Protocol for a home-based self-delivered prehabilitation intervention to proactively reduce fall risk in older adults: a pilot randomized controlled trial of transcranial direct current stimulation and motor imagery.
Clayton W Swanson, Sarah E Vial, Todd M Manini, Kimberly T Sibille, David J Clark
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引用次数: 0
Abstract
Background: Several changes occur in the central nervous system with increasing age that contribute toward declines in mobility. Neurorehabilitation has proven effective in improving motor function though achieving sustained behavioral and neuroplastic adaptations is more challenging. While effective, rehabilitation usually follows adverse health outcomes, such as injurious falls. This reactive intervention approach may be less beneficial than prevention interventions. Therefore, we propose the development of a prehabilitation intervention approach to address mobility problems before they lead to adverse health outcomes. This protocol article describes a pilot study to examine the feasibility and acceptability of a home-based, self-delivered prehabilitation intervention that combines motor imagery (mentally rehearsing motor actions without physical movement) and neuromodulation (transcranial direct current stimulation, tDCS; to the frontal lobes). A secondary objective is to examine preliminary evidence of improved mobility following the intervention.
Methods: This pilot study has a double-blind randomized controlled design. Thirty-four participants aged 70-95 who self-report having experienced a fall within the prior 12 months or have a fear of falling will be recruited. Participants will be randomly assigned to either an active or sham tDCS group for the combined tDCS and motor imagery intervention. The intervention will include six 40-min sessions delivered every other day. Participants will simultaneously practice the motor imagery tasks while receiving tDCS. Those individuals assigned to the active group will receive 20 min of 2.0-mA direct current to frontal lobes, while those in the sham group will receive 30 s of stimulation to the frontal lobes. The motor imagery practice includes six instructional videos presenting different mobility tasks related to activities of daily living. Prior to and following the intervention, participants will undergo laboratory-based mobility and cognitive assessments, questionnaires, and free-living activity monitoring.
Discussion: Previous studies report that home-based, self-delivered tDCS is safe and feasible for various populations, including neurotypical older adults. Additionally, research indicates that motor imagery practice can augment motor learning and performance. By assessing the feasibility (specifically, screening rate (per month), recruitment rate (per month), randomization (screen eligible who enroll), retention rate, and compliance (percent of completed intervention sessions)) and acceptability of the home-based motor imagery and tDCS intervention, this study aims to provide preliminary data for planning larger studies.
Trial registration: This study is registered on ClinicalTrials.gov (NCT05583578). Registered October 13, 2022. https://www.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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