Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial
Abstract Introduction Post stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, a...
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-11-01
|
| Series: | BMC Neurology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12883-024-03635-x |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850061898230267904 |
|---|---|
| author | Ali Ali Avril D. McCarthy Mark Reeves Jamie Healey Louise Moody Adewale Adebajo Tim Good Simon Dixon Kathleen Baster Wendy Tindale Krishnan Padmakumari Sivaraman Nair |
| author_facet | Ali Ali Avril D. McCarthy Mark Reeves Jamie Healey Louise Moody Adewale Adebajo Tim Good Simon Dixon Kathleen Baster Wendy Tindale Krishnan Padmakumari Sivaraman Nair |
| author_sort | Ali Ali |
| collection | DOAJ |
| description | Abstract Introduction Post stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, and conventional electrical stimulation therapies are limited long term by habituation. We aim to investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES), that delivers temporally and spatially varying pattern of electrical stimulation, against transcutaneous electrical stimulation (TENS) and standard care at reducing PSES. Methods and design Overall, 297 people with PSES will be randomised (1:1:1) to one of 3 arms: Standard care (no electrical stimulation), TENS (conventional patterned electrical stimulation) or SHAPES (adaptive patterned electrical stimulation). Both SHAPES and TENS are delivered using a specially designed electrical stimulation sleeve used for 60 min each day for 6-weeks. Outcome measures are completed at baseline, end of treatment (EOT 6 weeks) and then 6-weeks, 12-weeks and 24-weeks after the end of treatment. Efficacy will be determined based on the proportion of participants experiencing meaningful improvement (18%) in the 7-day Numerical Rating Scale (NRS-S) for PSES, compared between both intervention arms and standard care, and between the two intervention groups. Measures of arm motor function (Action Research Arm Test, MRC scale), and quality of life (SQoL-6D, EQ-5D) will also be measured along with a parallel health economic evaluation. Discussion The results of the SHAPES trial will inform management of elbow spasticity after stroke. The SHAPES intervention is a low cost, self-administered intervention for the management of spasticity that can be used repeatedly, and if found to be more effective than TENS or control has the potential to be widely implemented in the UK NHS healthcare setting. Furthermore, despite the wide use of TENS in the management of spasticity, this study will provide critically required evidence regarding its efficacy. The trial has been registered with the ISRCTN registry (ISRCTN26060261). |
| format | Article |
| id | doaj-art-a01f45dc2d4646d2954192880d5d0cae |
| institution | DOAJ |
| issn | 1471-2377 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj-art-a01f45dc2d4646d2954192880d5d0cae2025-08-20T02:50:04ZengBMCBMC Neurology1471-23772024-11-012411910.1186/s12883-024-03635-xSheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trialAli Ali0Avril D. McCarthy1Mark Reeves2Jamie Healey3Louise Moody4Adewale Adebajo5Tim Good6Simon Dixon7Kathleen Baster8Wendy Tindale9Krishnan Padmakumari Sivaraman Nair10Sheffield Institute of Translational Neurosciences, University of SheffieldClinical Engineering, Sheffield Teaching Hospitals NHS Foundation TrustClinical Engineering, Sheffield Teaching Hospitals NHS Foundation TrustClinical Engineering, Sheffield Teaching Hospitals NHS Foundation TrustUniversity of CoventryDepartment of Rheumatology, Barnsley Hospital NHS Foundation Trust, BarnsleySchool of Health and Related Research (ScHARR), Faculty of Medicine, Dentistry and Health, The University of SheffieldSchool of Health and Related Research (ScHARR), Faculty of Medicine, Dentistry and Health, The University of SheffieldSchool of Health and Related Research (ScHARR), Faculty of Medicine, Dentistry and Health, The University of SheffieldClinical Engineering, Sheffield Teaching Hospitals NHS Foundation TrustDepartment of Neurosciences, Sheffield Teaching Hospitals NHS Foundation TrustAbstract Introduction Post stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, and conventional electrical stimulation therapies are limited long term by habituation. We aim to investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES), that delivers temporally and spatially varying pattern of electrical stimulation, against transcutaneous electrical stimulation (TENS) and standard care at reducing PSES. Methods and design Overall, 297 people with PSES will be randomised (1:1:1) to one of 3 arms: Standard care (no electrical stimulation), TENS (conventional patterned electrical stimulation) or SHAPES (adaptive patterned electrical stimulation). Both SHAPES and TENS are delivered using a specially designed electrical stimulation sleeve used for 60 min each day for 6-weeks. Outcome measures are completed at baseline, end of treatment (EOT 6 weeks) and then 6-weeks, 12-weeks and 24-weeks after the end of treatment. Efficacy will be determined based on the proportion of participants experiencing meaningful improvement (18%) in the 7-day Numerical Rating Scale (NRS-S) for PSES, compared between both intervention arms and standard care, and between the two intervention groups. Measures of arm motor function (Action Research Arm Test, MRC scale), and quality of life (SQoL-6D, EQ-5D) will also be measured along with a parallel health economic evaluation. Discussion The results of the SHAPES trial will inform management of elbow spasticity after stroke. The SHAPES intervention is a low cost, self-administered intervention for the management of spasticity that can be used repeatedly, and if found to be more effective than TENS or control has the potential to be widely implemented in the UK NHS healthcare setting. Furthermore, despite the wide use of TENS in the management of spasticity, this study will provide critically required evidence regarding its efficacy. The trial has been registered with the ISRCTN registry (ISRCTN26060261).https://doi.org/10.1186/s12883-024-03635-xStrokeSpasticityElectrical stimulationTENSSHAPESRCT |
| spellingShingle | Ali Ali Avril D. McCarthy Mark Reeves Jamie Healey Louise Moody Adewale Adebajo Tim Good Simon Dixon Kathleen Baster Wendy Tindale Krishnan Padmakumari Sivaraman Nair Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial BMC Neurology Stroke Spasticity Electrical stimulation TENS SHAPES RCT |
| title | Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial |
| title_full | Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial |
| title_fullStr | Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial |
| title_full_unstemmed | Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial |
| title_short | Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial |
| title_sort | sheffield adaptive patterned electrical stimulation shapes therapy for post stroke arm spasticity study protocol for a 3 arm a partially blinded randomised controlled trial |
| topic | Stroke Spasticity Electrical stimulation TENS SHAPES RCT |
| url | https://doi.org/10.1186/s12883-024-03635-x |
| work_keys_str_mv | AT aliali sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT avrildmccarthy sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT markreeves sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT jamiehealey sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT louisemoody sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT adewaleadebajo sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT timgood sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT simondixon sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT kathleenbaster sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT wendytindale sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial AT krishnanpadmakumarisivaramannair sheffieldadaptivepatternedelectricalstimulationshapestherapyforpoststrokearmspasticitystudyprotocolfora3armapartiallyblindedrandomisedcontrolledtrial |