Title: Development and initial evaluation of the efficacy of afferent reawakening treatment of the foot on lower limb function after stroke: A feasibility study in preparation for the START OFF trial.
Funder: Health Education England

Abstract: Background Walking is a priority for stroke survivors, necessitating dealing with challenging deficits; motor, sensory, visual, or cognitive. Physiotherapy to address balance and gait post-stroke was identified within the top ten research priorities for stroke in Scotland (James Lind Alliance, Pollock et al 2012). Sensory loss occurs in up to 60% of people post-stroke (Winward et al 1999), and is associated with lower Barthel scores ( 60), when controlling for motor impairment (Patel et al 2000). Experimental findings show afferent input from the sole of the foot is important for balance (Kavounoudias et al 1999, Maurer et al 2001, Meyer et al 2004, Horak et al 1990). Minor somatosensory loss in the foot in healthy individuals affects postural sway, which cannot be compensated for by visual or vestibular systems (Wang and Lin 2008). Therapy known as Mobilization and Tactile Stimulation (MTS) provides sensory stimulation which, when applied to the paretic upper limb and hand (UL), enhances post-stroke recovery (Hunter et al 2008, Winter et al 2013). MTS is also commonly used in clinical practice to stimulate the lower limb and foot (LL) post-stroke. However, this is an area where research evidence is sparse. The aim of this proposed research is to develop two sensory stimulation intervention protocols for the LL to enhance recovery of balance, walking and functional ability. Evaluation of the protocols will then be undertaken in a feasibility trial, providing information for design of a main trial, subsequent to this PhD, the results of which will be relevant for clinical practice. Design A mixed methods design will involve: 1) development of two sensory stimulation protocols, working iteratively with stroke survivors and clinical therapists: a) MTS to the paretic LL; and b) Wearing textured insoles (TI) providing afferent input to the sole of the foot. Both protocols will be combined with 30 minutes of task-specific gait training (TSGT) and practice, chosen because level 1a evidence has demonstrated its effectiveness post stroke (Foley et al 2013); 2) a feasibility trial: all participants will undertake baseline measurements and then be randomised to either MTS+TSGT or TI+TSGT. Twenty sessions of intervention for the LL is considered to be an adequate dose, building in some contingency, since 14 sessions were effective for the UL (Hunter et al 2011). Outcomes will be measured once a week during the intervention, then on completion of intervention, and at follow-up one month later. Participants will be encouraged to keep a daily diary and invited to attend a focus group on completion of intervention, to help gain a deeper insight into perceived changes in functional ability and experiences of participating in this research, including intervention acceptability. Future Developments The results of this trial will determine whether a subsequent fully-powered main trial is feasible, informing any necessary modifications and providing information about: recruitment and attrition rates; sample size estimation; practicality of recruitment strategy; acceptability of treatment protocols; and variance in clinical efficacy. This subsequent main trial will potentially inform clinical practice, via guidelines and, if intervention is found to be effective, there is potential to influence rehabilitation strategies, improving outcomes for stroke survivors in the future. Targeting evidence based interventions will also save money, because resources can be directed at delivering effective interventions. Abbreviations used in application: ADL Activities of daily livingLL - Lower limb and foot MRC - Medical Research Council MTS Mobilization and tactile stimulation OMs Outcome measures PPI Patient and Public Involvement RCT - Randomised controlled trial TI Textured insoles TSGT Task specific gait training UK United Kingdom UL - Upper limb and hand

Lay abstract: Walking can be difficult after stroke, especially if there is a change in the sense of feeling (sensation) of the foot. A treatment to the upper limb involving stretching, mobilising and stimulating the skin and joints has been shown to be effective. This will be developed and applied to the foot and ankle, involving stroke survivors, seven to sixteen weeks post stroke. This treatment will be compared to wearing a textured insole. Treatment will involve twenty sessions, and measures will be taken, related to feeling, movement, balance and walking. Focus groups will explore participants' changes in domestic and social activity.

Research activity codes: 6.3 MEDICAL DEVICES;6.7 PHYSICAL
Health categories: STROKE