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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04613141




Registration number
NCT04613141
Ethics application status
Date submitted
27/10/2020
Date registered
3/11/2020
Date last updated
5/09/2021

Titles & IDs
Public title
The WalkingTall Study: Comparing WalkingTall With Parkinson's Disease (WalkingTall-PD) With Mobility-plus to Reduce Falls and Improve Mobility.
Scientific title
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).
Secondary ID [1] 0 0
WalkingTallPD2019
Universal Trial Number (UTN)
Trial acronym
WalkingTall-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WalkingTall-PD
Other interventions - Mobility-plus

Sham Comparator: Mobility-plus - Mobility-plus is a "pseudo placebo" comparator program using non-slip socks, a low intensity paper-based exercise program and health information specific to Parkinson's Disease.

Experimental: WalkingTall-PD - WalkingTall-PD is a novel neuro-rehabilitation program delivered through a tablet/smart phone and smart garments (socks, insoles or ankle bands) for people with Parkinson's disease that aims to improve mobility and reduce falls. WalkingTall-PD combines a variety of PD-specific rhythmic stimuli (auditory, visual and haptic cues) which are synchronised with high intensity stepping, walking and balance training.


Treatment: Devices: WalkingTall-PD
Smart garment (socks, insoles or ankle bands) delivering rhythmic haptic stimuli to the ankle timed with preferred cadence. Smart phone application delivers auditory cues synchronised with haptic stimuli. Smart phone application delivers a neurorehabilitation program.

Other interventions: Mobility-plus
Active 'pseudo placebo' comparator using a paper-based body weight exercise program.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gait variability (immediate effect of stimulation) - Standard deviation of step times will be assessed by a wearable device (McRoberts). This will be measured for both face-to-face and telehealth options. Baseline walking is compared to baseline walking with simulation (for the intervention group) and compared to walking with non-slip socks (for the control group). This will be repeated at 3-months. For face to face, gait variability will be assessed using the middle 16m of 4 x 20m straight line walks. For telehealth, it may not be possible to find a 20m straight line walking track, in which case more laps will be required to get a total distance of at least 80 meters. Regardless of the face to face or telehealth option, the same walking track will be used by each participant for each assessment to ensure consistency.
Timepoint [1] 0 0
Baseline and 3-month re-assessment
Primary outcome [2] 0 0
Gait variability (no stimulation) - Standard deviation of step times will be assessed by a wearable device (McRoberts). This will be measured for both face-to-face and telehealth options. For both baseline and re-assessment the no stimulation condition is used. For face to face, gait variability will be assessed using the middle 16m of 4 x 20m straight line walks. For telehealth, it may not be possible to find a 20m straight line walking track, in which case more laps will be required to get a total distance of at least 80 meters. Regardless of the face to face or telehealth option, the same walking track will be used by each participant for each assessment to ensure consistency.
Timepoint [2] 0 0
Baseline and 3-month re-assessment
Secondary outcome [1] 0 0
Rate of falling - Rate of falling will be ascertained using weekly electronic falls calendars and email reminders. This will be measured for both face-to-face and telehealth options.
Timepoint [1] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [2] 0 0
Levodopa equivalency daily dosage - This will be measured for both face-to-face and telehealth options.
Timepoint [2] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [3] 0 0
Postural balance and mobility - Postural balance and mobility using the Mini-best test. This will be measured for both face-to-face and telehealth options. Although, this assessment will be adapted for telehealth purpose. Only items that are safer to be undertaken without a therapist support will be performed.
Timepoint [3] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [4] 0 0
Physical activity enjoyment - Physical activity enjoyment will be assessed using Physical Activity Enjoyment Scale Questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [4] 0 0
Post-intervention (3-months)
Secondary outcome [5] 0 0
System usability - System usability will be assessed using System Usability Scale Questionnaire. This will be measured for both face-to-face and telehealth options, and only for individuals who will receive the Walking-Tall PD training.
Timepoint [5] 0 0
Post-intervention (3-months)
Secondary outcome [6] 0 0
Attitudes to fall related intervention - Attitudes to fall related intervention will be assessed using Attitudes to Fall Related Intervention Scale Questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [6] 0 0
Post-intervention (3-months)
Secondary outcome [7] 0 0
Exercise self-efficacy - Exercise self-efficacy will be assessed using Exercise Self-Efficacy Scale Questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [7] 0 0
Post-intervention (3-months)
Secondary outcome [8] 0 0
Health-related quality of life - Health-related quality of life will be assessed using the European Quality of Life-5 EQ-5D. This will be measured for both face-to-face and telehealth options.
Timepoint [8] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [9] 0 0
Parkinson's disease health status - Parkinson's disease health status using a PD-specific quality-of-life questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [9] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [10] 0 0
Lower extremity physical performance - Lower extremity physical performance will be assessed using the Short Physical Performance Battery. This will be measured for both face-to-face and telehealth options.
Timepoint [10] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [11] 0 0
Parkinson's disease symptoms - Parkinson's disease symptoms will be assessed using the Movement Disorders Society - Unified Parkinson's Disease Rating Scale. This will be measured for both face-to-face and telehealth options. Although, this assessment will be adapted for telehealth purpose.
Timepoint [11] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [12] 0 0
Freezing of gait - Freezing of gait will be assessed using the New Freezing of Gait Questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [12] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [13] 0 0
Concern about falling - Concern about falling will be assessed using the Iconographical Falls Efficacy Scale Questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [13] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [14] 0 0
Physical activity level - Activity levels will be assessed using the Incidental and Planned Exercise Questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [14] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [15] 0 0
Activity of daily living - Activities of daily living will be assessed using 1-week remote monitoring, including total steps/day, step-time variability, uninterrupted walk durations, falls, near falls and freezing of gait events. This will be measured for both face-to-face and telehealth options.
Timepoint [15] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [16] 0 0
Exercise adherence - Exercise adherence will be assessed using monthly exercise calendars. An e-mail with a web link will be send to the participants, and they will be asked to report if any falls happened in a previous month. This will be measured for both face-to-face and telehealth options.
Timepoint [16] 0 0
Post-intervention (3-months)
Secondary outcome [17] 0 0
Health service use - Health service use will be assessed using a monthly questionnaire. This will be measured for both face-to-face and telehealth options.
Timepoint [17] 0 0
Post-intervention (3-months)
Secondary outcome [18] 0 0
Freezing of gait - Freezing of gait will be assessed by a wearable device during a freezing of gait elicitation protocol. This will be only measured for the face-to-face option.
Timepoint [18] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [19] 0 0
Simple stepping ability - Simple stepping ability and reaction time will be assessed using the choice stepping reaction time test.
They will be only measured for face-to-face option.
Timepoint [19] 0 0
Baseline (week 1) and post-intervention (7 weeks after randomisation).
Secondary outcome [20] 0 0
Inhibitory stepping ability - Inhibitory stepping ability and reaction time will be assessed using the inhibitory choice stepping reaction time test.
They will be only measured for face-to-face option.
Timepoint [20] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [21] 0 0
Complex stepping ability - Complex stepping ability and reaction time will be assessed using the stroop stepping test.
They will be only measured for face-to-face option.
Timepoint [21] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [22] 0 0
Polypharmacy - Change in polypharmacy (the amount of medication taken). This will be measured for both face-to-face and telehealth options.
Timepoint [22] 0 0
Baseline and post-intervention (3-months)

