IntroductionOur previous studies have proposed the bodyweight support–t’ai chi (BWS-TC) footwork training for stroke survivors with severe motor dysfunction and fear of falling, and have proven its positive effects for motor function. Transcranial direct current stimulation (tDCS) provides a non-invasive and safe way to modulate neuronal activity and provoke neuroplastic changes and to improve the motor function of stroke survivors. However, it is unclear whether the integration of BWS-TC and tDCS has synergistic effects on improving motor function of the stroke survivors.Methods and analysisThis study will be an assessor-blinded randomised controlled trial involving 12-week intervention and 6-month follow-up. One hundred and thirty-five individuals with stroke will be randomly divided in a ratio of 1:1:1 into three groups. Control group A, control group B and intervention group C will receive tDCS and conventional rehabilitation programmes (CRPs), BWS-TC and CRP, tDCS-BWS-TC and CRP for 12 weeks, respectively. The primary outcome measures will include the efficacy (Fugl-Meyer Assessment), acceptability and safety of these interventions. The secondary outcome measures will include balance ability (ie, limits of stability and modified clinical test of sensory integration), walking function, brain structure and function, risk of falling, Barthel Index and 36-Item Short Form Survey. All outcomes will be assessed at baseline, 6 and 12 weeks during intervention, and 1, 3 and 6 months during the follow-up period. Two-way analysis of variance with repeated measures will be applied to examine the main effects of the group and the time factor and group–time interaction effects for all outcome measures.Ethics and disseminationEthics approval was obtained from the ethics committee of the Shanghai Seventh People’s Hospital (2021-7th-HIRB-017). The results of the study will be published in a peer-reviewed journal and presented at scientific conferences.Trial registration numberChiCTR2200059329.
Background: Quadriceps training is necessary in function, activity of daily living and quality of life for patients with knee osteoarthritis (KOA) but it did not reduce the rate of surgical treatment (replacement of knee) for end-stage KOA in the long term. This may be related to brain structure changes and maladaptive plasticity in KOA patients. Transcranial magnetic stimulation (TMS), as a non-invasive brain stimulation technique, which uses magnetic pulse on the central nervous system, stimulates the excitability of nerve cells, enhances the functional connectivity of brain regions and improves maladaptive plasticity. However,the therapeutic effect of two rehabilitation techniques combination in patients with KOA remains unclear. Therefore, the purpose of this study is to investigate whether the high-frequency rTMS combined with quadriceps strength training can improve the function in KOA more effectively than quadriceps training alone and explore the brain mechanism of this combined rehabilitation. Methods: This study is an assessor-blind, sham-controlled, randomized controlled trial involving 12 weeks intervention and 6 months follow-up. One hundred and twelve participants with KOA will be received usual care management and randomized into four subgroups including quadriceps strength training (QT); high-frequency rTMS training (HT); sham rTMS and quadriceps strength training (ST+Q); high-frequency rTMS and quadriceps strength training (HT+Q). The rehabilitation interventions in four groups will be carried out 5 days per week for a total of 12 weeks. All outcomes will be measured at baseline, 4 weeks, 8 weeks, and 12 weeks during intervention and 1 months, 3 months and 6 months during follow-up period. The primary outcomes are visual analog scale (VAS) and isokinetic muscle strength test. Secondary outcomes are include Knee Injury and Osteoarthritis Outcome Score (KOOS),36-Item Short-Form Health Survey (SF-36), rTMS and magnetic resonance imaging (MRI). Discussion: The study will provide evidence for the effects and brain mechanism of high frequency rTMS on improving function in KOA patients. High frequency rTMS can be added into the muscle training program for KOA patients as a supplementary therapy content if it is proved to be effective. Trial registration: Chinese Clinical Trial Registry ChiCTR2300067617. Registered on Jan.13,2023.
Background Customized multi-muscle Functional Electrical Stimulation (FES) based on muscle synergy of the healthy adults, may provide opportunity for improve the upper limb motor function of the stroke survivors. Additionally, synergy-based FES combined with Robotic-assisted Therapy (RAT) can be a novel and more effective therapy for improving upper limb function of the stroke survivors from the perspective of synergistic enhancement. However, few studies examined the effectiveness of combined synergy-based FES and RAT for stroke upper limb function improvement, especially for the motor control evaluated by the Reach-To-Grasp (RTG) behavior. Methods This study will be an assessor-blind randomized controlled trial involving 12-week intervention and 6-month follow-up. The stratified randomization will be used to randomly assign the 120 stroke patients into FES + conventional rehabilitation programs (CRP) group, RAT + CRP group and FES-RAT + CRP group equally. Intervention will be 3 sessions a week, with a total of 36 sessions. The primary outcome measurements will include Fugl-Meyer Assessment and Biomechanical Assessment of RTG behavior. The secondary outcome measurements will include Quality of life and Brain Neuroplasticity assessment by MRI. There are five time points for the evaluation, including baseline, 6 weeks and 12 weeks from the start of treatment, and 3 months, 6 months following the end of treatment. Two-way of variance with repeated measures will be applied to examine the main effects of the group, the time factor and group-time interaction effects. Discussion The results of the study protocol will provide evidence with high quality for integrated synergy-based FES and RAT, and synergy-based FES alone, and guide significance for design more effective treatment methods in stroke rehabilitation. Trial registration number ChiCTR2300071588.
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