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Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

ABSTRACT: After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke.This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (?20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained.Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events.This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

SUBMITTER: Stoller O

PROVIDER: S-EPMC3849994 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

Stoller Oliver O de Bruin Eling D ED Schuster-Amft Corina C Schindelholz Matthias M de Bie Rob A RA Hunt Kenneth J KJ

Trials 20130922

<h4>Background</h4>After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in se ...[more]

PMID: 24053609

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Project description:Cardiovascular fitness is greatly reduced after stroke. Although individuals with mild to moderate impairments benefit from conventional cardiovascular exercise interventions, there is a lack of effective approaches for persons with severely impaired physical function. This randomized controlled pilot trial investigated efficacy and feasibility of feedback-controlled robotics-assisted treadmill exercise (FC-RATE) for cardiovascular rehabilitation in persons with severe impairments early after stroke.Twenty individuals (age 61 ± 11 years; 52 ± 31 days poststroke) with severe motor limitations (Functional Ambulation Classification 0-2) were recruited for FC-RATE or conventional robotics-assisted treadmill exercise (RATE) (4 weeks, 3 × 30-minute sessions/wk). Outcome measures focused on peak cardiopulmonary performance parameters, training intensity, and feasibility, with examiners blinded to allocation.All 14 allocated participants (70% of recruited) completed the intervention (7/group, withdrawals unrelated to intervention), without serious adverse events occurring. Cardiovascular fitness increased significantly in both groups, with peak oxygen uptake increasing from 14.6 to 17.7 mL · kg · min (+17.8%) after 4 weeks (45.8%-55.7% of predicted maximal aerobic capacity; time effect P = 0.01; no group-time interaction). Training intensity (% heart rate reserve) was significantly higher for FC-RATE (40% ± 3%) than for conventional RATE (14% ± 2%) (P = 0.001).Substantive overall increases in the main cardiopulmonary performance parameters were observed, but there were no significant between-group differences when comparing FC-RATE and conventional RATE. Feedback-controlled robotics-assisted treadmill exercise significantly increased exercise intensity, but recommended intensity levels for cardiovascular training were not consistently achieved. Future research should focus on appropriate algorithms within advanced robotic systems to promote optimal cardiovascular stress.Video abstract available for more insights from the authors (Supplemental Digital Content 1, http://links.lww.com/JNPT/A107).

Project description:BackgroundExercise capacity is seriously reduced after stroke. While cardiopulmonary assessment and intervention strategies have been validated for the mildly and moderately impaired populations post-stroke, there is a lack of effective concepts for stroke survivors suffering from severe motor limitations. This study investigated the test-retest reliability and repeatability of cardiopulmonary exercise testing (CPET) using feedback-controlled robotics-assisted treadmill exercise (FC-RATE) in severely motor impaired individuals early after stroke.Methods20 subjects (age 44-84 years, <6 month post-stroke) with severe motor limitations (Functional Ambulatory Classification 0-2) were selected for consecutive constant load testing (CLT) and incremental exercise testing (IET) within a powered exoskeleton, synchronised with a treadmill and a body weight support system. A manual human-in-the-loop feedback system was used to guide individual work rate levels. Outcome variables focussed on standard cardiopulmonary performance parameters. Relative and absolute test-retest reliability were assessed by intraclass correlation coefficients (ICC), standard error of the measurement (SEM), and minimal detectable change (MDC). Mean difference, limits of agreement, and coefficient of variation (CoV) were estimated to assess repeatability.ResultsPeak performance parameters during IET yielded good to excellent relative reliability: absolute peak oxygen uptake (ICC?=0.82), relative peak oxygen uptake (ICC?=0.72), peak work rate (ICC?=0.91), peak heart rate (ICC?=0.80), absolute gas exchange threshold (ICC?=0.91), relative gas exchange threshold (ICC?=0.88), oxygen cost of work (ICC?=0.87), oxygen pulse at peak oxygen uptake (ICC?=0.92), ventilation rate versus carbon dioxide output slope (ICC?=0.78). For these variables, SEM was 4-13%, MDC 12-36%, and CoV 0.10-0.36. CLT revealed high mean differences and insufficient test-retest reliability for all variables studied.ConclusionsThis study presents first evidence on reliability and repeatability for CPET in severely motor impaired individuals early after stroke using a feedback-controlled robotics-assisted treadmill. The results demonstrate good to excellent test-retest reliability and appropriate repeatability for the most important peak cardiopulmonary performance parameters. These findings have important implications for the design and implementation of cardiovascular exercise interventions in severely impaired populations. Future research needs to develop advanced control strategies to enable the true limit of functional exercise capacity to be reached and to further assess test-retest reliability and repeatability in larger samples.

