Dynamic Elastomeric Fabric Orthoses (DEFO) and physiotherapy after Botulinum toxin (BT) in adults with focal spasticity: A feasibility study using mixed methods.

Abstract

Acknowledgements: DM Orthotics Ltd©Title: Dynamic Elastomeric Fabric Orthoses (DEFO) And Physiotherapy After Botulinum toxin (BT) In Adults With Spasticity: A Feasibility Study Using Mixed Methods. Aim: A study to investigate the potential feasibility (including estimated effect-size), acceptability and health benefits of DEFO and physiotherapy in treatment of spasticity following intramuscular injection of BT. Participants: Adults living in the community with focal spasticity of the upper or lower limb (Modified Ashworth Scale 2-3) recruited at a regional Spasticity Clinic. Intervention: provision of an individually fitted DEFO (worn daily up to 8 hours) usual care and physiotherapy (as required) for 6 weeks. Methods: Mixed methods embedded design feasibility study: Quantitative: Feasibility single-blind RCT: Intervention Group: DEFO intervention protocol, usual care and physiotherapy, Control Group: usual care and physiotherapy. Qualitative: Topic guided interviews of the intervention group and clinicians. Measures: Goal Attainment Scale (GAS) primary measure and secondary measures for function and care benefit; Arm Activity measure (ArmA), Leeds Arm Impact Score (LASIS), VAS for pain, European Quality of Life-5 Dimensions (EQ-5D), gait velocity (10MTT). Variance and fidelity was captured with: DEFO wearing record, Activity Log, clinical records and Physiotherapy modalities. Analysis: ANCOVA adjusted means and statistical comparison for significance of measures (at baseline, after six weeks and twelve weeks) between groups and to inform power calculations. Thematic Analysis of clinician and participant transcribed interviews. Quantitative and qualitative findings were integrated and triangulated to inform a larger study. Results: Participants (n=25) recruited over twelve months, (n=22) completed study. Statistical analysis showed improvements in both groups with greater health benefit in the intervention group with mean difference in the GAS of 12.17 (95%CI: 3.16 to 21.18; p = 0.014) but no statistical significance in the secondary measures. Effect-size was estimated from the GAS findings for 200 per group for a larger study. Physiotherapy modalities for spasticity were linked to ‘passive’ and ‘active’ function. Feasibility and acceptability was established with Thematic Analysis providing valuable insight into patient and clinician perspectives on disability. Conclusions: Findings indicated potential added health benefits including carer benefit. Feasibility, acceptability and clinical application of DEFO as a potential new intervention were established. This has implications for future spasticity management with patient benefit for passive and active function. Further research is indicated with a fully powered study (based on the GAS sample results) to evaluate DEFO efficacy in people with spasticity following BT. Key words: Spasticity, Botulinum toxin, physiotherapy, dynamic orthoses.Registered with local NHS R&D and Exeter University