Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. Can we improve gait skills in chronic hemiplegics? A randomised control trial with gait trainer. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Treadmill training with partial body weight support and an electromechanical gait trainer for restoration of gait in subacute stroke patients: a randomized crossover study. Effects of locomotion training with assistance of a robot-driven gait orthosis in hemiparetic patients after stroke: a randomized controlled pilot study. The effectiveness of body weight-supported gait training and floor walking in patients with chronic stroke. Effects of intensive therapy using gait trainer or floor walking exercises early after stroke. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Effectiveness of gait training using an electromechanical gait trainer, with and without functional electric stimulation, in subacute stroke: a randomized controlled trial. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke.
To evaluate the effect of repetitive locomotor training on an electromechanical gait trainer plus physiotherapy in subacute stroke patients.
                Randomized controlled trial.
                Four German neurological rehabilitation centres.
                One hundred and fifty-five non-ambulatory patients (first-time stroke <60 days).
                Group A received 20 min locomotor training and 25 min physiotherapy; group B had 45 min physiotherapy every week day for four weeks.
                Primary variables were gait ability (Functional Ambulation Category, 0-5) and the Barthel Index (0-100), blindly assessed at study onset, end, and six months later for follow-up. Responders to the therapy had to become ambulatory (Functional Ambulation Category 4 or 5) or reach a Barthel Index of > or = 75. Secondary variables were walking velocity, endurance, mobility and leg power.
                The intention-to-treat analysis revealed that significantly greater number of patients in group A could walk independently: 41 of 77 versus 17 of 78 in group B (P B < 0.0001) at treatment end. Also, significantly more group A patients had reached a Barthel Index > or = 75: 44 of 77 versus 21 of 78 (P B < 0.0001). At six-month follow-up, the superior gait ability in group A persisted (54 of 77 versus 28 of 78, P B < 0.0001), while the Barthel Index responder rate did not differ. For all secondary variables, group A patients had improved significantly more (P B < 0.0001) during the treatment period, but not during follow-up.
                Intensive locomotor training plus physiotherapy resulted in a significantly better gait ability and daily living competence in subacute stroke patients compared with physiotherapy alone. To evaluate the effectiveness of early and prolonged locomotor treatment with the use of a robotic-assisted gait training (RAGT) device (Lokomat; Hocoma Inc., Zurich, Switzerland) on the functional outcomes of patients after subacute stroke.
                A nonblinded prospective, randomized, controlled study.
                Rehabilitation department in tertiary university medical center.
                Sixty-seven patients in the first 3 months after subacute stroke were randomized into 2 groups as follows. Thirty-seven patients were treated with RAGT, and 30 were treated with regular physiotherapy. Inclusion criteria were first stroke, independent ambulation before the stroke, and neurological severity between 6 and 20 according to the National Institutes of Health Stroke Scale (NIHSS).
                RAGT treatment was administered 3 times a week for 30 minutes, combined with regular physiotherapy for 6 weeks. Control patients received the equivalent additional time of regular physiotherapy.
                The primary outcome was the ability to walk independently, as assessed by use of the functional ambulatory capacity scale. The secondary outcomes included the neurological status according to the NIHSS; functional motor assessment (determined by use of the stroke activity scale); and gait parameters, including gait velocity, endurance, and number of climbed stairs.
                In the intention-to-treat analysis, subjects in the RAGT group exhibited greater gains than the control group in their ability to walk independently, as expressed by a greater functional ambulatory capacity score (P < .01), and in their neurological status according to NIHSS (P < .01). Among those who achieved independent walking, nonsignificant differences between groups were noted according to secondary outcome measures of gait parameters except from step climbing.
                This controlled study showed, at the end of a 6-week trial, that locomotor therapy with the use of RAGT combined with regular physiotherapy produced promising effects on functional and motor outcomes in patients after subacute stroke as compared with regular physiotherapy alone. Partial body weight support (PBWS) is an accepted treatment for hemiplegic patients. The aim of this study is to compare the efficiency of gait trainer with conventional treatment on the gait management after stroke.