Project description:Purpose: Robot-assisted training has been widely used in neurorehabilitation, but its effect on facilitating recovery after stroke remains controversial. One possible reason might be lacking consideration of the role of embodiment in robotic systems. Mirror visual feedback is an ideal method to approach embodiment. Thus, we hypothesized that mirror visual feedback priming with subsequent robot-assisted training might provide additional treatment benefits in rehabilitation. Method: This is a prospective, assessor-blinded, randomized, controlled study. Forty subacute stroke patients were randomly assigned into an experimental group (N = 20) or a control group (N = 20). They received either mirror visual feedback or sham-mirror visual feedback prior to robot-assisted training for 1.5 h/day, 5 days/week for 4 weeks. Before and after intervention, the Fugl-Meyer Assessment Upper Limb subscale, the Functional Independence Measure, the modified Barthel Index, and grip strength were measured. Scores of four specified games were recorded pre and post one-time mirror visual feedback priming before intervention in the experimental group. Results: All measurements improved significantly in both groups following interventions. Moreover, the Fugl-Meyer Assessment Upper Limb subscale, self-care subscale of the Functional Independence Measure, and the grip strength were improved significantly in the experimental group after a 4-week intervention, compared with the control group. Significantly higher scores of two games were revealed after one-time priming. Conclusions: Mirror visual feedback prior to robot-assisted training could prompt motor recovery, increase ability of self-care, and potentially enhance grip strength in stroke patients, compared to control treatment. Moreover, mirror visual feedback priming might have the capability to improve the patient's performance and engagement during robot-assisted training, which could prompt the design and development of robotic systems. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: ChiCTR1900023356.

Project description:BackgroundLocomotor training, including the use of body-weight support in treadmill stepping, is a physical therapy intervention used to improve recovery of the ability to walk after stroke. The effectiveness and appropriate timing of this intervention have not been established.MethodsWe stratified 408 participants who had had a stroke 2 months earlier according to the extent of walking impairment--moderate (able to walk 0.4 to <0.8 m per second) or severe (able to walk <0.4 m per second)--and randomly assigned them to one of three training groups. One group received training on a treadmill with the use of body-weight support 2 months after the stroke had occurred (early locomotor training), the second group received this training 6 months after the stroke had occurred (late locomotor training), and the third group participated in an exercise program at home managed by a physical therapist 2 months after the stroke (home-exercise program). Each intervention included 36 sessions of 90 minutes each for 12 to 16 weeks. The primary outcome was the proportion of participants in each group who had an improvement in functional walking ability 1 year after the stroke.ResultsAt 1 year, 52.0% of all participants had increased functional walking ability. No significant differences in improvement were found between early locomotor training and home exercise (adjusted odds ratio for the primary outcome, 0.83; 95% confidence interval [CI], 0.50 to 1.39) or between late locomotor training and home exercise (adjusted odds ratio, 1.19; 95% CI, 0.72 to 1.99). All groups had similar improvements in walking speed, motor recovery, balance, functional status, and quality of life. Neither the delay in initiating the late locomotor training nor the severity of the initial impairment affected the outcome at 1 year. Ten related serious adverse events were reported (occurring in 2.2% of participants undergoing early locomotor training, 3.5% of those undergoing late locomotor training, and 1.6% of those engaging in home exercise). As compared with the home-exercise group, each of the groups receiving locomotor training had a higher frequency of dizziness or faintness during treatment (P=0.008). Among patients with severe walking impairment, multiple falls were more common in the group receiving early locomotor training than in the other two groups (P=0.02).ConclusionsLocomotor training, including the use of body-weight support in stepping on a treadmill, was not shown to be superior to progressive exercise at home managed by a physical therapist. (Funded by the National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research; LEAPS ClinicalTrials.gov number, NCT00243919.).

Project description:BackgroundStroke rehabilitation often uses the motor relearning concept that require patients to perform active practice of skill-specific training and to receive feedback. Treadmill training augmented with real-time visualisation feedback and functional electrical stimulation may have a beneficial synergistic effect on motor recovery. This study aims to determine the feasibility of this kind of enhanced treadmill training for gait rehabilitation among patients after stroke. A system for dynamic visualisation of lower-limb movement based on 3-dimentional motion capture and a computer timed functional electrical stimulation system was developed. Participants received up to 20-min enhanced treadmill training instead of their over-ground gait training once or twice a week for 6 weeks at Coathill hospital, Lanarkshire, United Kingdom. Number of training sessions attended, and training duration were used to assess feasibility. Ankle kinematics in the sagittal plane of walking with and without functional electrical stimulation support of the pre-tibial muscles were also compared and used to confirm the functional electrical stimulation was triggered at the targeted time.ResultsSix patients after stroke participated in the study. The majority of participants were male (5/6) with a age range from 30 to 84 years and 4/6 had left hemiplegia. All participants suffered from brain infarction and were at least 3 months after stroke. Number of training sessions attended ranged from 5 to 12. The duration of training sessions ranged from 11 to 20 min. No serious adverse events were reported. The computerised functional electrical stimulation to the pre-tibial muscles was able to reduce plantarflexion angle during the swing phase with statistical significance (p = 0.015 at 80%; p = 0.008 at 90 and 100% of the gait cycle).ConclusionsIt is safe and feasible to use treadmill gait training augmented with real-time visual feedback and computer-controlled functional electrical stimulation with patients after stroke in routine clinical practice.Trial registrationNCT03348215. Registered 20 November 2017.

