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Effects of Neuromuscular Electrical Stimulation on Plantarflexors Spasticity, Gait Performance, and Self-Reported Health Outcomes in People With Chronic Stroke: A Study Protocol for a Double-Blinded Randomized Clinical Trial.

ABSTRACT: Introduction: Rehabilitation approaches have been used for people with stroke to decrease spasticity and improve functions, but little is known about the effect of neuromuscular electrical stimulation (NMES) in this population. Therefore, the primary purpose of this study was to establish a protocol for a double-blinded randomized clinical trial to examine using NMES on plantarflexors spasticity, dorsiflexor muscle strength, physical functions, and self-reported health outcomes in people with chronic stroke in Saudi Arabia. Material and Methods: This randomized clinical trial with two arms and double-blinded registered in ClinicalTrials (NCT04673045) will enroll 44 participants with chronic stroke and randomized them into either the experimental group (EG), including electrical stimulation (ES) with conventional therapy or the control sham group (NMES_sham) including placebo electrical stimulation with conventional therapy. The frequency will be set at 80 Hz for 30 min. The intervention will be three times a week for 4 weeks for both groups. Data collection for pre- and post-intervention outcomes will include measurements for the primary outcomes including paretic limb (plantarflexor spasticity, ankle range of motion, and dorsiflexor muscles strength), and gait speed using 10-m walk test (10-MWT). The secondary outcomes including mobility function using Timed Up and Go (TUG), walking endurance using 6 Minutes Walk Test (6-MWT), activity of daily living using the Arabic version of Barthel Index (BI), and self-reported health measures such as quality of life using the Medical Outcomes Survey (Short Form 36, SF-36), physical activity using Rapid Assessment of Physical Activity (RAPA), depression symptoms using Patient Health Questionnaire-9 (PHQ-9), fatigue level using Fatigue Severity Scale (FSS), and risk of fall using Fall Efficacy Scale International (FES-I). An independent t-test will be utilized to examine the effect of the intervention on the outcome measures. Results: The recruitment has started and is ongoing. Conclusions: Using 4 weeks of NMES will provide information about its effect in improving plantarflexor spasticity, dorsiflexor muscles strength, gait speed, mobility functions, and other self-reported health outcomes in people with chronic stroke when compared to NMES_sham.

SUBMITTER: Almutairi SM

PROVIDER: S-EPMC8672659 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Neuromuscular electrical stimulation (NMES) has been used to improve muscle strength and decrease spasticity of the ankle joint in stroke patients. However, it is unclear how NMES could influence dynamic spasticity of ankle plantarflexors and gait asymmetry during walking. The study aimed to evaluate the effects of applying NMES over ankle dorsiflexors or plantarflexors on ankle control during walking and gait performance in chronic stroke patients. Twenty-five stroke participants with inadequate ankle control were recruited and randomly assigned to an experimental or a control group. The experimental group received 20 minutes of NMES on either the tibialis anterior muscle (NMES-TA) or the medial gastrocnemius muscle (NMES-MG). The control group received 20 minutes of range of motion and stretching exercises. After the 20 minutes of NMES or exercises, all participants received ambulation training for 15 minutes. Training sessions occurred 3 times per week for 7 weeks. The pre- and post-training assessments included spatio-temporal parameters, ankle range of motion, and dynamic spasticity of ankle plantarflexors during walking. Muscle strength of ankle dorsiflexors and plantarflexors as well as static spasticity of ankle plantarflexors were also examined. The results showed that the static and dynamic spasticity of ankle plantarflexors of the NMES-TA group were significantly decreased after training. Reduction in dynamic spasticity of ankle plantarflexors of the NMES-TA group was significantly greater than that of the NMES-MG group. When compared to the control group, the NMES-TA group had greater improvements in spatial asymmetry, ankle plantarflexion during push off, and muscle strength of ankle dorsiflexors, and the NMES-MG group showed a significant decrease in temporal asymmetry. In summary, NMES on ankle dorsiflexors could be an effective management to enhance gait performance and ankle control during walking in chronic stroke patients. NMES on ankle plantarflexors may improve gait symmetry.

Project description:BackgroundMany stroke survivors have significant long-term gait impairment, often involving foot drop. Current physiotherapies provide limited recovery. Orthoses substitute for ankle strength, but they provide no lasting therapeutic effect. Brain-computer interface (BCI)-controlled functional electrical stimulation (FES) is a novel rehabilitative approach that may generate permanent neurological improvements. This study explores the safety and feasibility of a foot-drop-targeted BCI-FES physiotherapy in chronic stroke survivors.MethodsSubjects (n?=?9) operated an electroencephalogram-based BCI-FES system for foot dorsiflexion in 12 one-hour sessions over four weeks. Gait speed, dorsiflexion active range of motion (AROM), six-minute walk distance (6MWD), and Fugl-Meyer leg motor (FM-LM) scores were assessed before, during, and after therapy. The primary safety outcome measure was the proportion of subjects that deteriorated in gait speed by ?0.16 m/s at one week or four weeks post-therapy. The secondary outcome measures were the proportion of subjects that experienced a clinically relevant decrease in dorsiflexion AROM (?2.5°), 6MWD (?20 %), and FM-LM score (?10 %) at either post-therapy assessment.ResultsNo subjects (0/9) experienced a clinically significant deterioration in gait speed, dorsiflexion AROM, 6MWT distance, or FM-LM score at either post-therapy assessment. Five subjects demonstrated a detectable increase (?0.06 m/s) in gait speed, three subjects demonstrated a detectable increase (?2.5°) in dorsiflexion AROM, five subjects demonstrated a detectable increase (?10 %) in 6MWD, and three subjects demonstrated a detectable increase (?10 %) in FM-LM. Five of the six subjects that exhibited a detectable increase in either post-therapy gait speed or 6MWD also exhibited significant (p?<?0.01 using a Mann-Whitney U test) increases in electroencephalogram event-related synchronization/desynchronization. Additionally, two subjects experienced a clinically important increase (?0.16 m/s) in gait speed, and four subjects experienced a clinically important increase (?20 %) in 6MWD. Linear mixed models of gait speed, dorsiflexion AROM, 6MWD, and FM-LM scores suggest that BCI-FES therapy is associated with an increase in lower motor performance at a statistically, yet not clinically, significant level.ConclusionBCI-FES therapy is safe. If it is shown to improve post-stroke gait function in future studies, it could provide a new gait rehabilitation option for severely impaired patients. Formal clinical trials are warranted.

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Effects of Neuromuscular Electrical Stimulation on Plantarflexors Spasticity, Gait Performance, and Self-Reported Health Outcomes in People With Chronic Stroke: A Study Protocol for a Double-Blinded Randomized Clinical Trial.

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