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The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial.

ABSTRACT: Gait and mobility impairments affect the quality of life (QoL) of patients with progressive multiple sclerosis (MS). Robot-assisted gait training (RAGT) is an effective rehabilitative treatment but evidence of its superiority compared to other options is lacking. Furthermore, the response to rehabilitation is multidimensional, person-specific and possibly involves functional reorganization processes. The aims of this study are: (1) to test the effectiveness on gait speed, mobility, balance, fatigue and QoL of RAGT compared to conventional therapy (CT) in progressive MS and (2) to explore changes of clinical and circulating biomarkers of neural plasticity.This will be a parallel-group, randomized controlled trial design with the assessor blinded to the group allocation of participants. Ninety-eight (49 per arm) progressive MS patients (EDSS scale 6-7) will be randomly assigned to receive twelve 2-h training sessions over a 4-week period (three sessions/week) of either: (1) RAGT intervention on a robotic-driven gait orthosis (Lokomat, Hocoma, Switzerland). The training parameters (torque of the knee and hip drives, treadmill speed, body weight support) are set during the first session and progressively adjusted during training progression or (2) individual conventional physiotherapy focusing on over-ground walking training performed with the habitual walking device. The same assessors will perform outcome measurements at four time points: baseline (before the first intervention session); intermediate (after six training sessions); end of treatment (after the completion of 12 sessions); and follow-up (after 3 months from the end of the training program). The primary outcome is gait speed, assessed by the Timed 25-Foot Walk Test. We will also assess walking endurance, balance, depression, fatigue and QoL as well as instrumental laboratory markers (muscle metabolism, cerebral venous hemodynamics, cortical activation) and circulating laboratory markers (rare circulating cell populations pro and anti-inflammatory cytokines/chemokines, growth factors, neurotrophic factors, coagulation factors, other plasma proteins suggested by transcriptomic analysis and metabolic parameters).The RAGT training is expected to improve mobility compared to the active control intervention in progressive MS. Unique to this study is the analysis of various potential markers of plasticity in relation with clinical outcomes.ClinicalTrials.gov, identifier: NCT02421731 . Registered on 19 January 2015 (retrospectively registered).

SUBMITTER: Straudi S

PROVIDER: S-EPMC5330064 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial.

Straudi Sofia S Manfredini Fabio F Lamberti Nicola N Zamboni Paolo P Bernardi Francesco F Marchetti Giovanna G Pinton Paolo P Bonora Massimo M Secchiero Paola P Tisato Veronica V Volpato Stefano S Basaglia Nino N

Trials 20170227 1

<h4>Background</h4>Gait and mobility impairments affect the quality of life (QoL) of patients with progressive multiple sclerosis (MS). Robot-assisted gait training (RAGT) is an effective rehabilitative treatment but evidence of its superiority compared to other options is lacking. Furthermore, the response to rehabilitation is multidimensional, person-specific and possibly involves functional reorganization processes. The aims of this study are: (1) to test the effectiveness on gait speed, mobi ...[more]

PMID: 28241776

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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: The limitation to the use of ElectroMyoGraphy (sEMG) in rehabilitation services is in contrast with its potential diagnostic capacity for rational planning and monitoring of the rehabilitation treatments, especially the overground Robot-Assisted Gait Training (o-RAGT). Objective: To assess the barriers to the implementation of a sEMG-based assessment protocol in a clinical context for evaluating the effects of o-RAGT in subacute stroke patients. Methods: An observational study was conducted in a rehabilitation hospital. The primary outcome was the success rate of the implementation of the sEMG-based assessment. The number of dropouts and the motivations have been registered. A detailed report on difficulties in implementing the sEMG protocol has been edited for each patient. The educational level and the working status of the staff have been registered. Each member of staff completed a brief survey indicating their level of knowledge of sEMG, using a five-point Likert scale. Results: The sEMG protocol was carried out by a multidisciplinary team composed of Physical Therapists (PTs) and Biomedical Engineers (BEs). Indeed, the educational level and the expertise of the members of staff influenced the fulfillment of the implementation of the study. The PTs involved in the study did not receive any formal education on sEMG during their course of study. The low success rate (22.7%) of the protocol was caused by several factors which could be grouped in: patient-related barriers; cultural barriers; technical barriers; and administrative barriers. Conclusions: Since a series of barriers limited the use of sEMG in the clinical rehabilitative environment, concrete actions are needed for disseminating sEMG in rehabilitation services. The sEMG assessment should be included in health systems regulations and specific education should be part of the rehabilitation professionals' curriculum. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03395717.

