A Phase II Randomised Controlled Trial Comparing Home-based Self-managed Rehabilitation Program Using eHealth Technologies (Called WalkingTall-PD) With a Low-intensity Exercise Program (Called Mobility-plus).

WalkingTall-PD is designed to rehabilitate gait and balance in a minimum of 6-weeks (program progression and total duration is based on sessions completed). It uses affordable eHealth technologies (tablet, phone, smart socks or leg bands, depending on participant preference, with vibration motors, step mat and earbuds). Specific to Parkinson's disease (PD), it uses rhythmic cues to address excessive step-time variability, balance impairments and freezing of gait (FOG) (Henderson et al., 2017; Allen et al., 2013). The key aspect of this intervention is the stimulation provided by the smart socks/leg bands that vibrate. The stimulus duty cycle is synchronised with the participants walking gait to entrain neuromuscular signals and enhance sensorimotor integration. This results in an immediate improvement in motor control during gait, reduced movement variability and increased walking ability. The integration of our eHealth tools with home visits and telehealth appointments into a continuous user experience is another major strength of our program. Each component is introduced during 1:1 home visits and/or telehealth appointments to ensure standardization of the clinical trial and maximize the safety of participants. The home visits and/or telehealth appointments will be conducted by a trainer (physiotherapist or exercise physiologist with experience in working with people with PD).

WalkingTall-PD meets the urgent need for an effective, affordable and scalable self-managed eHealth solution for people with PD. It includes an evidence-based program to enhance independence and prevent falls. The scientific rationale and eHealth technology underpinning WalkingTall-PD are well tested. Our team has demonstrated that home-based approaches have high acceptability and adherence rates, shown that balance training can reduce fall-risk and that external cues can reduce step-time variability in people with PD. Participants may use their preferred devices (or devices we supply) to access WalkingTall-PD, which will be available across platforms. Components are introduced during 1:1 home visits and telehealth appointments by a trainer. Delivery is then unsupervised using self-management principles, with ongoing remote monitoring a web-based central monitoring platform and database back-end.Participants will be informed that WalkingTall-PD is a supplementary program and does not replace usual care. The WalkingTall-PD program comprises the following components:

(i) Balance training is introduced in the week-one home visit or telehealth appointment by the trainer using the WalkingTall smart phone app. Baseline balance ability is determined by completing a series of balance exercises using the app with supervision from the trainer. For participants who choose the telehealth option, the primary device (smart phone) will provide the training program while a secondary device (iPad) will be used for patient safety monitoring and telehealth consultation. Exercises include heel raises, postural transitions, reaching and stepping in different directions and holding poses that challenge balance. Props used include a mobile stand (primary device), a tablet stand for the secondary device, non-slip balance mat and chairs for support. Balance training starts with simple movement sequences and progresses to more challenging balance poses based on participant feedback. Movements during balance training are guided by the combination of haptic cues provided by the smart socks, insoles or ankle bands(with the choice of smart garment based on participant preference), auditory cues by the phone app and visual cues by the balance/stepping mat. Participants will be encouraged to complete 5 by 10-minutes balance training sessions/week. Participants who choose the telehealth option will be provided with a home visit if they have difficulty with the balance training.

(ii) Walk training (in a safe environment) is introduced in the second home visit or telehealth appointment (no sooner than week-3) by the trainer using our WalkingTall phone app. Participant-adjustable rhythmic cues (Brodie et al., 2015) auditory, visual and haptic cues are used to reduce gait variability during gait training. Participants are instructed how to select an appropriate walking course (clear of trip hazards and with appropriate rest areas), target cadence and training/rest duration by the trainer. The walking course will be approved by the trainers, either in person or remotely via video recording if the participant chooses the telehealth option. For participants included in the telehealth option, if the trainer has concerns about the selected walking track, a home visit will be provided to fix any safety issues. Each session, consists of 5 by 2-minutes walks with 30-seconds rest between each walk. Rhythmic auditory cues (self-selected metronome) are provided by the phone app and earbuds can be used for discretion. Rhythmic haptic cues are provided by the smart socks, insoles or smart ankle bands, with the choice of smart garment based on participant preference. Participant-specific visual cues may also be used, if required, such as parallel lines fixed perpendicular to the walking track to step over. Participants will be instructed to use their normal walking aids as appropriate. Participants will be encouraged to complete 5 by 10-minute walk training in addition to the 5 by 10-minute balance training sessions each week. Participants who choose the telehealth option will be provided with a home visit if they have difficulty with the walk training.

(iii) Step training is introduced in the third home visit or telehealth appointment (no sooner than week-5) by the trainer using the WalkingTall phone app. Visual, auditory and haptic cues are synchronized with the movement to retrain impaired stepping (Caetano et al., 2018), turning, balance (Allen et al., 2013) and strength in people with PD. Auditory stepping cues are provided by the phone app using a metronome beat. Visual cues are provided by the non-slip stepping mat. Haptic stepping cues are provided by small vibrators. Participants will be encouraged to complete 5 by 10-minute step/strength training, 5 by 10-minute walk training and 5 by 10-minute balance training sessions each week. In week-5 the trainer will also introduce walk training in more complex environments or walking as part of normal daily-life activities as appropriate. Participants who choose the telehealth option will be provided with a home visit if they have difficulty with the step and training.