Dataset Information

Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Robot-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.

Methods

This 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.

Discussion

This 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 registration

ClinicalTrials.gov, NCT03490578 . Registered on 21 March 2018.

SUBMITTER: Kang MG

PROVIDER: S-EPMC6322303 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.

Kang Min-Gu MG Yun Seo Jung SJ Shin Hyun Iee HI Kim Eunkyung E Lee Hyun Haeng HH Oh Byung-Mo BM Seo Han Gil HG

Trials 20190107 1

<h4>Background</h4>Robot-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 th ...[more]

PMID: 30616685

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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:This study investigated the effects of robot-assisted gait training (RAGT) on gait function in burn patients. Briefly, 40 burn patients were randomly divided into an RAGT group or a conventional training (CON) group. SUBAR® (Cretem, Korea) is a wearable robot with a footplate that simulates normal gait cycles. The RAGT group underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy once a day, 5 days a week for 12 weeks. Patients in the CON group received 30 min of overground gait training and range-of-motion (ROM) exercises twice a day for 5 days a week for 12 weeks. The RAGT group and the CON group underwent 60 min of training per day. The intervention frequency and duration did not differ between the RAGT group and the CON group. The main outcomes were functional ambulatory category (FAC); 6-min walking test (6MWT); visual analogue scale (VAS) during gait movement; ROM; and isometric forces of bilateral hip, knee, and ankle muscles before and after 12 weeks of training. The results of the VAS, FAC, and 6MWT (8.06 ± 0.66, 1.76 ± 0.56, and 204.41 ± 85.60) before training in the RAGT group improved significantly (4.41 ± 1.18, 4.18 ± 0.39, and 298.53 ± 47.75) after training (p < 0.001, p < 0.001, and p < 0.001). The results of the VAS, FAC, and 6MWT (8.00 ± 1.21, 1.75 ± 0.58, and 220.94 ± 116.88) before training in the CON group improved significantly (5.00 ± 1.03, 3.81 ± 1.05, and 272.19 ± 110.14) after training (p < 0.001, p < 0.001, and p = 0.05). There were differences in the improvement of results of the VAS, FAC, and 6MWT between groups after training, but they were not statistically significant (p = 0.23, p = 0.14, and p = 0.05). The isometric strengths of the right hip extensor (p = 0.02), bilateral knee flexor (p = 0.04 in the right, and p = 0.001 in the left), bilateral knee extensor (p = 0.003 in the right, and p = 0.002 in the left), bilateral ankle dorsiflexor (p = 0.04 in the right, and p = 0.02 in the left), and bilateral ankle plantarflexor (p = 0.001 in the right, and p = 0.008 in the left) after training were significantly improved compared with those before training in the RAGT group. The ROMs of the right knee extension (p = 0.03) and bilateral ankle plantarflexion (p = 0.008 in the right, and p = 0.03 in the left) were significantly improved compared with measurements before training in the RAGT. There were no significant differences of the isometric strengths and ROMs of the bilateral hip, knee, and ankle muscles after training in the CON group. There were significant improvements in the isometric strengths of the left knee flexor (p = 0.01), left ankle dorsiflexor (p = 0.01), and left ankle plantarflexor (p = 0.003) between the two groups. The results suggested that RAGT is effective to facilitate early recovery of muscles strength after a burn injury. This is the first study to evaluate the effectiveness of RAGT in patients with burns compared with those receiving conventional training. The absence of complications in burn patients provides an opportunity to enlarge the application area of RAGT.

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:Balance impairments are common in patients with infratentorial stroke. Although robot-assisted gait training (RAGT) exerts positive effects on balance among patients with stroke, it remains unclear whether such training is superior to conventional physical therapy (CPT). Therefore, we aimed to investigate the effects of RAGT combined with CPT and compared them with the effects of CPT only on balance and lower extremity function among survivors of infratentorial stroke. METHODS:This study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation hospital. Patients (n?=?19; 16 men, three women; mean age: 47.4?±?11.6?years) with infratentorial stroke were randomly allocated to either group A (4?weeks of RAGT+CPT, followed by 4?weeks of CPT+CPT) or group B (4?weeks of CPT+CPT followed by 4?weeks of RAGT+CPT). Changes in dynamic and static balance as indicated by Berg Balance Scale scores were regarded as the primary outcome measure. Outcome measures were evaluated for each participant at baseline and after each 4-week intervention period. RESULTS:No significant differences in outcome-related variables were observed between group A and B at baseline. In addition, no significant time-by-group interactions were observed for any variables, indicating that intervention order had no effect on lower extremity function or balance. Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention. CONCLUSION:RAGT produces clinically significant improvements in balance and lower extremity function in individuals with infratentorial stroke. Thus, RAGT may be useful for patients with balance impairments secondary to other pathologies. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT02680691. Registered 09 February 2016; retrospectively registered.

Project description:BackgroundGait 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.MethodsThis 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).DiscussionThe 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.Trial registrationClinicalTrials.gov, identifier: NCT02421731 . Registered on 19 January 2015 (retrospectively registered).

Project description:BackgroundWalking ability is a priority for many children with cerebral palsy (CP) and their parents when considering domains of importance regarding treatment interventions. Partial body-weight supported treadmill training has become an established therapeutic treatment approach to address this demand. Further, new robotic rehabilitation technologies have increasingly been implemented in the clinical setting to allow for longer training sessions with increased step repetitions while maintaining a consistent movement pattern. But the current evidence about its clinical effectiveness in pediatric rehabilitation is weak. The aim of this research project is therefore to investigate the effectiveness of robot-assisted gait training on improvements of functional gait parameters in children with cerebral palsy.Methods/designChildren aged 6 to 18 years with bilateral spastic cerebral palsy who are able to walk at least 14 m with or without walking aids will be recruited in two pediatric therapy centers in Switzerland. Within a pragmatic cross-over design with randomized treatment sequences, they perform 5 weeks of robot-assisted gait training (three times per week with a maximum of 45 min walking time each) or a 5-week period of standard treatment, which is individually customized to the needs of the child and usually consists of 1-2 sessions of physiotherapy per week and additional hippotherapy, circuit training as well as occupational therapy as necessary. Both interventions take place in an outpatient setting. The percentage score of the dimension E of the Gross Motor Function Measure-88 (GMFM-88) as primary outcome as well as the dimension D of the GMFM-88, 6-minute and 10-meter walking tests as secondary outcomes are assessed before and at the end of each intervention period. Additionally, a 5-week follow-up assessment is scheduled for the children who are assigned to the standard treatment first. Treatment effects, period effects as well as follow-up effects are analyzed with paired analyses and independent test statistics are used to assess carry-over effects.DiscussionAlthough robot-assisted gait training has become an established treatment option to address gait impairments, evidence for its effectiveness is vague. This pragmatic trial will provide important information on its effects under clinical outpatient conditions.Trial registrationClinicalTrials.gov: NCT00887848 . Registered 23 April 2009.

Dataset Information

Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.

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