The LOTUS Study
Aim(s):
This two-part study aims to explore feasibility, acceptability and potential effectiveness of dynamic lycra orthoses as an adjunct to upper limb rehabilitation after stroke to inform the design of a definitive randomised control trial. Phase one is a qualitative evaluation of stroke survivors’, staff and carers experiences of using the dynamic lycra orthoses as an adjunct to usual practice. Phase two is a feasibility randomised controlled trial to explore the feasibility and to provide estimated effect sizes to inform a definitive trial.
Summary:
Phase one is complete and phase two is ongoing. For Phase 1, Stroke survivors (n=17), with persistent upper limb activity limitation, 2-4 weeks after stroke, were purposively sampled by the severity of activity limitation to wear tailor-made dynamic lycra orthoses gauntlets, involving thumb, wrist and elbow, for eight hours per day for eight weeks. Individual semi-structured interviews after lycra orthoses wear explored experiences of wear and perceived benefits.
Analysis using the framework approach showed most participants could put on the lycra orthoses with ease and adapted patterns of wear to their needs and perceptions of usefulness. Control of movement, task performance, jerkiness and muscle tightness were perceived benefits, as was greater sensory awareness of the limb. However, six more severely affected participants discontinued wear due to onset of upper limb swelling. Findings informed the development of the intervention and selection of outcome measures for the feasibility trial. To date, 33 stroke survivors have been recruited to the feasibility trial, of a target of 51. Completion date is the 31st March 2018.
Principal Investigator: Professor Jacqui Morris
External collaborators: Crighton G - NHS Tayside, Donnan P - University of Dundee, Kroll T - University of Dundee, Mendes R - NHS Tayside, Wedderburn L - NHS Tayside
Funder: Chief Scientist Office