scholarly journals Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial

Medicina ◽  
2021 ◽  
Vol 57 (7) ◽  
pp. 713
Author(s):  
Cristiano Sconza ◽  
Francesco Negrini ◽  
Berardo Di Matteo ◽  
Alberto Borboni ◽  
Gennaro Boccia ◽  
...  
Keyword(s):  
Crossover Trial ◽  
Gait Training ◽  
Treatment Session ◽  
Control Group ◽  
Walk Test ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Before And After

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.

scholarly journals Pulmonary rehabilitation to improve physical capacity, dyspnea and quality of life following pulmonary embolism (the PeRehab study): Study protocol for a two-centre randomized controlled trial

2020 ◽  
Author(s):  
Stacey Haukeland-Parker ◽  
Øyvind Jervan ◽  
Hege Hølmo Johannessen ◽  
Jostein Gleditsch ◽  
Knut Stavem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Physical Capacity ◽  
Control Group ◽  
Walk Test ◽  
Randomized Controlled

Abstract Background: Recently, a large group of patients with persistent dyspnea, poor physical capacity and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name “post pulmonary embolism syndrome” (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea and HRQoL in PPS patients.Methods: A two-centre randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 hour) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise.Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the Modified Medical Research Council scale, the Shortness of Breath questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL).Recruitment of 190 patients is currently ongoing.Discussion: Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity and better HRQoL following PE.Trial registration: NCT03405480, Clinical Trials (registered prospectively.Protocol version 1 (from original protocol September 2017).The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

scholarly journals Effects of visualization of successful revascularization on chest pain and quality of life in chronic coronary syndrome: study protocol for the multi-center, randomized, controlled PLA-pCi-EBO-pilot-trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Michael Wester ◽  
Franziska Koll ◽  
Florian Zeman ◽  
Astrid Dempfle ◽  
Michael Koller ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Daily Routine ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
Before And After ◽  
Stable Cad

Abstract Background Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS. Design and methods The PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI. Discussion The PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory. Trial registration German Clinical Trials Register DRKS00017524. Registered on 5 July 2019

scholarly journals Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke–A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up

2021 ◽  
Vol 15 ◽  
Author(s):  
Susanne Palmcrantz ◽  
Anneli Wall ◽  
Katarina Skough Vreede ◽  
Påvel Lindberg ◽  
Anna Danielsson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Gait Training ◽  
Conventional Group ◽  
Control Group ◽  
Walk Test ◽  
Post Intervention ◽  
Randomized Controlled

Introduction: Movement related impairments and limitations in walking are common long-term after stroke. This multi-arm randomized controlled trial explored the impact of training with an electromechanically assisted gait training (EAGT) system, i.e., the Hybrid Assistive Limb® (HAL), when integrated with conventional rehabilitation focused on gait and mobility.Material and Methods: Participants, aged 18–70 years with lower extremity paresis but able to walk with manual support or supervision 1–10 years after stroke, were randomized to (A) HAL-training on a treadmill, combined with conventional rehabilitation interventions (HAL-group), or (B) conventional rehabilitation interventions only (Conventional group), 3 days/week for 6 weeks, or (C) no intervention (Control group). Participants in the Control group were interviewed weekly regarding their scheduled training. Primary outcome was endurance in walking quantified by the 6 Minute Walk Test (6MWT). A rater blinded to treatment allocation performed assessments pre- and post-intervention and at follow-ups at 6 and 12 months. Baseline assessment included the National Institute of Health Stroke Scale (NIHSS) and the Modified Ranking Scale (MRS). Secondary outcomes included the Fugl Meyer Assessment- Lower Extremity, 10 Meter Walk Test, Berg Balance Scale (BBS), Barthel Index (BI) and perceived mobility with the Stroke Impact Scale.Results: A total of 48 participants completed the intervention period. The HAL-group walked twice as far as the Conventional group during the intervention. Post-intervention, both groups exhibited improved 6 MWT results, while the Control group had declined. A significant improvement was only found in the Conventional group and when compared to the Control group (Tukey HSD p = 0.022), and not between the HAL group and Conventional group (Tukey HSD p = 0.258) or the HAL- group and the Control group (Tukey HSD p = 0.447). There was also a significant decline in the Conventional group from post-intervention to 6 months follow up (p = 0.043). The best fitting model to predict outcome included initial balance (BBS), followed by stroke severity (NIHSS), and dependence in activity and participation (BI and MRS).Conclusion: Intensive conventional gait training induced significant improvements long-term after stroke while integrating treadmill based EAGT had no additional value in this study sample. The results may support cost effective evidence-based interventions for gait training long-term after stroke and further development of EAGT.Trial registration: Published on clinicaltrials.gov (NCT02545088) August 24, 2015.