                Forty chronic post-stroke hemiplegics were part of a prospective research. Inclusion criteria were: first ever stroke in a chronic stage with stabilised motor deficits; age >18 and <80 years; cognitive and communication skills to understand the treatment; absence of cardiac, psychological and orthopedic contraindications. Patients were randomised into two groups: the control group (CG) that used the Bobath method in 40 minutes sessions, 5 times a week, for 5 weeks, and the experimental group (EG) that used the gait trainer, for the same period of time and frequency. Assessment tools: Motricity Index (MI); Toulouse Motor Scale (TMS); modified Ashworth Spasticity Scale (mASS); Berg Balance Scale (BBS); Rivermead Mobility Index (RMI); Fugl-Meyer Stroke Scale (F-MSS); Functional Ambulation Category (FAC); Barthel Index (BI); 10 meters, time up and go (TUG), 6 minutes, and step tests. EG and CG did the assessments before treatment (T(0)), right after treatment (T(1)), and on follow-up, 3 months later (T(2)).
                CG and EG were homogenous in all the variables at T(0). CG and EG showed improvement in almost all the assessment scales after treatment, although only some with relevant differences. EG showed statistically relevant improvement on T(1) and on T(2) in several of the assessment tools, whereas CG only showed statistically significant improvement after T(1) and only in some of the assessment tools.
                Both groups of chronic hemiplegic patients improved after either PBWS with gait trainer or Bobath treatment. Only subjects undergoing PBWS with gait trainer maintained functional gain after 3 months. To compare the efficacy of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke.
                A total of 63 participants<6 months poststroke with an initial walking speed between 0.1 to 0.6 m/s completed the multicenter, randomized clinical trial. All participants received twenty-four 1-hour sessions of either Lokomat or conventional gait training. Outcome measures were evaluated prior to training, after 12 and 24 sessions, and at a 3-month follow-up exam. Self-selected overground walking speed and distance walked in 6 minutes were the primary outcome measures, whereas secondary outcome measures included balance, mobility and function, cadence and symmetry, level of disability, and quality of life measures.
                Participants who received conventional gait training experienced significantly greater gains in walking speed (P=.002) and distance (P=.03) than those trained on the Lokomat. These differences were maintained at the 3-month follow-up evaluation. Secondary measures were not different between the 2 groups, although a 2-fold greater improvement in cadence was observed in the conventional versus Lokomat group.
                For subacute stroke participants with moderate to severe gait impairments, the diversity of conventional gait training interventions appears to be more effective than robotic-assisted gait training for facilitating returns in walking ability. The purpose of this study was to compare treadmill and electromechanical gait trainer therapy in subacute, nonambulatory stroke survivors. The gait trainer was designed to provide nonambulatory subjects the repetitive practice of a gait-like movement without overexerting therapists.
                This was a randomized, controlled study with a crossover design following an A-B-A versus a B-A-B pattern. A consisted of 2 weeks of gait trainer therapy, and B consisted of 2 weeks of treadmill therapy. Thirty nonambulatory hemiparetic patients, 4 to 12 weeks after stroke, were randomly assigned to 1 of the 2 groups receiving locomotor therapy every workday for 15 to 20 minutes for 6 weeks. Weekly gait ability (functional ambulation category [FAC]), gait velocity, and the required physical assistance during both kinds of locomotor therapy were the primary outcome measures, and other motor functions (Rivermead motor assessment score) and ankle spasticity (modified Ashworth score) were the secondary outcome measures. Follow-up occurred 6 months later.
                The groups did not differ at study onset with respect to the clinical characteristics and effector variables. During treatment, the FAC, gait velocity, and Rivermead scores improved in both groups, and ankle spasticity did not change. Median FAC level was 4 (3 to 4) in group A compared with 3 (2 to 3) in group B at the end of treatment (P=0.018), but the difference at 6-month follow up was not significant. The therapeutic effort was less on the gait trainer, with 1 instead of 2 therapists assisting the patient at study onset. All but seven patients preferred the gait trainer.
                The newly developed gait trainer was at least as effective as treadmill therapy with partial body weight support while requiring less input from the therapist. Further studies are warranted. The success of gait rehabilitation after stroke depends on active walking exercises. However, the disabling after-effects of stroke often make such exercises impossible at the onset of therapy. To facilitate treadmill training of paraparetic patients, a robot-driven gait orthosis (Lokomat) was developed. We investigated the effects of the Lokomat when used with hemiparetic patients.
                The authors conducted a randomized, controlled pilot study of 30 acute stroke survivors. The treatment group received 30 minutes of robotic training daily and the control group 30 minutes of conventional physiotherapy daily in addition to 30 minutes of conventional physiotherapy for each group. Outcome measures were independence of gait, gait speed, gait parameters, and body tissue composition.
