MoTaStim-Foot, a Randomized, Single-Blinded, Mixed-Methods, Feasibility Study Exploring Sensory Stimulation of the Foot and Ankle Early Poststroke

Aries, Alison M.; Pomeroy, Valerie M.; Sim, Julius; Read, Sue; Hunter, Susan M.

Abstract

Introduction: It is not known whether increasing somatosensation of the foot could improve walking recovery after stroke. This study was undertaken to investigate the feasibility of conducting a future randomized controlled trial (RCT) to determine whether the effect of task-specific gait training is enhanced more with mobilization and tactile stimulation or by wearing textured insoles. The objectives of the present feasibility study were to (1) explore recruitment methods and monitor attrition; (2) explore acceptability of interventions; (3) investigate feasibility, cost, and acceptability of a battery of outcome measures; (4) explore responses to intervention over time informing future dose; (5) investigate suitability of daily diaries and focus groups for exploring stroke survivors’ experiences; and (6) generate participant information, that is, demographics, clinical characteristics, including time since stroke, type of stroke, and comorbidities.
Methods:Design: Randomized, single-blinded, mixed-methods feasibility study. Setting: Rehabilitation ward and community. Participants: Thirty-four people aged 18+ years, 42 to 112 days poststroke who provided informed consent (IRAS No.: 171968/REC Ref 16/WM/0080). Intervention: Participants were randomly allocated to either 30 to 60 minutes mobilization and tactile stimulation or unlimited textured insole wearing. All participants also received 20 sessions of task-specific gait training over the 6-week intervention phase. Outcomes: Lower limb sensorimotor impairment was measured before randomization, after the 6-week intervention phase, and 1 month thereafter (follow-up). Adherence to the allocated intervention and the number/length of sessions were documented. Participants recorded their trial experiences during the intervention period in daily diaries and participated in focus groups exploring acceptability of interventions and overall trial experience, on completion of interventions (Objective 2). Analysis: Recruitment, attrition, and adherence rates (Objective 1) were calculated with descriptive statistics. The magnitude and variance of within-group changes in potential outcome measures (Objectives 3 and 4) were calculated. Thematic analysis of the diaries and focus groups was undertaken (Objectives 2 and 5).
Results: Thirty-four stroke survivors were recruited. Recruitment, attrition, and adherence rates were 48.8%, 5.9%, and 97.9%, respectively, on trial completion (Objective 1). The magnitude of within-group change was statistically significant for both groups for the 5-m walk test, Functional Ambulation Classification, modified Rivermead Mobility Index, and the Lower Extremity Motricity Index (P < .01) (Objective 4). Participants described diaries as “simple” and “valuable” (Objective 5). Quotations from the focus groups indicated acceptability and that the trial experience was positive, for example: “It [the trial] was no trouble at all” and “the treatment’s given me the ability to walk.”
Conclusion: Feasibility of delivering and acceptability of the interventions and outcome measures was established. The results indicate that a subsequent RCT of mobilization and tactile stimulation + task-specific gait training and wearing of textured insoles + task-specific gait training is feasible. The variance of the outcome measures will inform the sample size calculation for a subsequent RCT.

Citation

Aries, A. M., Pomeroy, V. M., Sim, J., Read, S., & Hunter, S. M. (2018, November). MoTaStim-Foot, a Randomized, Single-Blinded, Mixed-Methods, Feasibility Study Exploring Sensory Stimulation of the Foot and Ankle Early Poststroke. Presented at 2018 American Society of Neurorehabilitation Annual Meeting, San Diego, CA. United States

• Presentation Conference Type: Speech
• Conference Name: 2018 American Society of Neurorehabilitation Annual Meeting
• Conference Location: San Diego, CA. United States
• Start Date: Nov 1, 2018
• End Date: Nov 2, 2018
• Deposit Date: Jun 5, 2023
• Publisher: SAGE Publications
• Publisher URL: https://journals.sagepub.com/doi/10.1177/1545968318817151