Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001272189
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
16/09/2019
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of WalkingTall with smart socks on gait stability in people with Parkinson's disease
Scientific title
WalkingTall with Parkinson's disease, a single-arm neuro-rehabilitation program using smart socks and external stimuli to reduce step-time variability in people with Parkinson's disease.
Secondary ID [1] 298671 0
None
Universal Trial Number (UTN)
U1111-1236-6553
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 313566 0
Mobility impairment 313567 0
Condition category
Condition code
Neurological 311997 311997 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 311998 311998 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314941 0
Treatment: Devices
Intervention code [2] 314942 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320648 0
Overall effect of the intervention on gait stability (step-time variability [ms] assessed by from the middle 18 meters of a 22 meter walk [Henderson et al. 2016]). Change in step time variability between baseline without simulation and followup with smart sock stimulation. Both assessments are "on" medication.
Timepoint [1] 320648 0
Baseline (week 0) without socks and followup (week 3) with socks
Secondary outcome [1] 372318 0
Training effect of the intervention on step-time variability [ms] assessed from the middle 18 meters of a 22 meter walk [Henderson et al. 2016]. Change in step time variability from baseline without simulation to followup without stimulation. (Different to the primary outcome, the training effect is measured as the change in step time variability without sock stimulation at both time points.)
Timepoint [1] 372318 0
Baseline (week 0) without socks and followup (week 3) without socks
Secondary outcome [2] 372319 0
Immediate effect at followup of smart socks (after 2-weeks neuro-rehabilitation) on step-time variability [ms] assessed from the middle 18 meters of a 22 meter walk [Henderson et al. 2016] at followup. (Different to the primary outcome, the immediate effect at followup is measured at a single time point as the change in step time variability without vs with sock stimulation.)
Timepoint [2] 372319 0
Followup (week 3) without vs with socks
Secondary outcome [3] 372360 0
Immediate effect at baseline of smart socks (with minimal training) on step-time variability [ms] assessed from the middle 18 meters of a 22 meter walk [Henderson et al. 2016] at baseline.
Timepoint [3] 372360 0
Baseline (weeks 0) without vs with socks
Secondary outcome [4] 372361 0
Adverse events as a composite outcome including (falls, muscle soreness and other events) reported by the participant that can be attributed to participation in the training. Collected using questionnaires specifically designed for this study.
Timepoint [4] 372361 0
Followup after balance training (week 2) and after stepping and walking training (week 3)
Secondary outcome [5] 372363 0
Training dose tolerance [mins/week] measured by the total minutes of unsupervised training successfully completed for the balance, step and walk training components. Collected automatically by the training apps and for confirmation manually through participant diaries.
Timepoint [5] 372363 0
Followup after balance training (week 2) and after stepping and walking training (week 3)
Secondary outcome [6] 372370 0
End user feedback. Participant's experiences with the intervention and suggestions for improvement will be recorded through structured interviews. Questions will be designed specifically for this study. This will be through one-on-one interviews which will last 30 minutes and be audio-recorded.
Timepoint [6] 372370 0
Home visit 2 after balance training (week 2) and followup assessment, after step/walk training (week 3).
Secondary outcome [7] 372371 0
Usability using an adapted version of the 10-item system usability questionnaire (adapted specifically for this study).
Timepoint [7] 372371 0
Home visit 2 after balance training (week 2) and followup assessment, after step/walk training (week 3).
Secondary outcome [8] 372374 0
Physiological profile assessment (PPA) [Lord et al. 2009].
Timepoint [8] 372374 0
Baseline (week 0) and followup (week 3)
Secondary outcome [9] 372376 0
The icon-FES fear of falling scale.
Timepoint [9] 372376 0
Baseline (week 0) and followup (week 3)
Secondary outcome [10] 372382 0
The Trail-making Test (Wechsler, 1981) will be assessed using an iPad app NeuRA Trails.
Timepoint [10] 372382 0
Baseline (week 0) and followup (week 3)
Secondary outcome [11] 372619 0
Overall effect of the intervention on walking speed [m/s] assessed by wearable device from the middle 18 meters of a 22 meter walk
Timepoint [11] 372619 0
Baseline (week 0) without socks and followup (week 3) with socks
Secondary outcome [12] 372620 0
Overall effect of the intervention on step length [cm] assessed by wearable device from the middle 18 meters of a 22 meter walk.
Timepoint [12] 372620 0
Baseline (week 0) without socks and followup (week 3) with socks
Secondary outcome [13] 372991 0
Overall effect of the intervention on cadence [steps/min] assessed by wearable device from the middle 18 meters of a 22 meter walk.
Timepoint [13] 372991 0
Baseline (week 0) without socks and followup (week 3) with socks
Secondary outcome [14] 372992 0
Overall effect of the intervention on the Freezing of Gait (FoG) elicitation walk (36 meters including postural transitions, walking between chairs and turns). Assessed by number and duration of FoG episodes. [Lord et al. under review].
Timepoint [14] 372992 0
Baseline (week 0) without socks and followup (week 3) with socks
Secondary outcome [15] 373358 0
Perceived value of the intervention. Participants will be asked to assign a hypothetical $ value to each component of the intervention.
Timepoint [15] 373358 0
Followup (week 3)
Secondary outcome [16] 374684 0
Exercise Self-Efficacy Scale questionnaire
Timepoint [16] 374684 0
Home visit 2 after balance training (week 2) and followup assessment, after step/walk training (week 3).
Secondary outcome [17] 374685 0
Physical Activity Enjoyment Scale questionnaire
Timepoint [17] 374685 0
Home visit 2 after balance training (week 2) and followup assessment, after step/walk training (week 3).

