Combining specific task-oriented training with manual therapy to improve balance and mobility in patients after stroke: a mixed methods pilot randomised controlled trial.

Abstract

In absence of existing studies, to describe changes in balance and mobility, following specific task-oriented training (TOT), its combination with talocrural manual therapy (MT-TOT) or no intervention, in chronic stroke patients. To explore the feasibility of a full-scale randomised controlled trial (RCT) based on criteria of recruitment, retention and adherence rates, adverse events, falls and acceptability of the intervention. Using an assessor-blinded pilot RCT, 36 stroke patients were allocated to either MT-TOT, TOT, or controls. Supervised interventions were performed 45 min, 2×/weekly, for 4 weeks, and home-based practice 20 min, 4x/weekly for 4 weeks. Qualitative interviews evaluated intervention acceptability. Outcomes of balance, mobility, ankle dorsiflexion range of motion (ROM), falls and health-related quality of life (HRQoL) were assessed at baseline, post-intervention and 4-week follow-up. Preliminary efficacy of MT-TOT and TOT was shown in improving balance (effect size 0.714), walking speed (0.683), mobility (0.265), dual-tasking mobility (0.595), falls (0.037), active and passive talocrural ROM (0.603; 0.751) and activities and social participation related HRQoL domains (0.332-0.784) in stroke patients. The feasibility of a larger RCT was confirmed. Specific MT-TOT and TOT appeared effective and are feasible in stroke patients. A larger RCT is needed to validate the results.<b>Trial Registration:</b> German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.