Real-time auditory feedback for improving gait and walking ability in people with Parkinson's Disease: a pilot and feasibility study

Background Technology is poised to bridge the gap between demand for therapies to improve gait in people with Parkinsons and available resources. A wearable sensor, Heel2ToeTM, a small device that attaches to the side of the shoe and gives a sound each time the person starts their step with a strong heel strike has been developed and pre-tested by a team. The objective of this study was to estimate feasibility and efficacy potential of the Heel2ToeTM sensor in changing walking capacity and gait pattern in people with Parkinsons. Methods A pilot study was carried out involving 27 people with Parkinsons randomized 2 to 1 to train with the Heel2Toe[TM] sensor and or to train with recommendations from a gait-related workbook. Results A total of 21 completed the 3-month evaluation, 14 trained with the Heel2ToeTM sensor and 7 trained with the workbook. Thirteen of 14 people in the Heel2Toe group improved over measurement error on the primary outcome, the Six Minute Walk Test, (mean change 66.4 m.) and 0 of the 7 in the Workbook group (mean change -19.4 m.) 4 of 14 in the Heel2Toe group made reliable change and 0 of 7 in the Workbook group. Improvements in walking distance were accompanied by improvements in gait quality. 40% of participants in the intervention group were strongly satisfied with their technology experience and an additional 37% were satisfied. Conclusions Despite some technological difficulties, feasibility and efficacy potential of the Heel2Toe sensor in improving gait in people with Parkinsons was supported. ### Competing Interest Statement NEM discloses relationship with PhysioBiometrics Inc. for this work. KKVM discloses relationship with PhysioBiometrics Inc. for this work. EH discloses relationship with PhysioBiometrics Inc. for this work. HD discloses relationship with PhysioBiometrics Inc. for this work. AAS discloses relationship with PhysioBiometrics Inc. for this work. ### Clinical Trial NCT04300348 ### Funding Statement Healthy Brains for Healthy Lives ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The project was approved by the Research Ethics Board of the McGill University Health Center on Feb 17, 020 (File # 2020-5842). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Pilot data only not available