Project description:Introduction: Robot-assisted therapy for upper extremity (UE) impairments post-stroke has yielded modest gains in motor capacity and little evidence of improved UE performance during activities of daily living. A paradigm shift that embodies principles of motor learning and exercise dependent neuroplasticity may improve robot therapy outcomes by incorporating active problem solving, salience of trained tasks, and strategies to facilitate the transfer of acquired motor skills to use of the paretic arm and hand during everyday activities. Objective: To pilot and test the feasibility of a novel therapy protocol, the Active Learning Program for Stroke (ALPS), designed to complement repetitive, robot-assisted therapy for the paretic UE. Key ALPS ingredients included training in the use of cognitive strategies (e.g., STOP, THINK, DO, CHECK) and a goal-directed home action plan (HAP) to facilitate UE self-management and skill transfer. Methods: Ten participants with moderate impairments in UE function >6 months after stroke received eighteen 1-h treatment sessions 2-3/x week over 6-8 weeks. In addition to ALPS training, individuals were randomly assigned to either robot-assisted therapy (RT) or robot therapy and task-oriented training (RT-TOT) to trial whether the inclusion of TOT reinforced participants' understanding and implementation of ALPS strategies. Results: Statistically significant group differences were found for the upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) at discharge and one-month follow-up favoring the RT group. Analyses to examine overall effects of the ALPS protocol in addition to RT and RT-TOT showed significant and moderate to large effects on the FMA-UE, Motor Activity Log, Wolf Motor Function Test, and hand portion of the Stroke Impact Scale. Conclusion: The ALPS protocol was the first to extend cognitive strategy training to robot-assisted therapy. The intervention in this development of concept pilot trial was feasible and well-tolerated, with good potential to optimize paretic UE performance following robot-assisted therapy.

Project description:Objective: It was the aim to assess feasibility, safety, and potential efficacy of a new intensive, focused arm-hand BOOST program and to investigate whether there is a difference between early vs. late delivery of the program in the sub-acute phase post stroke. Methods: In this pilot RCT, patients with stroke were randomized to the immediate group (IG): 4 weeks (4 w) BOOST +4 w CONTROL or the delayed group (DG): 4 w CONTROL +4 w BOOST, on top of their usual inpatient care program. The focused arm-hand BOOST program (1 h/day, 5x/week, 4 weeks) consisted of group exercises with focus on scapula-setting, core-stability, manipulation and complex ADL tasks. Additionally, 1 h per week the Armeo®Power (Hocoma AG, Switzerland) was used. The CONTROL intervention comprised a dose-matched program (24 one-hour sessions in 4 w) of lower limb strengthening exercises and general reconditioning. At baseline, after 4 and 8 weeks of training, the Fugl-Meyer assessment upper extremity (FMA-UE), action research arm test (ARAT), and stroke upper limb capacity scale (SULCS) were administered. Results: Eighteen participants (IG: n = 10, DG: n = 8) were included, with a median (IQR) time post stroke of 8.6 weeks (5-12). No adverse events were experienced. After 4 weeks of training, significant between-group differences were found for FMA-UE (p = 0.003) and SULCS (p = 0.033) and a trend for ARAT (p = 0.075) with median (IQR) change scores for the IG of 9 (7-16), 2 (1-3), and 12.5 (1-18), respectively, and for the DG of 0.5 (-3 to 3), 1 (0-1), and 1.5 (-1 to 9), respectively. In the IG, 80% of patients improved beyond the minimal clinical important difference of FMA-UE after 4 weeks, compared to none of the DG patients. Between 4 and 8 weeks of training, patients in the DG tend to show larger improvements when compared to the IG, however, between-group comparisons did not reach significance. Conclusions: Results of this pilot RCT showed that an intensive, specific arm-hand BOOST program, on top of usual care, is feasible and safe in the sub-acute phase post stroke and suggests positive, clinical meaningful effects on upper limb function, especially when delivered in the early sub-acute phase post stroke. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04584177.

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Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

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Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

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