Determining the optimal volume of reactive balance training after stroke: a pilot randomized controlled trial
- 1University Health Network
Abstract
BackgroundOur long-term goal is to determine the optimal volume of reactive balance training (RBT) in people with sub-acute stroke. This study aims to inform the design of a larger trial to address this long-term goal.
Trial designAssessor-blinded three-arm pilot randomized controlled trial.
MethodsParticipants (n=36) with sub-acute stroke were randomly allocated to one of three groups: 1, 3, or 6 RBT sessions. All sessions were delivered over 2-3 weeks. Feasibility outcomes included recruitment and retention rates, intervention fidelity and adherence, and completeness of outcome assessments. Participants reported falls and physical activity for 6 months post-training; falls data were used to estimate sample size for a future trial. Functional balance, balance confidence, and balance reactions were assessed at: 1) study enrolment; 2) post-training; and 3) 6 months post-training to estimate effect sizes for a future trial.
ResultsThirty-five participants initiated training and 34 contributed post-training assessment data. Intervention adherence was high: participants completed 1.0, 2.9, and 5.7 RBT sessions on average in the 1-, 3- and 6-session, respectively. Functional and questionnaire outcomes were [≥]80% complete at most time points, although follow-up questionnaires at 2 and 4 months met only 74% completeness. Falls monitoring data were available for 30 participants, with 15 falls reported. Estimated sample sizes for a definitive trial using falls as the primary outcome (n=408-782) were not feasible for a single site; alternative primary outcomes (stability following balance perturbations) produced more feasible sample size estimates (n=30-72). Minor adverse events were reported by 1, 2, and 6 participants in the 1-, 3- and 6-session groups, respectively.
ConclusionsThe modified intervention and assessment procedures were feasible; however, a definitive single-site trial using falls as the primary outcome is not feasible. Stability-based outcomes may support a more feasible future trial.
Trial registrationclinicaltrials.gov, NCT04219696
Related
- Moderate-intensity exercise versus high-intensity interval training to determine the optimal training intensity for walking rehabilitation in chronic stroke (HIT-Stroke Trial 2): a study protocol for a randomized controlled trial
- Multicomponent training versus elastic-band training for improving global cognition and executive function in older women: a randomized controlled trial
- Comparative effects of supervised aerobic and combined training with dietary counseling on metabolic biomarkers in sedentary adult male bank employees: a randomized controlled trial
- EFFECT OF DIFFERENT BALANCE TRAINING PROGRAMS ON POSTURAL CONTROL IN CHRONIC ANKLE INSTABILITY: A RANDOMIZED CONTROLLED TRIAL
- Elastic Band Training Across Competitive Levels in Female Soccer: A Randomized Controlled Trial With Follow-up
BibTeX
@misc{mansfield2026determining,
title = {{Determining the optimal volume of reactive balance training after stroke: a pilot randomized controlled trial}},
author = {A. Mansfield and D. Jagroop and C. J. Danells and T. Bhatt and E. L. Inness},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.02.26362056},
url = {https://www.medrxiv.org/content/10.64898/2026.09.02.26362056v1},
note = {CC BY-NC},
}
RIS
TY - UNPB
TI - Determining the optimal volume of reactive balance training after stroke: a pilot randomized controlled trial
AU - A. Mansfield
AU - D. Jagroop
AU - C. J. Danells
AU - T. Bhatt
AU - E. L. Inness
PY - 2026
DA - 2026/09/02
PB - medRxiv
DO - 10.64898/2026.09.02.26362056
UR - https://www.medrxiv.org/content/10.64898/2026.09.02.26362056v1
AB - BackgroundOur long-term goal is to determine the optimal volume of reactive balance training (RBT) in people with sub-acute stroke. This study aims to inform the design of a larger trial to address this long-term goal. Trial designAssessor-blinded three-arm pilot randomized controlled trial. MethodsParticipants (n=36) with sub-acute stroke were randomly allocated to one of three groups: 1, 3, or 6 RBT sessions. All sessions were delivered over 2-3 weeks. Feasibility outcomes included recruitment and retention rates, intervention fidelity and adherence, and completeness of outcome assessments. Participants reported falls and physical activity for 6 months post-training; falls data were used to estimate sample size for a future trial. Functional balance, balance confidence, and balance reactions were assessed at: 1) study enrolment; 2) post-training; and 3) 6 months post-training to estimate effect sizes for a future trial. ResultsThirty-five participants initiated training and 34 contributed post-training assessment data. Intervention adherence was high: participants completed 1.0, 2.9, and 5.7 RBT sessions on average in the 1-, 3- and 6-session, respectively. Functional and questionnaire outcomes were [≥]80% complete at most time points, although follow-up questionnaires at 2 and 4 months met only 74% completeness. Falls monitoring data were available for 30 participants, with 15 falls reported. Estimated sample sizes for a definitive trial using falls as the primary outcome (n=408-782) were not feasible for a single site; alternative primary outcomes (stability following balance perturbations) produced more feasible sample size estimates (n=30-72). Minor adverse events were reported by 1, 2, and 6 participants in the 1-, 3- and 6-session groups, respectively. ConclusionsThe modified intervention and assessment procedures were feasible; however, a definitive single-site trial using falls as the primary outcome is not feasible. Stability-based outcomes may support a more feasible future trial. Trial registrationclinicaltrials.gov, NCT04219696
ER -