Abstract
AbstractBackgroundTechnology is poised to bridge the gap between demand for therapies to improve gait in people with Parkinson’s 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 at McGill University. The objective of this study was to estimate feasibility and efficacy potential of the Heel2ToeTMsensor in changing walking capacity and gait pattern in people with Parkinson’s.MethodsA pilot study was carried out involving 27 people with Parkinson’s randomized 2:1 to train with the Heel2Toe[TM] sensor and or to train with recommendations from a gait-related workbook.ResultsA total of 21 completed the 3-month evaluation, 14 trained with the Heel2Toe[TM] 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.ConclusionsDespite some technological difficulties, feasibility and efficacy potential of the Heel2Toe sensor in improving gait in people with Parkinson’s was supported.Key messages regarding feasibility1)What uncertainties existed regarding the feasibility?The Heel2Toe sensor had been used in clinical research as an assessment tool and in two small proof-of-concept studies with short-term supervised use to detect change and get user feedback on their experience. There was a need to test the sensor for home use and include a control group as perhaps the attention and exercise recommendations could alone have benefit. Therefore, we designed this pilot and feasibility study.2)What are the key feasibility findings?Dropouts from the trial were mainly related to the COVID situation. There were no adverse events in either group. Challenges with using the Heel2Toe sensor related to functionality of the app which were addressed immediately; hardware challenges were addressed in revisions including ease of charging and Bluetooth connectivity; there were challenges for people to use the smart-phone app optimally. Our current revision has removed need for the smartphone. The results also showed that people were able to use the sensor on their own at home with some technical support (average 22 minutes per person) which diminished over time and that, despite technical challenges, the majority of people were satisfied with their experience with the technology, some very much so. There was a strong response in the Heel2Toe group and a near nil response in the control group demonstrating efficacy potential.3)What are the implications of the feasibility findings for the design of the main study?The main study will use the revised version of the Heel2Toe sensor which has eliminated the challenges with connectivity and smartphone skills. Using the 6MWT as the outcome and based on conservative estimates of effect size (0.5), a sample size of 64 per group would be supported. This sample size would also be sufficient for estimating effects on other explanatory and downstream outcomes. Participants would keep the sensor after the study.
Publisher
Cold Spring Harbor Laboratory