scholarly journals Pulmonary rehabilitation to improve physical capacity, dyspnea and quality of life following pulmonary embolism (the PeRehab study): Study protocol for a two-centre randomized controlled trial.

2020 ◽  
Author(s):  
Stacey Haukeland-Parker ◽  
Øyvind Jervan ◽  
Hege Hølmo Johannessen ◽  
Jostein Gleditsch ◽  
Knut Stavem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Physical Capacity ◽  
Control Group ◽  
Walk Test ◽  
Randomized Controlled

Abstract Background: Recently, a large group of patients with persistent dyspnea, poor physical capacity and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name “post pulmonary embolism syndrome” (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea and HRQoL in PPS patients.Methods: A two-centre randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 hour) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise. Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the Modified Medical Research Council scale, the Shortness of Breath questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL).Recruitment of 190 patients is currently ongoing.Discussion: Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity and better HRQoL following PE.Trial registration: NCT03405480, Clinical Trials (registered prospectively.Protocol version 1 (from original protocol September 2017).The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial

2015 ◽  
Vol 22 (3) ◽  
pp. 373-384 ◽  
Author(s):  
Sofia Straudi ◽  
Chiara Fanciullacci ◽  
Carlotta Martinuzzi ◽  
Claudia Pavarelli ◽  
Bruno Rossi ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Short Form ◽  
Gait Training ◽  
Progressive Multiple Sclerosis ◽  
Controlled Study ◽  
Walking Ability ◽  
Walk Test ◽  
Robot Assisted ◽  
Positive Effects ◽  
Randomized Controlled

Background: Gait and mobility impairments are common in progressive multiple sclerosis (MS), leading to reduced quality of life (QoL). Objective: In this randomized controlled study, we tested the effects of robot-assisted gait training (RAGT) and compared it to conventional physiotherapy, measuring walking ability, depression, fatigue, and QoL in patients with progressive MS and severe gait disability. Methods: Fifty-two participants (Expanded Disability Status Scale score 6–7) completed the study protocol. They received two sessions/week over 6 weeks of RAGT or conventional walking therapy. Outcome measures were Six-Minute Walk Test, Ten-Meter Walk Test, Timed Up and Go Test, Berg Balance Scale, Fatigue Severity Scale, Patient Health Questionnaire, and Short Form 36. They were performed pre-treatment, post-treatment, and at 3 months. Results: Walking endurance ( p < 0.01) and balance ( p < 0.01) were improved among those in the RAGT group. Positive effects on depression in both treatment groups were highlighted. However, only among those in the RAGT group was perceived physical functioning QoL increased. No significant effects on fatigue were found. Conclusion: RAGT is a treatment option in progressive MS patients with severe gait impairments to induce short-lasting effects on mobility and QoL.

scholarly journals Changes in Balance, Gait and Electroencephalography Oscillations after Robot-Assisted Gait Training: An Exploratory Study in People with Chronic Stroke

2020 ◽  
Vol 10 (11) ◽  
pp. 821
Author(s):  
Hoon-Ming Heng ◽  
Ming-Kuei Lu ◽  
Li-Wei Chou ◽  
Nai-Hsin Meng ◽  
Hui-Chun Huang ◽  
...  
Keyword(s):  
Analysis Data ◽  
Gait Training ◽  
Berg Balance Scale ◽  
Chronic Stroke ◽  
Cycle Duration ◽  
Robot Assisted ◽  
Gait Parameters ◽  
Before And After ◽  
High Beta

