS scores improved significantly post-treatment with no difference between the groups. At 6 months, most gait and functional parameters had returned to baseline. Conclusions: Robot-assisted gait training is feasible and safe and may be an effective additional therapeutic option in MS patients with severe walking disabilities.

Digital Technology in Clinical Trials for Multiple Sclerosis: a systematic review. (Preprint)

2020 ◽  
Author(s):  
Marcello De Angelis ◽  
Luigi Lavorgna ◽  
Antonio Carotenuto ◽  
Martina Petruzzo ◽  
Roberta Lanzillo ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Digital Technology ◽  
Clinical Trial Design ◽  
Motor Rehabilitation ◽  
Robot Assisted ◽  
Future Directions ◽  
Treatment Side Effects

BACKGROUND Clinical trials in multiple sclerosis (MS) have leveraged the use of digital technology to overcome limitations in treatment and disease monitoring. OBJECTIVE To review the use of digital technology in concluded and ongoing MS clinical trials. METHODS In March 2020, we searched for “multiple sclerosis” and “trial” on pubmed.gov and clinicaltrials.gov using “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Overall, we included thirty-five studies. RESULTS Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Also, digital technology has become increasingly used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms. Some trials have been developing new patient-centred outcome measures for the detection of symptoms and of treatment side effects and adherence. CONCLUSIONS We will discuss how digital technology has been changing MS clinical trial design, and possible future directions for MS and neurology research.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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