A randomised trial of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) as a new therapy for post-stroke arm spasticity

INTERVENTION: Stimulation with electrical pulses is anecdotally associated with relief from muscle stiffness (spasticity). Proof of the effectiveness of TENS stimulation is not currently available but will be tested in this study compared to usual care. One limitation of TENS is the fixed pulsation points. It is expected that moving the pulse points in a spatially varying pattern (SHAPES stimulation) will confer an increased and/or longer‐lasting benefit compared to TENS and usual care. The benefit will be measured by the change in the 7‐day average NRS‐S score from baseline with an 18% improvement being considered a treatment success and the proportion of successes per group being the key comparison outcome. Each of the primary null hypotheses will take the form: ? There is no association between the treatment group and success. Each of the primary alternative hypotheses will take the form: ? There is a significant association between the treatment group and success. Secondary analysis for ARAT, MAS, MRC Strength, LASIS, EQ‐5D‐5L and SQoL‐6D will take the following hypotheses: H0: There is no significant difference between treatment groups HA: There is a significant difference between treatment groups Stroke survivors with arm weakness and elbow spasticity as indicated in the trial inclusion criteria who consent to participate will be randomised into 1 of 3 groups: 1. SHAPES stimulation for 60 minutes per day for 6 weeks plus usual care 2. TENS stimulation for 60 minutes per day for 6 weeks plus usual care 3. Usual care only Subject to meeting inclusion /ex CONDITION: Post‐stroke arm spasticity ; Nervous System Diseases PRIMARY OUTCOME: ; 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); 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 SECONDARY OUTCOME: ; 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;