post-stroke upper limb motor dysfunction
Conditions
Interventions
Conventional treatment group:Rehabilitation intervention therapy
SCS combined with conventional treatment group:Cervical spinal cord electrical stimulation combined with rehabilitation therapy
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.A single ischemic or hemorrhagic stroke leading to hemiplegia, with a course of more than or equal to 6 months and imaging evidence. 2.Age between 18 and 70 years old. 3.Unilateral upper limb hemiplegia, receiving regular rehabilitation treatment after stroke, with upper limb scores above 10 and below 45 in FMA-UE score. 4.The affected upper limb retains basic sensory function. 5.Be able to understand the research content and voluntarily sign a written informed consent form, and be able to cooperate in completing all evaluations during the research period.
Exclusion criteria
Exclusion criteria: 1.Subjects with any of the following conditions are not eligible to participate in this clinical trial:; 2.Serious systemic diseases (such as neurological disorders other than stroke, cancer, severe circulatory or respiratory diseases, liver and kidney failure, etc.) or other diseases that may cause motor or cognitive dysfunction in subjects; Serious complications (intolerance to surgery/anesthesia, cardiac and pulmonary instability, uncontrolled arrhythmia, etc.). 3.Previously implanted contraindicated devices (certain types of pacemakers/defibrillators, as well as other implanted medical devices, according to hospital/device instructions). 4.Women who are pregnant or breastfeeding; 5.Receive anticoagulant, antiplatelet, antispasmodic, or antiepileptic drug treatment before enrollment or during the study period; 6.The joint contracture is too severe to participate in the study after clinical evaluation; 7.Individuals with severe mental illness or cognitive impairment who are unable to cooperate with treatment or follow-up questionnaires; 8.Cases where MRI is not acceptable, such as severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Fugl Meyer Motor Function Assessment Scale for Upper Limbs after Intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in scores between the Modified Ashworth Scale (MAS) and maximum voluntary contraction (MVC);Changes in FMA-UE scores and differences between groups;Changes in motor-evoked potentials and somatosensory-evoked potentials;Changes in scale scores; clinical adverse events; | — |
Countries
China
Contacts
Public ContactXiao Lu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed