Walk Best with MS: Integrating the ‘Heel-2-Toe’ sensor with physiotherapy training for improving walking quality in people with MS

Studies

Study Title: Walk Best with MS: Integrating the ‘Heel-2-Toe’ sensor with physiotherapy training for improving walking quality in people with MS
Rationale: Improving gait quality should be a primary target of therapy for people with MS, however the emphasis up until now has been on improving gait speed.
Study Description: The purpose of this study is to identify aspects of feasibility related to use of a wearable device (Heel2Toe) designed to improve walking quality, where feasibility refers to adherence to the protocol, ease of use, and potential to change gait quality and walking behaviours.

The specific research objective is to estimate the extent to which measures of walking capacity, gait quality and walking behaviours change after 3 months of gait training in two groups of people, one group training with the Heel2Toe sensor and one group training without the sensor (using PT prescribed exercises and a workbook only). A secondary objective is the extent to which values on fatigue, cognition, mood, and motivation co-evolve gait-related outcome.

The study runs over a 24-week period, with four research assessment time point (baseline, mid-intervention, post-intervention, follow-up) and includes a 12-week training intervention. After the first assessment participants are randomized (like flipping a coin) into either the ‘intervention’ or ‘control’ group. We use a computer to randomize participants to one of the study groups. It means that the researchers will not choose, and participants cannot choose which study group they are in. Participants will be put into a group by chance. Participants in both groups will get an individualized physiotherapy program, and if in the ‘intervention group’, participants will also get to use the ‘Heel-2-Toe’ sensor as part of their training program. If randomized to the ‘control’ group, participants will have the option to still use the ‘Heel – 2- Toe’ sensor at the end of the study if they’d like. The physiotherapy training intervention lasts 12 weeks and it is made up of 2 parts:

- The first 2 weeks will have in-person sessions with study physiotherapist (3 x 45 min sessions per week) at the School of Rehabilitation Science, University of Saskatchewan, and
- The remaining 10 weeks, participants will be asked to do their training program at home and will have a 1 x 30 min virtual session per week with their physiotherapist to check in, answer any questions, and help modify your training program as appropriate.
Starting Date: 2024-01-01
Ending Date: 2024-12-31
Who can participate: Adults (over age 18 years) with some walking changes from their MS
Trial Institution: University of Saskatchewan
Trial Investigator: Sarah Donkers
Contact Information: Sarah Donkers sarah.donkers@usask.ca
Trial Funding: College of Medicine