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Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.

ABSTRACT: BACKGROUND:Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial. METHODS:Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3?L) measured at baseline, 3?months and 12?months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods. DISCUSSION:The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.

SUBMITTER: Milte R

PROVIDER: S-EPMC7254740 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.

Milte Rachel R Ratcliffe Julie J Ada Louise L English Coralie C Crotty Maria M Lannin Natasha A NA

BMC health services research 20200527 1

<h4>Background</h4>Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial.<h4>Methods</h4>Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to co ...[more]

PMID: 32460773

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Project description:Upper limb motor deficits in severe stroke survivors often remain unresolved over extended time periods. Novel neurotechnologies have the potential to significantly support upper limb motor restoration in severely impaired stroke individuals. Here, we review recent controlled clinical studies and reviews focusing on the mechanisms of action and effectiveness of single and combined technology-aided interventions for upper limb motor rehabilitation after stroke, including robotics, muscular electrical stimulation, brain stimulation and brain computer/machine interfaces. We aim at identifying possible guidance for the optimal use of these new technologies to enhance upper limb motor recovery especially in severe chronic stroke patients. We found that the current literature does not provide enough evidence to support strict guidelines, because of the variability of the procedures for each intervention and of the heterogeneity of the stroke population. The present results confirm that neurotechnology-aided upper limb rehabilitation is promising for severe chronic stroke patients, but the combination of interventions often lacks understanding of single intervention mechanisms of action, which may not reflect the summation of single intervention's effectiveness. Stroke rehabilitation is a long and complex process, and one single intervention administrated in a short time interval cannot have a large impact for motor recovery, especially in severely impaired patients. To design personalized interventions combining or proposing different interventions in sequence, it is necessary to have an excellent understanding of the mechanisms determining the effectiveness of a single treatment in this heterogeneous population of stroke patients. We encourage the identification of objective biomarkers for stroke recovery for patients' stratification and to tailor treatments. Furthermore, the advantage of longitudinal personalized trial designs compared to classical double-blind placebo-controlled clinical trials as the basis for precise personalized stroke rehabilitation medicine is discussed. Finally, we also promote the necessary conceptual change from 'one-suits-all' treatments within in-patient clinical rehabilitation set-ups towards personalized home-based treatment strategies, by adopting novel technologies merging rehabilitation and motor assistance, including implantable ones.

Project description:Introduction Robotic therapy allow to propose sessions of controlled and identical exercises, customizing settings, and characteristics on the individual patient. The effectiveness of robotic assisted therapy is still under study and the use of robots in clinical practice is still limited. Moreover, the possibility of treatment at home allows to reduce the economic costs and time to be borne by the patient and the caregiver and is a valid tool during periods of pandemic such as covid. The aim of this study is to assess whether a robotic home-based treatment rehabilitation using the iCONE robotic device has effects on a stroke population, despite the chronic condition of patients involved and the absence of a therapist next to the patient while performing the exercises. Materials and methods All patients underwent an initial (T0) and final (T1) assessment with the iCONE robotic device and clinical scales. After T0 evaluation, the robot was delivered to the patient's home for 10 days of at-home treatment (5 days a week for 2 weeks). Results Comparison between T0 and T1 evaluations revealed some significant improvements in robot-evaluated indices such as Independence and Size for the Circle Drawing exercise and Movement Duration for Point-to-Point exercise, but also in the MAS of the elbow. From the analysis of the acceptability questionnaire, a general appreciation of the robot emerged: patients spontaneously asked for the addition of further sessions and to continue therapy. Discussion Telerehabilitation of patients suffering from a chronic stroke is an area that is still little explored. From our experience, this is one of the first studies to carry out a telerehabilitation with these characteristics. The use of robots can become a method to reduce the rehabilitation health costs, to ensure continuity of care, and to arrive in more distant places or where the availability of resources is limited. Conclusion From the data obtained, this rehabilitation seems to be promising for this population. Moreover, promoting the recovery of the upper limb, iCONE can improve patient's quality of life. It would be interesting to conduct RCT studies to compare a conventional treatment in structure with a robotic telematics treatment.

Project description:Even though robotic rehabilitation is very useful to improve motor function, there is no conclusive evidence on its role in reducing post-stroke spasticity. Focal muscle vibration (MV) is instead very useful to reduce segmental spasticity, with a consequent positive effect on motor function. Therefore, it could be possible to strengthen the effects of robotic rehabilitation by coupling MV. To this end, we designed a pilot randomized controlled trial (Clinical Trial NCT03110718) that included twenty patients suffering from unilateral post-stroke upper limb spasticity. Patients underwent 40 daily sessions of Armeo-Power training (1 hour/session, 5 sessions/week, for 8 weeks) with or without spastic antagonist MV. They were randomized into two groups of 10 individuals, which received (group-A) or not (group-B) MV. The intensity of MV, represented by the peak acceleration (a-peak), was calculated by the formula (2?f)2A, where f is the frequency of MV and A is the amplitude. Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio (HMR) were the primary outcomes measured before and after (immediately and 4 weeks later) the end of the treatment. In all patients of group-A, we observed a greater reduction of MAS (p = 0.007, d = 0.6) and HMR (p<0.001, d = 0.7), and a more evident increase of SICI (p<0.001, d = 0.7) up to 4 weeks after the end of the treatment, as compared to group-B. Likewise, group-A showed a greater function outcome of upper limb (Functional Independence Measure p = 0.1, d = 0.7; Fugl-Meyer Assessment of the Upper Extremity p = 0.007, d = 0.4) up to 4 weeks after the end of the treatment. A significant correlation was found between the degree of MAS reduction and SICI increase in the agonist spastic muscles (p = 0.004). Our data show that this combined rehabilitative approach could be a promising option in improving upper limb spasticity and motor function. We could hypothesize that the greater rehabilitative outcome improvement may depend on a reshape of corticospinal plasticity induced by a sort of associative plasticity between Armeo-Power and MV.