                After 4 weeks of therapy, the walking ability of the Lokomat group and the control group expressed as the functional ambulation classification was significantly improved. The functional ambulation category (median+/- interquartile range) was at baseline 0+/-0 in control and 0+/-1 in the therapy group and increased after therapy to 1+/-3 in both groups significantly (P=0.01). There was no significant difference in gain of these parameters between the groups. The Lokomat group had a significantly longer single stance phase (sec; mean+/-SEM) on the paretic leg when walking on the floor. At baseline, it was 0.19+/-0.17 and after therapy 0.49+/-0.07 (P=0.014). The control group had increased their body weight approximately 1.33+/-1.40 kg (mean+/-SEM; P=0.046), mostly as fat mass, whereas the Lokomat group had lost fat mass approximately -2.9+/-1.0 kg (mean+/-SEM; P=0.016) and increased their muscle mass approximately 3.36+/-1.4 kg (mean+/- SEM; P=0.031).
                This pilot study indicates that Lokomat therapy is a promising intervention for gait rehabilitation. Although there was no difference between groups in gain of functional scores, the Lokomat group showed an advantage of robotic training over conventional physiotherapy in improvement of gait abnormality and body tissue composition. To compare body weight-supported exercise on a gait trainer with walking exercise overground.
                Randomized controlled trial.
                Rehabilitation hospital.
                Forty-five ambulatory patients with chronic stroke.
                Patients were randomized to 3 groups: (1) gait trainer exercise with functional electric stimulation (GTstim), (2) gait trainer exercise without stimulation (GT), and (3) walking overground (WALK). All patients practiced gait for 15 sessions during 3 weeks (each session, 20 min), and they received additional physiotherapy 55 minutes daily.
                Ten-meter walk test (10MWT), six-minute walk test (6MWT), lower-limb spasticity and muscle force, postural sway tests, Modified Motor Assessment Scale (MMAS), and FIM instrument scores were recorded before, during, and after the rehabilitation and at 6 months follow-up.
                The mean walking distance using the gait trainer was 6900+/-1200 m in the GTstim group and 6500+/-1700 m in GT group. In the WALK group, the distance was 4800+/-2800 m, which was less than the walking distance obtained in the GTstim group (P=.027). The body-weight support was individually reduced from 30% to 9% of the body weight over the course of the program. In the pooled 45 patients, the 10MWT (P<.001), 6MWT (P<.001), MMAS (P<.001), dynamic balance test time (P<.001), and test trip (P=.005) scores improved; however, no differences were found between the groups.
                Both the body weight-supported training and walking exercise training programs resulted in faster gait after the intensive rehabilitation program. Patients' motor performance remained improved at the follow-up. To analyse the effects of gait therapy for patients after acute stroke in a randomized controlled trial.
                Fifty-six patients with a mean of 8 days post-stroke participated in: (i) gait trainer exercise; (ii) walking training over ground; or (iii) conventional treatment. Patients in the gait trainer exercise and walking groups practiced gait for 15 sessions over 3 weeks and received additional physiotherapy. Functional Ambulatory Category and several secondary outcome measures assessing gait and mobility were administered before and after rehabilitation and at 6-month follow-up. Patients also evaluated their own effort.
                Walking ability improved more with intensive walk training compared with conventional treatment; median Functional Ambulatory Category was zero in all patients at the start of the study, but it was 3 in both walk-training groups and 0.5 in the conventional treatment group at the end of the therapy. Median Functional Ambulatory Category was 4 in both walk-training groups and 2.5 in conventional treatment group at 6-month follow-up. Mean accomplished walking distance was not different between the gait trainer exercise and over ground walking groups. Borg scale indicated more effort in over ground walking. Secondary outcomes also indicated improvements.
                Exercise therapy with walking training improved gait function irrespective of the method used, but the time and effort required to achieve the results favour the gait trainer exercise. Early intensive gait training resulted in better walking ability than did conventional treatment. Locomotor training (LT) using a treadmill can improve walking ability over conventional rehabilitation in individuals with hemiparesis, although the personnel requirements often necessary to provide LT may limit its application. Robotic devices that provide consistent symmetrical assistance have been developed to facilitate LT, although their effectiveness in improving locomotor ability has not been well established.
