Post-stroke arm spasticity Nervous System Diseases
Conditions
Interventions
Current interventions as of 13/01/2026:
Stimulation with electrical pulses is anecdotally associated with relief from muscle stiffness (spasticity). Proof of the effectiveness of TENS stimulation is
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 13/01/2026: 1. Age 18 to 100 years 2. 2 or more 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 Previous participant inclusion criteria as of 08/01/2025: 1. Age 18 to 100 years 2. 2-26 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 Previous participant inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 13/01/2026: The following criteria will be reviewed and a final judgement made based on clinical experience by medically qualified study team investigators. Eligibility will be confirmed before randomization. The threshold for meeting criteria 1, 2, 3, 4, and 6 will be the degree to which, in the opinion of the investigator, it could significantly interfere with participation in the study: 1. Dermatological, rheumatologic, orthopaedic illnesses or muscle contractures 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. Uncontrolled epilepsy 7. All forms of implanted electrical/electronic device 8. Pregnancy 9. Confirmed inability to provide informed consent 10. Pre-existing upper limb spasticity unrelated to stroke 11. Previous acute contact dermatitis and/or known allergy to acrylates Previous key exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elbow muscle spasticity measured using a daily self-reported Numerical Rating Scale for Spasticity (NRS-S) for 7 days prior to Visits: 2 (Baseline), 4 (at 6 weeks (end of treatment-EOT)), 5 (6 weeks after EOT), 6 (12 weeks after EOT), and 7 (24 weeks after EOT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcomes as of 13/01/2026: The following secondary outcomes are assessed at visits 2 (Baseline), 4 (at 6 weeks (end of treatment-EOT)), 5 (6 weeks after EOT), 6 (12 weeks after EOT), and 7 (24 weeks after EOT): 1. Elbow muscle tone measured using the Modified Ashworth Scale (MAS) given by a therapist 2. Elbow muscle strength measured using the Medical Research Council (MRC) Strength test given by a therapist 3. Arm function measured using the Action Research Arm Test (ARAT) given by a therapist 4. Passive and low-level active arm function measured using a semi-structured interview using the Leeds Adult Spasticity Impact Scale (LASIS) 5. Generic Quality of Life measured using EuroQol’s EQ-5D-5L instrument Previous key secondary outcomes: The following secondary outcomes are assessed at visits 2 (Baseline), 4 (at 6 weeks (end of treatment-EOT)), 5 (6 weeks after EOT), 6 (12 weeks after EOT), and 7 (24 weeks after EOT): 1. Elbow muscle tone measured using the Modified Ashworth Scale (MAS) given by a therapist 2. Elbow muscle strength measured using the Medical Research Council (MRC) Strength test given by a therapist 3. Arm function measured using the Action Research Arm Test (ARAT) given by a therapist 4. Passive and low-level active arm function measured using a semi-structured interview using the Leeds Adult Spasticity Impact Scale (LASIS) 5. Generic Quality of Life measured using EuroQol’s EQ-5D-5L instrument 6. Spasticity-related Quality of Life, including spasticity-associated pain and fatigue,measured using the SQoL-6D measure | — |
Countries
England, United Kingdom
Outcome results
None listed