Project description:BackgroundWalking impairment represents a relevant symptom in patients with neurological diseases often compromising social participation. Currently, mixed methods studies on robot-assisted gait training (RAGT) in patients with rare neurological diseases are lacking. This study aimed to explore the feasibility, acceptability, goal attainment and preliminary effects of RAGT in patients with common and rare neurological diseases and understand the intervention context and process.MethodsA mixed-methods feasibility study was conducted at an Austrian rehabilitation centre. Twenty-eight inpatients after stroke in the subacute and chronic phases, with multiple sclerosis, Parkinson's disease, spinal cord injury, spinocerebellar ataxia, acute/chronic inflammatory demyelinating polyneuropathy and motor neuron disease were included. Patients received RAGT for 45 minutes, 4x/week, for 4 weeks. Baseline and post-intervention assessments included gait parameters, walking and balance, and questionnaires. Semi-structured observations were conducted twice during the intervention period and analysed using thematic analysis. Descriptive statistics within the respective disease groups and calculation of effect sizes for the total sample were performed. Triangulation was employed to develop a deeper understanding of the research topic.ResultsData from 26 patients (mean age 61.6 years [standard deviation 13.2]) were analysed. RAGT was highly accepted by patients and feasible, indicated by recruitment, retention, and adherence rates of 84.8% (95% confidence interval, CI 0.7-0.9), 92.2% (95% CI 0.7-1.0) and 94.0% (95% CI 91.4-96.2), respectively. Goal attainment was high, and only mild adverse events occurred. Improvements in walking speed (10-Metre Walk Test, effect size r = 0.876), walking distance (6-Minute Walk Test, r = 0.877), functional mobility (Timed Up and Go, r = 0.875), gait distance (r = 0.829) and number of steps (r = 0.834) were observed. Four themes were identified: familiarising with RAGT; enjoyment and acceptance through a trusting therapeutic relationship; actively interacting; and minimising dissatisfaction.DiscussionSufficiently powered randomised controlled trials are needed to validate our results.Trial registrationGerman Clinical Trials Register, DRKS00027887.

Project description:AbstractGait automaticity is reduced in patients with Parkinson disease (PD) due to impaired habitual control. The aim of this study was to investigate the effect of robot-assisted gait training (RAGT) on gait automaticity as well as gait speed and balance in patients with PD.This study was a prospective, open-label, single-arm, pilot study. We planned to recruit 12 patients with idiopathic PD. Participants received 12 sessions of RAGT using exoskeleton-type robotic device. Sessions were 45-minute each, 3 days a week, for 4 consecutive weeks using an exoskeleton-type gait robot. The primary outcome was the percentage of dual-task interference measured by the 10-Meter Walk Test (10MWT) under single and dual-task (cognitive and physical) conditions. Secondary outcomes were the Berg Balance Scale and Korean version of the Falls Efficacy Scale-International. All measures were evaluated before treatment (T0), after treatment (T1), and 1-month post-treatment (T2).Twelve patients were enrolled and 1 dropped out. Finally, 11 patients with idiopathic PD were analyzed. The mean age of 11 patients (5 males) was 66.46 ± 5.66 years, and disease duration was 112.91 ± 50.19 months. The Hoehn and Yahr stages were 2.5 in 8 patients and 3 in 3 patients. Linear mixed-effect model analysis showed a significant change over time only in single-task gait speed of the 10MWT (P = .007), but not in dual-task gait speed, dual-task interferences, and Korean version of the Falls Efficacy Scale-International. Cognitive dual-task interference significantly increased (P = .026) at T1, but not at T2 (P = .203). No significant changes were observed for physical dual-task interference at T1 and T2. Single-task gait speed of the 10MWT was significantly increased at T1 (P = .041), but not at T2 (P = .445). There were no significant changes in the dual-task gait speed of 10MWT. A significant improvement was observed in Berg Balance Scale score at T1 and T2 (P = .004 and P = .024, respectively).In this pilot study, despite improvement in walking speed and balance, gait automaticity in patients with PD was not improved by RAGT using an exoskeleton-type robot. Additional therapeutic components may be needed to improve gait automaticity using RAGT in patients with PD.

Dataset Information

The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial.

Publications

The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial.

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