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Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial.

ABSTRACT: Upper limb paresis is one of the most frequent and persistent impairments following stroke. Only 12-34% of stroke patients achieve full recovery of upper limb functioning, which seems to be required to habitually use the affected arm in daily tasks. Although the recovery of upper limb functioning is most pronounced during the first 4 weeks post stroke, there are few studies investigating the effect of rehabilitation during this critical time window. The purpose of this trial is to determine the effect of electrical somatosensory stimulation (ESS) initiated in the acute stroke phase on the recovery of upper limb functioning in a nonselected sample of stroke patients.A sample of 102 patients with upper limb paresis of varying degrees of severity is assigned to either the intervention or the control group using stratified random sampling. The intervention group receives ESS plus usual rehabilitation and the control group receives sham ESS plus usual rehabilitation. The intervention is applied as 1 h of ESS/sham ESS daily, followed by motor training of the affected upper limb. The ESS/sham ESS treatment is initiated within 7 days from stroke onset and it is delivered during hospitalization, but no longer than 4 weeks post stroke. The primary outcome is hand dexterity assessed by the Box and Block Test; secondary outcomes are the Fugl-Meyer Assessment, hand grip strength, pinch strength, perceptual threshold of touch, degree of pain, and modified Rankin Scale score. Outcome measurements are conducted at baseline, post intervention and at 6-month follow-up.Because of the wide inclusion criteria, we believe that the results can be generalized to the larger population of patients with a first-ever stroke who present with an upper limb paresis of varying severity. On the other hand, the sample size (n?=?102) may preclude subgroup analyses in such a heterogeneous sample. The sham ESS treatment totals a mere 2% of the active ESS treatment delivered to the intervention group per ESS session, and we consider that this dose is too small to induce a treatment effect.ClinicalTrials.gov, NCT02250365 . Registered on 18 September 2014.

SUBMITTER: Ghaziani E

PROVIDER: S-EPMC5324330 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial.

Ghaziani Emma E Ghaziani Emma E Couppé Christian C Henkel Cecilie C Siersma Volkert V Søndergaard Mette M Christensen Hanne H Magnusson S Peter SP

Trials 20170223 1

<h4>Background</h4>Upper limb paresis is one of the most frequent and persistent impairments following stroke. Only 12-34% of stroke patients achieve full recovery of upper limb functioning, which seems to be required to habitually use the affected arm in daily tasks. Although the recovery of upper limb functioning is most pronounced during the first 4 weeks post stroke, there are few studies investigating the effect of rehabilitation during this critical time window. The purpose of this trial i ...[more]

PMID: 28231811

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Project description:BackgroundRestorative Brain-Computer Interfaces (BCI) that combine motor imagery with visual feedback and functional electrical stimulation (FES) may offer much-needed treatment alternatives for patients with severely impaired upper limb (UL) function after a stroke.ObjectivesThis study aimed to examine if BCI-based training, combining motor imagery with FES targeting finger/wrist extensors, is more effective in improving severely impaired UL motor function than conventional therapy in the subacute phase after stroke, and if patients with preserved cortical-spinal tract (CST) integrity benefit more from BCI training.MethodsForty patients with severe UL paresis (< 13 on Action Research Arm Test (ARAT) were randomized to either a 12-session BCI training as part of their rehabilitation or conventional UL rehabilitation. BCI sessions were conducted 3-4 times weekly for 3-4 weeks. At baseline, Transcranial Magnetic Stimulation (TMS) was performed to examine CST integrity. The main endpoint was the ARAT at 3 months post-stroke. A binominal logistic regression was conducted to examine the effect of treatment group and CST integrity on achieving meaningful improvement. In the BCI group, electroencephalographic (EEG) data were analyzed to investigate changes in event-related desynchronization (ERD) during the course of therapy.ResultsData from 35 patients (15 in the BCI group and 20 in the control group) were analyzed at 3-month follow-up. Few patients (10/35) improved above the minimally clinically important difference of 6 points on ARAT, 5/15 in the BCI group, 5/20 in control. An independent-samples Mann-Whitney U test revealed no differences between the two groups, p = 0.382. In the logistic regression only CST integrity was a significant predictor for improving UL motor function, p = 0.007. The EEG analysis showed significant changes in ERD of the affected hemisphere and its lateralization only during unaffected UL motor imagery at the end of the therapy.ConclusionThis is the first RCT examining BCI training in the subacute phase where only patients with severe UL paresis were included. Though more patients in the BCI group improved relative to the group size, the difference between the groups was not significant. In the present study, preserved CTS integrity was much more vital for UL improvement than which type of intervention the patients received. Larger studies including only patients with some preserved CST integrity should be attempted.

