A new therapy for post-stroke arm spasticity: Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) - a co-designed system improvement followed by a powered multi-arm randomised control trial.

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 297 人开始时间: 2023年6月29日最近更新: 2023年7月10日

适应症

试验速览

2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36001089/ Overview of the usability engineering process (added 28/06/2023)

•1. Age 18 to 100 years
•2. 2-16 weeks after stroke
•3. Weakness of elbow extension of MRC grade 4 below
•4. Spasticity of the elbow, of grade-1 or more on the modified Ashworth scale of elbow flexion

•The following criteria will be reviewed and a final judgement made based on clinical experience by medically qualified study team investigators (Neurologists at Consultant or Registrar level). Eligibility will be confirmed before randomization. The threshold for meeting criteria 1, 2, 3, 4, and 7 will be the degree to which, in the opinion of the investigator, it could significantly interfere with participation in the study:
•1. Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with elbow movement
•2. Pre-existing severe systemic disorders like cardiovascular disease, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, psychiatric illness including severe alcohol or drug abuse and depression
•3. Inability to perform the baseline assessments
•4. Severe tactile hypersensitivity
•5. Participation in other spasticity-related studies
•6. Within 12 weeks of receiving Botulinum toxin injections
•7. Uncontrolled epilepsy
•8. All forms of implanted electrical/electronic device
•9. Pregnancy
•10. Inability to provide informed consent
•11. Pre-existing upper limb spasticity
•12. Previous acute contact dermatitis and/or known allergy to acrylates

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