Combating sarcopenia in geriatric rehabilitation patients: study protocol of the EMPOWER-GR observational cohort, sarcopenia awareness survey and randomised controlled feasibility trial.

INTRODUCTION: Sarcopenia is highly prevalent in geriatric rehabilitation patients. Resistance exercise training (RET) combined with protein supplementation is recommended to increase muscle mass and strength in older adults. However, sarcopenia awareness, feasibility to diagnose and treat sarcopenia, and efficacy of treatment in geriatric rehabilitation patients remain to be established. METHODS AND ANALYSIS: Enhancing Muscle POWER in Geriatric Rehabilitation (EMPOWER-GR) encompasses four pillars: (1) an observational cohort study of 200 geriatric rehabilitation inpatients determining sarcopenia prevalence, functional and nutritional status at admission; (2) a survey among these 200 patients and 500 healthcare professionals and semistructured interviews in 30 patients and 15 carers determining sarcopenia awareness and barriers/enablers regarding diagnostics and treatment; (3) a feasibility, single-centre, randomised, controlled, open-label, two parallel-group trial in 80 geriatric rehabilitation patients with sarcopenia. The active group (n=40) receives three RET sessions per week and a leucine and vitamin D-enriched whey protein-based oral nutritional supplement two times per day in combination with usual care for 13 weeks. The control group (n=40) receives usual care. Primary outcomes are feasibility (adherence to the intervention, dropout rate, overall feasibility) and change from baseline in absolute muscle mass at discharge and week 13. Secondary outcomes are feasibility (participation rate) and change from baseline at discharge and week 13 in relative muscle mass, muscle strength, physical and functional performance, mobility, nutritional status, dietary intake, quality of life and length of stay; institutionalisation and hospitalisation at 6 months and mortality at 6 months and 2 years; (4) knowledge sharing on sarcopenia diagnosis and treatment. ETHICS AND DISSEMINATION: Ethical exemption was received for the observational cohort study, ethics approval was received for the randomised controlled trial. Results will be disseminated through publications in scientific peer-reviewed journals, conferences and social media. TRIAL REGISTRATION NUMBER: NL9444.

Computerised patient-specific prediction of the recovery profile of upper limb capacity within stroke services: the next step.

INTRODUCTION: Predicting upper limb capacity recovery is important to set treatment goals, select therapies and plan discharge. We introduce a prediction model of the patient-specific profile of upper limb capacity recovery up to 6 months poststroke by incorporating all serially assessed clinical information from patients. METHODS: Model input was recovery profile of 450 patients with a first-ever ischaemic hemispheric stroke measured using the Action Research Arm Test (ARAT). Subjects received at least three assessment sessions, starting within the first week until 6 months poststroke. We developed mixed-effects models that are able to deal with one or multiple measurements per subject, measured at non-fixed time points. The prediction accuracy of the different models was established by a fivefold cross-validation procedure. RESULTS: A model with only ARAT time course, finger extension and shoulder abduction performed as good as models with more covariates. For the final model, cross-validation prediction errors at 6 months poststroke decreased as the number of measurements per subject increased, from a median error of 8.4 points on the ARAT (Q1-Q3:1.7-28.1) when one measurement early poststroke was used, to 2.3 (Q1-Q3:1-7.2) for seven measurements. An online version of the recovery model was developed that can be linked to data acquisition environments. CONCLUSION: Our innovative dynamic model can predict real-time, patient-specific upper limb capacity recovery profiles up to 6 months poststroke. The model can use all available serially assessed data in a flexible way, creating a prediction at any desired moment poststroke, stand-alone or linked with an electronic health record system.

The effect of cerebellar transcranial direct current stimulation to improve standing balance performance early post-stroke, study protocol of a randomized controlled trial.

RATIONALE: Restoration of adequate standing balance after stroke is of major importance for functional recovery. POstural feedback ThErapy combined with Non-invasive TranscranIAL direct current stimulation (tDCS) in patients with stroke (POTENTIAL) aims to establish if cerebellar tDCS has added value in improving standing balance performance early post-stroke. METHODS: Forty-six patients with a first-ever ischemic stroke will be enrolled in this double-blind controlled trial within five weeks post-stroke. All patients will receive 15 sessions of virtual reality-based postural feedback training (VR-PFT) in addition to usual care. VR-PFT will be given five days per week for 1 h, starting within five weeks post-stroke. During VR-PFT, 23 patients will receive 25 min of cerebellar anodal tDCS (cb_tDCS), and 23 patients will receive sham stimulation. STUDY OUTCOME: Clinical, posturographic, and neurophysiological measurements will be performed at baseline, directly post-intervention, two weeks post-intervention and at 15 weeks post-stroke. The primary outcome measure will be the Berg Balance Scale (BBS) for which a clinical meaningful difference of six points needs to be established between the intervention and control group at 15 weeks post-stroke. DISCUSSION: POTENTIAL will be the first proof-of-concept randomized controlled trial to assess the effects of VR-PFT combined with cerebellar tDCS in terms of standing balance performance in patients early post-stroke. Due to the combined clinical, posturographical and neurophysiological measurements, this trial may give more insights in underlying post-stroke recovery processes and whether these can be influenced by tDCS.

Comprehensive neuromechanical assessment in stroke patients: reliability and responsiveness of a protocol to measure neural and non-neural wrist properties.

BACKGROUND: Understanding movement disorder after stroke and providing targeted treatment for post stroke patients requires valid and reliable identification of biomechanical (passive) and neural (active and reflexive) contributors. Aim of this study was to assess test-retest reliability of passive, active and reflexive parameters and to determine clinical responsiveness in a cohort of stroke patients with upper extremity impairments and healthy volunteers. METHODS: Thirty-two community-residing chronic stroke patients with an impairment of an upper limb and fourteen healthy volunteers were assessed with a comprehensive neuromechanical assessment protocol consisting of active and passive tasks and different stretch reflex-eliciting measuring velocities, using a haptic manipulator and surface electromyography of wrist flexor and extensor muscles (Netherlands Trial Registry number NTR1424). Intraclass correlation coefficients (ICC) and Standard Error of Measurement were calculated to establish relative and absolute test-retest reliability of passive, active and reflexive parameters. Clinical responsiveness was tested with Kruskal Wallis test for differences between groups. RESULTS: ICC of passive parameters were fair to excellent (0.45 to 0.91). ICC of active parameters were excellent (0.88-0.99). ICC of reflexive parameters were fair to good (0.50-0.74). Only the reflexive loop time of the extensor muscles performed poor (ICC 0.18). Significant differences between chronic stroke patients and healthy volunteers were found in ten out of fourteen parameters. CONCLUSIONS: Passive, active and reflexive parameters can be assessed with high reliability in post-stroke patients. Parameters were responsive to clinical status. The next step is longitudinal measurement of passive, active and reflexive parameters to establish their predictive value for functional outcome after stroke.