Robot-assisted gait training (RAGT) systems offer the advantages of standard rehabilitation and provide precise and quantifiable control of therapy. We examined the clinical outcome of RAGT and analyzed the correlations between gait analysis data and event-related desynchronization (ERD) and event-related synchronization (ERS) in patients with chronic stroke. We applied the Berg balance scale (BBS) and analyzed gait parameters and the ERD and ERS of self-paced voluntary leg movements performed by patients with chronic stroke before and after undergoing RAGT. A significant change was observed in BBS (p = 0.011). We also showed preliminary outcomes of changes in gait cycle duration (p = 0.015) and in ipsilesional ERS in the low-beta (p = 0.033) and high-beta (p = 0.034) frequency bands before and after RAGT. In addition, correlations were observed between BBS and ipsilesional ERS in the alpha and low-beta bands (r = −0.52, p = 0.039; r = −0.52, p = 0.040). The study demonstrated that RAGT can improve balance and provided an idea of the possible role of brain oscillation and clinical outcomes in affecting stroke rehabilitation.

scholarly journals Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diplegic Cerebral Palsy: Randomized Controlled Trial

10.2196/18232 ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. e18232
Author(s):  
Hanaa Mohsen ◽  
Omnya Samy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Motor Function ◽  
Gait Training ◽  
Therapeutic Modality ◽  
Control Group ◽  
Study Group ◽  
Sensory Stimuli ◽  
Gait Parameters ◽  
Before And After

Background Limited attention has been given to the effectiveness of the platform swing walkway, which is a common way to improve gait pattern through activation of sensory stimuli (visual, auditory, vestibular, and somatosensory). Objective The objective of this study was to determine the effect of a platform swing walkway on gait parameters in children with diplegic cerebral palsy (CP). Methods A total of 30 children of both sexes (aged 6-8 years) with diplegic CP were enrolled in this study. They were randomly assigned into two groups of equal number: the control group (n=15) and the study group (n=15). The control group received the conventional physical therapy plan, whereas the study group received the same conventional physical therapy program in addition to gait training on a platform swing walkway. Temporal parameters during the gait cycle were collected using gait tracker video analysis, and the Growth Motor Function Measure Scale (GMFM-88) was used to assess standing and walking (Dimensions D and E) before and after the treatment program. Results A statistically significant improvement in both groups was noted when comparing the mean values of all measured variables before and after treatment (P≤.05). There were significant differences between the control and study groups with respect to all measured variables, which favored the study group when comparing the posttreatment outcomes (P≤.05). Conclusions Results suggest that gait training on platform swing walkways can be included as an alternative therapeutic modality to enhance gait parameters and gross motor function in children with diplegic CP. Trial Registration ClinicalTrials.gov NTC04246658; https://clinicaltrials.gov/ct2/show/NTC04246658

scholarly journals Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diplegic Cerebral Palsy: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Hanaa Mohsen ◽  
Omnya Samy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Motor Function ◽  
Gait Training ◽  
Therapeutic Modality ◽  
Control Group ◽  
Study Group ◽  
Sensory Stimuli ◽  
Gait Parameters ◽  
Before And After

BACKGROUND Limited attention has been given to the effectiveness of the platform swing walkway, which is a common way to improve gait pattern through activation of sensory stimuli (visual, auditory, vestibular, and somatosensory). OBJECTIVE The objective of this study was to determine the effect of a platform swing walkway on gait parameters in children with diplegic cerebral palsy (CP). METHODS A total of 30 children of both sexes (aged 6-8 years) with diplegic CP were enrolled in this study. They were randomly assigned into two groups of equal number: the control group (n=15) and the study group (n=15). The control group received the conventional physical therapy plan, whereas the study group received the same conventional physical therapy program in addition to gait training on a platform swing walkway. Temporal parameters during the gait cycle were collected using gait tracker video analysis, and the Growth Motor Function Measure Scale (GMFM-88) was used to assess standing and walking (Dimensions D and E) before and after the treatment program. RESULTS A statistically significant improvement in both groups was noted when comparing the mean values of all measured variables before and after treatment (<i>P</i>≤.05). There were significant differences between the control and study groups with respect to all measured variables, which favored the study group when comparing the posttreatment outcomes (<i>P</i>≤.05). CONCLUSIONS Results suggest that gait training on platform swing walkways can be included as an alternative therapeutic modality to enhance gait parameters and gross motor function in children with diplegic CP. CLINICALTRIAL ClinicalTrials.gov NTC04246658; https://clinicaltrials.gov/ct2/show/NTC04246658

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

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