Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol...

Area of Science:

• Neurology
• Rehabilitation Medicine
• Biomedical Engineering

Background:

• Post-stroke elbow spasticity (PSES) significantly impairs functional recovery and quality of life in over a third of stroke survivors.
• Current treatments like drugs and botulinum toxin have limitations including side effects, high cost, and limited long-term efficacy.
• Conventional electrical stimulation therapies can be limited by long-term habituation.

Purpose of the Study:

• To investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) in reducing PSES.
• To compare SHAPES against transcutaneous electrical stimulation (TENS) and standard care.
• To evaluate the impact of SHAPES on arm motor function and quality of life.

Main Methods:

• A randomized controlled trial involving 297 participants with PSES, allocated 1:1:1 to standard care, TENS, or SHAPES.
• Interventions delivered daily for 60 minutes over 6 weeks using a specialized electrical stimulation sleeve.
• Outcome measures assessed at baseline, end of treatment, and at 6, 12, and 24 weeks post-treatment, including the Numerical Rating Scale for PSES, arm function, and quality of life.

Main Results:

• Efficacy determined by the proportion of participants achieving a meaningful improvement (18%) in the 7-day NRS-S for PSES.
• Comparison of improvement rates between SHAPES, TENS, and standard care groups.
• Assessment of secondary outcomes including arm motor function and quality of life, alongside a health economic evaluation.

Conclusions:

• The SHAPES trial will provide crucial data to inform the management of post-stroke elbow spasticity.
• SHAPES presents a potentially low-cost, self-administered, and repeatable intervention for spasticity management.
• The study will offer essential evidence on the efficacy of TENS for spasticity, addressing a gap in current clinical practice.