Project description:BackgroundStroke is one of the most common neurological conditions that often leads to upper limb motor impairments, significantly affecting individuals' quality of life. Rehabilitation strategies are crucial in facilitating post-stroke recovery and improving functional independence. Functional Electrical Stimulation (FES) systems have emerged as promising upper limb rehabilitation tools, offering innovative neuromuscular reeducation approaches.ObjectiveThe main objective of this paper is to provide a comprehensive systematic review of the start-of-the-art functional electrical stimulation (FES) systems for upper limb neurorehabilitation in post-stroke therapy. More specifically, this paper aims to review different types of FES systems, their feasibility testing, or randomized control trials (RCT) studies.MethodsThe FES systems classification is based on the involvement of patient feedback within the FES control, which mainly includes "Open-Loop FES Systems" (manually controlled) and "Closed-Loop FES Systems" (brain-computer interface-BCI and electromyography-EMG controlled). Thus, valuable insights are presented into the technological advantages and effectiveness of Manual FES, EEG-FES, and EMG-FES systems.Results and discussionThe review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb functional movements, as measured by the FMA (Fugl-Meyer Assessment) (Manually controlled FES: mean difference = 5.6, 95% CI (3.77, 7.5), P < 0.001; BCI-controlled FES: mean difference = 5.37, 95% CI (4.2, 6.6), P < 0.001; EMG-controlled FES: mean difference = 14.14, 95% CI (11.72, 16.6), P < 0.001) and ARAT (Action Research Arm Test) (EMG-controlled FES: mean difference = 11.9, 95% CI (8.8, 14.9), P < 0.001) scores. Furthermore, the shortcomings, clinical considerations, comparison to non-FES systems, design improvements, and possible future implications are also discussed for improving stroke rehabilitation systems and advancing post-stroke recovery. Thus, summarizing the existing literature, this review paper can help researchers identify areas for further investigation. This can lead to formulating research questions and developing new studies aimed at improving FES systems and their outcomes in upper limb rehabilitation.

Project description:Abnormal upper arm-forearm muscle synergies after stroke are poorly understood. We investigated whether upper arm function primes paralyzed forearm muscles in chronic stroke patients after Brain-Machine Interface (BMI)-based rehabilitation. Shaping upper arm-forearm muscle synergies may support individualized motor rehabilitation strategies.Thirty-two chronic stroke patients with no active finger extensions were randomly assigned to experimental or sham groups and underwent daily BMI training followed by physiotherapy during four weeks. BMI sessions included desynchronization of ipsilesional brain activity and a robotic orthosis to move the paretic limb (experimental group, n = 16). In the sham group (n = 16) orthosis movements were random. Motor function was evaluated with electromyography (EMG) of forearm extensors, and upper arm and hand Fugl-Meyer assessment (FMA) scores. Patients performed distinct upper arm (e.g., shoulder flexion) and hand movements (finger extensions). Forearm EMG activity significantly higher during upper arm movements as compared to finger extensions was considered facilitation of forearm EMG activity. Intraclass correlation coefficient (ICC) was used to test inter-session reliability of facilitation of forearm EMG activity.Facilitation of forearm EMG activity ICC ranges from 0.52 to 0.83, indicating fair to high reliability before intervention in both limbs. Facilitation of forearm muscles is higher in the paretic as compared to the healthy limb (p<0.001). Upper arm FMA scores predict facilitation of forearm muscles after intervention in both groups (significant correlations ranged from R = 0.752, p = 0.002 to R = 0.779, p = 0.001), but only in the experimental group upper arm FMA scores predict changes in facilitation of forearm muscles after intervention (R = 0.709, p = 0.002; R = 0.827, p<0.001).Residual upper arm motor function primes recruitment of paralyzed forearm muscles in chronic stroke patients and predicts changes in their recruitment after BMI training. This study suggests that changes in upper arm-forearm synergies contribute to stroke motor recovery, and provides candidacy guidelines for similar BMI-based clinical practice.

Project description:BACKGROUND:Effective poststroke motor rehabilitation depends on repeated limb practice with voluntary efforts. An electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robot arm was designed for the multi-joint physical training on the elbow, the wrist, and the fingers. OBJECTIVES:To investigate the training effects of the device-assisted approach on subacute stroke patients and to compare the effects with those achieved by the traditional physical treatments. METHOD:This study was a pilot randomized controlled trial with a 3-month follow-up. Subacute stroke participants were randomly assigned into two groups, and then received 20-session upper limb training with the EMG-driven NMES-robotic arm (NMES-robot group, n?=?14) or the time-matched traditional therapy (the control, n?=?10). For the evaluation of the training effects, clinical assessments including Fugl-Meyer Assessment (FMA), Modified Ashworth Score (MAS), Action Research Arm Test (ARAT), and Function Independence Measurement (FIM) were conducted before, after the rehabilitation training, and 3?months later. Session-by-session EMG parameters in the NMES-robot group, including normalized co-contraction Indexes (CI) and EMG activation level of target muscles, were used to monitor the progress in muscular coordination patterns. RESULTS:Significant improvements were obtained in FMA (full score and shoulder/elbow), ARAT, and FIM [P?<?0.001, effect sizes (EFs)?>?0.279] for both groups. Significant improvement in FMA wrist/hand was only observed in the NMES-robot group (P?<?0.001, EFs?=?0.435) after the treatments. Significant reduction in MAS wrist was observed in the NMES-robot group after the training (P?<?0.05, EFs?=?0.145) and the effects were maintained for 3?months. MAS scores in the control group were elevated following training (P?<?0.05, EFs?>?0.24), and remained at an elevated level when assessed 3?months later. The EMG parameters indicated a release of muscle co-contraction in the muscle pairs of biceps brachii and flexor carpi radialis and biceps brachii and triceps brachii, as well as a reduction of muscle activation level in the wrist flexor in the NMES-robot group. CONCLUSION:The NMES-robot-assisted training was effective for early stroke upper limb rehabilitation and promoted independence in the daily living comparable to the traditional physical therapy. It could achieve higher motor outcomes at the distal joints and more effective release in muscle tones than the traditional therapy. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, identifier NCT02117089; date of registration: April 10, 2014.

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Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial.

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Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial.

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