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 Hybrid Robot-Assisted Gait Training for Motor Function in Subacute Stroke: A Single-Blind Randomized Controlled Trial

2021 ◽  
Author(s):  
Yen-Nung Lin ◽  
Shih-Wei Huang ◽  
Yi-Chun Kuan ◽  
Hung-Chou Chen ◽  
Wen-Shan Jian ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lower Extremity ◽  
Controlled Trial ◽  
Gait Training ◽  
The Novel ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Subacute Stroke ◽  
Before And After

Abstract Background:Robot-assisted gait training (RAGT) is a practical treatment adjunctive to conventional rehabilitation to provide high-intensity repetitive training for patients with stroke. The robot models designed are usually either the end-effector type or the exoskeleton type. We developed a novel hybrid RAGT system that combines the advantages of both types.Objective:This randomized controlled trial (RCT) evaluated whether the novel RAGT system was beneficial and assessed long-term effects (at the 3-month follow-up) for nonambulatory patients with subacute stroke.Methods:This trial recruited 40 patients with subacute stroke who were equally randomized to receive conventional rehabilitation or 15 add-on RAGT sessions. We assessed lower-extremity motor function, balance, and gait performance by using the following tools: active range of motion (AROM), manual muscle test (MMT), the Fugl-Meyer Assessment (FMA) lower-extremity subscale (FMA-LE) and total (FMA-total), Postural Assessment Scale for Stroke (PASS), Berg Balance Scale (BBS), Tinetti Performance Oriented Mobility Assessment (POMA) balance and gait subscores, and the 3- and 6-m walking speed and Timed Up and Go (TUG) tests. These measurements were performed before and after the intervention and at the 3-month follow-up.Results:Both groups demonstrated significant within-group changes in the AROM, MMT, FMA-LE, FMA-total, PASS, BBS, POMA, TUG, and 3- and 6-m walking speeds before and after intervention and at the 3-month follow-up (p < 0.05). Only FMA-LE (p = 0.014) and total (p = 0.002) scores differed significantly between groups (RAGT vs. control).Conclusion:Although the novel hybrid RAGT was beneficial, no powerful evidence to supported its effectiveness relative to the control group in substantial leg dysfunction after stroke.Trial Registration: The study was registered with an International Standard Randomized Controlled Trial Number, ISRCTN, ISRCTN15088682. Registered 16 September 2016, Retrospectively registered https://www.isrctn.com/ISRCTN15088682

scholarly journals Pivotal Response Treatment with and without robot-assistance for children with autism: a randomized controlled trial

2021 ◽  
Author(s):  
Iris van den Berk-Smeekens ◽  
Manon W. P. de Korte ◽  
Martine van Dongen-Boomsma ◽  
Iris J. Oosterling ◽  
Jenny C. den Boer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Pivotal Response Treatment ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Children With Asd ◽  
Robot Assistance

AbstractPivotal response treatment (PRT) is a promising intervention focused on improving social communication skills in children with autism spectrum disorder (ASD). Since robots potentially appeal to children with ASD and may contribute to their motivation for social interaction, this exploratory randomized controlled trial (RCT) was conducted comparing PRT (PRT and robot-assisted PRT) with treatment-as-usual (TAU). Seventy-three children (PRT: n = 25; PRT + robot: n = 25; TAU: n = 23) with ASD, aged 3–8 years were assessed at baseline, after 10 and 20 weeks of intervention, and at 3-month follow-up. There were no significant group differences on parent- and teacher-rated general social-communicative skills and blindly rated global functioning directly after treatment. However, at follow-up largest gains were observed in robot-assisted PRT compared to other groups. These results suggest that robot-assistance may contribute to intervention efficacy for children with ASD when using game scenarios for robot-child interaction during multiple sessions combined with motivational components of PRT. This trial is registered at https://www.trialregister.nl/trial/4487; NL4487/NTR4712 (2014-08-01).

scholarly journals Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder

2019 ◽  
Vol 22 (9) ◽  
pp. 1543-1552 ◽  
Author(s):  
Jaimee L Heffner ◽  
Megan M Kelly ◽  
Jeanette Waxmonsky ◽  
Kristin Mattocks ◽  
Edit Serfozo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Trial Design ◽  
Nicotine Patch ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
Acceptance And Commitment ◽  
End Of Treatment ◽  
Pilot Randomized Controlled Trial

Abstract Introduction Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability. Aims and Methods Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions—ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up. Results We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms. Conclusions Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation. Implications In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.

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