Project description:Introduction: Spasticity is the main complication of many upper motor neuron disorders. Many studies describe neuro-orthopedic surgeries for the correction of joint and limb deformities due to spasticity, though less in the upper extremity. The bulk of care provided to patients with spasticity is provided by rehabilitation clinicians, however, few of the surgical outcomes have been summarized or appraised in the rehabilitation literature. Objective: To review the literature for neuro-orthopedic surgical techniques in the upper limb and evaluate the level of evidence for their efficacy in adult patients with spasticity. Method: Electronic databases of MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews were searched for English, French as well as Farsi languages human studies from 1980 to July 2, 2020. After removing duplicated articles, 2,855 studies were screened and 80 were found to be included based on the criteria. The studies were then divided into two groups, with 40 in each trial and non-trial. The results of the 40 trial articles were summarized in three groups: shoulder, elbow and forearm, and wrist and finger, and each group was subdivided based on the types of intervention. Results: The level of evidence was evaluated by Sackett's approach. There were no randomized control trial studies found. About, 4 studies for shoulder, 8 studies for elbow and forearm, 26 studies for wrist and finger (including 4 for the thumb in palm deformity), and 2 systematic reviews were found. Around, two out of 40 trial articles were published in the rehabilitation journals, one systematic review in Cochrane, and the remaining 38 were published in the surgical journals. Conclusion: Most surgical procedures are complex, consisting of several techniques based on the problems and goals of the patient. This complexity interferes with the evaluation of every single procedure. Heterogenicity of the participants and the absence of clinical trial studies are other factors of not having a single conclusion. This review reveals that almost all the studies suggested good results after the surgery in carefully selected cases with goals of reducing spasticity and improvement in function, pain, hygiene, and appearance. A more unified approach and criteria are needed to facilitate a collaborative, evidence-based, patient referral, and surgical selection pathway.

Project description:BackgroundAction observation (AO) is a physical rehabilitation approach that facilitates the occurrence of neural plasticity through the activation of the mirror-neural system, promoting motor recovery in people with stroke.ObjectivesTo assess whether AO enhances upper limb motor function in people with stroke.Search methodsWe searched the Cochrane Stroke Group Trials Register (last searched 18 May 2021), the Cochrane Central Register of Controlled Trials (18 May 2021), MEDLINE (1946 to 18 May 2021), Embase (1974 to 18 May 2021), and five additional databases. We also searched trial registries and reference lists.Selection criteriaRandomized controlled trials (RCTs) of AO alone or associated with physical practice in adults after stroke. The primary outcome was upper limb (arm and hand) motor function. Secondary outcomes included dependence on activities of daily living (ADL), motor performance, cortical activation, quality of life, and adverse effects.Data collection and analysisTwo review authors independently selected trials according to the predefined inclusion criteria, extracted data, assessed risk of bias using RoB 1, and applied the GRADE approach to assess the certainty of the evidence. The reviews authors contacted trial authors for clarification and missing information.Main resultsWe included 16 trials involving 574 individuals. Most trials provided AO followed by the practice of motor actions. Training varied between 1 day and 8 weeks of therapy, 10 to 90 minutes per session. The time of AO ranged from 1 minute to 10 minutes for each motor action, task or movement observed. The total number of motor actions ranged from 1 to 3. Control comparisons included sham observation, physical therapy, and functional activity practice.Primary outcomesAO improved arm function (standardized mean difference (SMD) 0.39, 95% confidence interval (CI) 0.17 to 0.61; 11 trials, 373 participants; low-certainty evidence); and improved hand function (mean difference (MD) 2.76, 95% CI 1.04 to 4.49; 5 trials, 178 participants; low-certainty evidence).Secondary outcomesAO did not improve ADL performance (SMD 0.37, 95% CI -0.34 to 1.08; 7 trials, 302 participants; very low-certainty evidence), or quality of life (MD 5.52, 95% CI -30.74 to 41.78; 2 trials, 30 participants; very low-certainty evidence). We were unable to pool the other secondary outcomes (motor performance and cortical activation). Only two trials reported adverse events without significant adverse effects.Authors' conclusionsThe effects of AO are small for arm function compared to any control group; for hand function the effects are large, but not clinically significant. For both, the certainty of evidence is low. There is no evidence of benefit or detriment from AO on ADL and quality of life of people with stroke; however, the certainty of evidence is very low. As such, our confidence in the effect estimate is limited because it will likely change with future research.

Dataset Information

Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.

Publications

Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.

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