Effect of WalkingTall with smart socks on gait stability in people with Parkinson's disease

Following baseline assessments at Neuroscience Research Australia (NeuRA) all participants in this single-arm study will receive 2 home visits 1-week apart. Each home visit will include a 60-minute supervised training session (including breaks) on how to use the balance, step training and interval walking apps for the neuro-rehabilitation intervention. Supervision is provided by a trained researcher, with a background in physiotherapy, exercise physiology or eHealth exercise interventions (called "the trainer"). After each supervised home rehabilitation session, participants will be instructed to do the prescribed neuro-rehabilitation exercises for at least 20-minutes each day, on at least 4 of the subsequent 6-days, unsupervised in their home environment. After two weeks participants will be reassessed at NeuRA. The primary outcome is improved gait stability as measured by step-time variability during straight line walking while "on" medication. Rehabilitation exercise prescription and intensity is based on each participant's baseline balance, stepping and walking ability, which is assessed by the trainer using the balance, step training and interval walking apps. Session adherence is monitored both by the apps, which report to a central remote database, and through diaries to provide additional adherence details. (1) The balance training uses a tablet app (called StandingTall that has been validated in older people at NeuRA). StandingTall has a selection of 2000 exercises (including standing, transferring, walking, stepping and box). Baseline balance ability is determined through series of standing balance exercises administered by the app's internal algorithms with supervision from the trainer. Exercises include heel raises, postural transitions, reaching and stepping in different directions. Props used include chairs, a foam block and wooden stepping box. Each exercise is repeated 3 times and lasts between 15 seconds and 45 seconds depending on the exercise. The exact number of exercises completed depends on the exact duration of each exercise selected and therefore how many can be completed by the participant in a 20 minute session. (2) The step training is a component of the WalkingTall with PD app (created specifically for this study and developed at NeuRA). Step training uses a smartphone and currently comprises 5 exercises (high knees, forward, backward, side and figure 8 stepping) with and without support from chairs or arm swings depending on participant ability. Stepping cadence is set by the smart sock stimulation duty cycle and rhythmic auditory cues using the stepping app. Props used include smart socks, a colored stepping mat and two chairs for lateral support as required. Exercise intensity is controlled by stepping cadence. Baseline stepping cadence is set by the trainer with feedback from the participant. Baseline stepping cadence is fine tuned to during the second home-based supervised session based on selecting a cadence similar to the participants usual self-selected walking cadence that maximizes the participant's perceived stepping stability on a scale of 0% to 100% with 100% being most stable. The duration of each stepping exercise repetition is 30 seconds. The 10 minutes of step training comprises 20 by 30 second stepping exercises. Prescribed cadences comprise baseline (100%), slow (80%) and fast (120%). (3) The interval walking app is a component of the WalkingTall with PD app (created specifically for this study and developed at NeuRA) Interval walking also uses the smartphone. Participants are required to complete 10 minutes of walking comprising 5-by-2 minute walks at the same baseline, slow and fast cadences as prescribed by the trainer for the stepping exercises above. Exercise intensity is controlled by walking cadence. Walking cadence is also set by the smart sock stimulation duty cycle and rhythmic auditory cues using the walking app. Baseline assessments, week 0: The participant will come to NeuRA for baseline assessments. This will take up to 3 hours including breaks. Home visit 1, week 1: The trainer will visit the participant in their home. Participants will be instructed how to use the balance training app by the trainer. This will take up to 60-minutes (20-minutes of training and up to 40-minutes of breaks) using the StandingTall tablet app [Delbaere 2018]. Participants will place the tablet on a music stand in front of them. Exercises will be conducted on a flat surface, with a stepping box and foam block used as props. Each session comprises a selection of balance and stepping exercises selected by the training algorithm (from a pool of over 2000 exercises). During the initial home visit, the trainer will set the baseline difficulty level and exercise types to ensure the participant can complete the sessions prescribed by the exercise app properly and safely. Participants will then be instructed to complete at least 4 by 20-minute training sessions of the StandingTall app in their home environment over the next 6-days. Home visit 2, week 2: The trainer will visit the participant in their own home. The trainer will pick up the balance training equipment and conduct structured interview and usability questionnaires to obtain end-user feedback about the balance intervention. The trainer will then provide the participant with new equipment required for the smart sock components of this intervention and undertake the first step and walk training with the participant in their home environment. Step training up to 30-minutes (10-minutes of training and up to 20-minutes of breaks) will use smart socks fitted with haptic motors capable of stimulating the peripheral nerves of the feet synchronously with the target the target stepping cadence. The target stepping cadence will progress from slow (20% below preferred cadence) normal (preferred cadence) and fast (20% above preferred cadence) with guidance from the trainer. A combination of haptic, auditory and visual (step mat) stimulation will be used according to participants preferences. Step training will use the step mat with colored targets that facilitate short and long steps in different directions, stepping on the spot with high knees and turning. Step training using the phone app will be demonstrated by the trainer and progress from simple to complex sequences. The prescription of stepping exercises will be based on participant's ability to complete each stepping exercise safely and properly as assessed by the trainer. Participants will repeat each prescribed sequence/cadence combination until a stable stepping rhythm is achieved. Interval walk training up to 30-minutes (10-minutes of training and up to 20-minutes of breaks) will use smart socks fitted with haptic motors capable of stimulating the peripheral nerves of the feet synchronously with the target the target walking cadence. The target stepping cadence will progress from slow (20% below preferred cadence) normal (100% of preferred cadence) and fast (20% above preferred cadence) with guidance from the trainer. The trainer will guide the participant to select an appropriate walking course over flat ground and free from obstacles. The walking course and target step lengths will be selected by the trainer based on the participant's baseline walking ability to ensure the participant can safely complete the training walks. Participant's will use the phone app to undertake interval walking. The phone app monitors the participants's gait in real time, provides automated verbal encouragement during the walk, controls the smart socks stimulation and duration of each interval walk. Participants will then be instructed to complete at least 4 by 10-minute step training sessions and 4 by 10-minute walk training sessions in their home environment over the next 6-days. Followup assessments, week 3: Participants will bring the training equipment back to NeuRA, provide feedback about the stepping and walking interventions and undergo reassessment. This will take up to 3 hours including breaks.