                Forty-eight ambulatory chronic stroke survivors stratified by severity of locomotor deficits completed a randomized controlled study on the effects of robotic- versus therapist-assisted LT. Both groups received 12 LT sessions for 30 minutes at similar speeds, with guided symmetrical locomotor assistance using a robotic orthosis versus manual facilitation from a single therapist using an assist-as-needed paradigm. Outcome measures included gait speed and symmetry, and clinical measures of activity and participation.
                Greater improvements in speed and single limb stance time on the impaired leg were observed in subjects who received therapist-assisted LT, with larger speed improvements in those with less severe gait deficits. Perceived rating of the effects of physical limitations on quality of life improved only in subjects with severe gait deficits who received therapist-assisted LT.
                Therapist-assisted LT facilitates greater improvements in walking ability in ambulatory stroke survivors as compared to a similar dosage of robotic-assisted LT. To compare the therapeutic effects of conventional gait training (CGT), gait training using an electromechanical gait trainer (EGT), and gait training using an electromechanical gait trainer with functional electric stimulation (EGT-FES) in people with subacute stroke.
                Nonblinded randomized controlled trial.
                Rehabilitation hospital for adults.
                Fifty patients were recruited within 6 weeks after stroke onset; 46 of these completed the 4-week training period.
                Participants were randomly assigned to 1 of 3 gait intervention groups: CGT, EGT, or EGT-FES. The experimental intervention was a 20-minute session per day, 5 days a week (weekdays) for 4 weeks. In addition, all participants received their 40-minute sessions of regular physical therapy every weekday as part of their treatment by the hospital.
                Five-meter walking speed test, Elderly Mobility Scale (EMS), Berg Balance Scale, Functional Ambulatory Category (FAC), Motricity Index leg subscale, FIM instrument score, and Barthel Index.
                The EGT and EGT-FES groups had statistically significantly more improvement than the CGT group in the 5-m walking speed test (CGT vs EGT, P=.011; CGT vs EGT-FES, P=.001), Motricity Index (CGT vs EGT-FES, P=.011), EMS (CGT vs EGT, P=.006; CGT vs EGT-FES, P=.009), and FAC (CGT vs EGT, P=.005; CGT vs EGT-FES, P=.002) after the 4 weeks of training. No statistically significant differences were found between the EGT and EGT-FES groups in all outcome measures.
                In this sample with subacute stroke, participants who trained on the electromechanical gait trainer with body-weight support, with or without FES, had a faster gait, better mobility, and improvement in functional ambulation than participants who underwent conventional gait training. Future studies with assessor blinding and larger sample sizes are warranted. While manually-assisted body-weight supported treadmill training (BWSTT) has revealed improved locomotor function in persons with post-stroke hemiparesis, outcomes are inconsistent and it is very labor intensive. Thus an alternate treatment approach is desirable. Objectives of this pilot study were to: 1) compare the efficacy of body-weight supported treadmill training (BWSTT) combined with the Lokomat robotic gait orthosis versus manually-assisted BWSTT for locomotor training post-stroke, and 2) assess effects of fast versus slow treadmill training speed.
                Sixteen volunteers with chronic hemiparetic gait (0.62 +/- 0.30 m/s) post-stroke were randomly allocated to Lokomat (n = 8) or manual-BWSTT (n = 8) 3x/wk for 4 weeks. Groups were also stratified by fast (mean 0.92 +/- 0.15 m/s) or slow (0.58 +/- 0.12 m/s) training speeds. The primary outcomes were self-selected overground walking speed and paretic step length ratio. Secondary outcomes included: fast overground walking speed, 6-minute walk test, and a battery of clinical measures.
                No significant differences in primary outcomes were revealed between Lokomat and manual groups as a result of training. However, within the Lokomat group, self-selected walk speed, paretic step length ratio, and four of the six secondary measures improved (p = 0.04-0.05, effect sizes = 0.19-0.60). Within the manual group, only balance scores improved (p = 0.02, effect size = 0.57). Group differences between fast and slow training groups were not revealed (p > or = 0.28).
                Results suggest that Lokomat training may have advantages over manual-BWSTT following a modest intervention dose in chronic hemiparetic persons and further, that our training speeds produce similar gait improvements. Suggestions for a larger randomized controlled trial with optimal study parameters are provided.
Patients who receive electromechanical-assisted gait training in combination with physiotherapy after stroke are more likely to achieve independent walking than patients receiving gait training without these devices. However, further research should address specific questions, for example what frequency or duration of electromechanical-assisted gait training might be most effective and at what time after stroke. Follow-up studies are also needed to find out how long the benefit lasts.