Eligibility
Key inclusion criteria
Diagnosed with Parkinson’s disease;
Being stable on anti-Parkinsonian medications for >= 1 month;
Living independently in the community or retirement village;
Able to communicate in English language;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to stand or walk 30m without assistance;
Diagnosis of other neurological and/or significant cognitive impairments (a Pfeiffer Short Portable Mental Status Questionnaire score <5);
Medical conditions which would preclude physical assessments or exercise training using smart socks (e.g. peripheral nephropathy causing inability to perceive external stimulus). Insufficient cognitive or physical capacity to comply with the intervention safely in an unsupervised environment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size of 12 was based on an expected 20% drop out and therefore having at least 10 people compete this preliminary study. Non-normally distributed data will be transformed prior to analysis. Paired t-tests (p-values) and effect sizes (Cohen's d) will be used to report the size of the expected improvement in the primary outcome gait stability (as assessed by step-time variability). Given the pilot design and small sample size all p-values will be reported with no arbitrary threshold used to determine significance.

For this exploratory study, we intend to recruit a heterogeneous cohort of people living with Parkinson's disease and therefore do not expect all participants to show similar improvements in the primary outcome. Participants will be grouped into responders (people with improved gait stability) and non-responders (people without improved gait stability) and assessments will be reported separately for each group. Differences between responders and non-responders will be used to determine the characteristics or participants most suitable for this intervention.

Secondary outcomes. Non-normally distributed data will be transformed prior to analysis. Changes in secondary outcomes will be reported using paired t-tests (p-values) and effect sizes (Cohen's d). Given the pilot design and small sample size all p-values will be reported with no arbitrary threshold used to determine significance. Analysis of the secondary outcomes will further be used to support or oppose the following hypotheses: (A) The overall effect of the intervention (primary outcome) will be split approximately 50/50 between the beneficial training effect (secondary outcome 1) and the beneficial immediate effect of the socks at followup (secondary outcome 2). (B) There will be no change in the physical capacity and cognitive capacity (secondary outcomes 8 and 10) from the 2-week intervention suggesting that the improvement in primary outcome may be primarily attributed to central nervous system and neuromuscular control of gait.

User experiences with WalkingTall will be reported as a narrative synthesis and responses to questionnaires to determine the key enablers, barriers and areas of improvement for the intervention. This information will be used to discuss future design improvements to the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2019
Actual
Date of last participant enrolment
Anticipated
4/11/2019
Actual
Date of last data collection
Anticipated
18/11/2019
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303200 0
Charities/Societies/Foundations
Name [1] 303200 0
The Micheal J. Fox Foundation
Country [1] 303200 0
United States of America
Funding source category [2] 303292 0
Charities/Societies/Foundations
Name [2] 303292 0
Shake It Up Australia Foundation
Country [2] 303292 0
Australia
Primary sponsor type
Individual
Name
Dr Matthew Brodie
Address
Neuroscience Research Australia
139 Barker Street
Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 303314 0
Individual
Name [1] 303314 0
A/Prof Kim Delbaere
Address [1] 303314 0
Neuroscience Research Australia
139 Barker Street, NSW 2031
Country [1] 303314 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303761 0
UNSW Human Research Ethics
Ethics committee address [1] 303761 0
Ethics committee country [1] 303761 0
Australia
Date submitted for ethics approval [1] 303761 0
Approval date [1] 303761 0
01/07/2019
Ethics approval number [1] 303761 0
HC17978

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94706 0
Dr Matthew Brodie
Address 94706 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW 2031
Country 94706 0
Australia
Phone 94706 0
+64 2 9399 1801
Fax 94706 0
+64 2 9399 1120
Email 94706 0
[email protected]
Contact person for public queries
Name 94707 0
Matthew Brodie
Address 94707 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW 2031
Country 94707 0
Australia
Phone 94707 0
+64 2 9399 1801
Fax 94707 0
+64 2 9399 1120
Email 94707 0
[email protected]
Contact person for scientific queries
Name 94708 0
Matthew Brodie
Address 94708 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW 2031
Country 94708 0
Australia
Phone 94708 0
+64 2 9399 1801
Fax 94708 0
+64 2 9399 1120
Email 94708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.