Eligibility
Key inclusion criteria
- Have been diagnosed with idiopathic Parkinson's disease (according to UK PD Society
Brain Bank Criteria);

- Mild to severe (Hoehn and Yahr stage 1-4 idiopathic Parkinson's disease;

- Ability to walk 18 meters with or without an aid;

- At least one fall in the past 6 months, or at least 2 falls in the past 12 months, or
severe mobility impairment such as freezing of gait, or history of near falls.

- 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
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of other neurological and/ or significant cognitive impairments (Montreal
Cognitive Assessment < 19 points);

- Atypical Parkinsonism;

- Less than 6 months post deep brain stimulation surgery;

- Excessively high fall rates (> 12 falls in the past 6 months);

- Insufficient foot/ ankle sensation;

- Do not speak English;

- Have another medical condition besides Parkinson's disease that significantly impairs
mobility, balance or ability to exercise safely;

- Already participating in a different study to improve mobility or prevent falls.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Michael J. Fox Foundation for Parkinson's Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Shake it up Australia Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sensoria Health Inc.
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine and compare the effectiveness of WalkingTall-PD
(the new intervention) against Mobility-plus (a PD appropriate exercise program) with respect
to stabilizing gait, reducing step-time variability, preventing falls and enhancing
independence in people with Parkinson's disease.

WalkingTall-PD is a novel neuro-rehabilitation program delivered through a tablet/smart phone
and smart socks for people with Parkinson's disease that aims to improve mobility and reduce
falls. WalkingTall-PD combines a variety of PD-specific rhythmic stimuli (auditory, visual
and haptic cues) which are synchronised with high intensity stepping, walking and balance
training.

Mobility-plus is a "pseudo placebo" comparator program using non-slip socks, a low intensity
paper-based exercise program and health information specific to Parkinson's Disease.
Trial website
https://clinicaltrials.gov/show/NCT04613141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew A Brodie, Dr
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04613141