Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04613141
Registration number
NCT04613141
Ethics application status
Date submitted
27/10/2020
Date registered
3/11/2020
Date last updated
5/10/2022
Titles & IDs
Public title
The WalkingTall Study: Comparing WalkingTall With Parkinson's Disease (WalkingTall-PD) With Mobility-plus to Reduce Falls and Improve Mobility.
Query!
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).
Query!
Secondary ID [1]
0
0
WalkingTallPD2019
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
WalkingTall-PD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Parkinson's disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Gait variability (immediate effect of stimulation)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and 3-month re-assessment
Query!
Primary outcome [2]
0
0
Gait variability (no stimulation)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and 3-month re-assessment
Query!
Secondary outcome [1]
0
0
Rate of falling
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [2]
0
0
Levodopa equivalency daily dosage
Query!
Assessment method [2]
0
0
This will be measured for both face-to-face and telehealth options.
Query!
Timepoint [2]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [3]
0
0
Postural balance and mobility
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [4]
0
0
Physical activity enjoyment
Query!
Assessment method [4]
0
0
Physical activity enjoyment will be assessed using Physical Activity Enjoyment Scale Questionnaire. This will be measured for both face-to-face and telehealth options.
Query!
Timepoint [4]
0
0
Post-intervention (3-months)
Query!
Secondary outcome [5]
0
0
System usability
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Post-intervention (3-months)
Query!
Secondary outcome [6]
0
0
Attitudes to fall related intervention
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Post-intervention (3-months)
Query!
Secondary outcome [7]
0
0
Exercise self-efficacy
Query!
Assessment method [7]
0
0
Exercise self-efficacy will be assessed using Exercise Self-Efficacy Scale Questionnaire. This will be measured for both face-to-face and telehealth options.
Query!
Timepoint [7]
0
0
Post-intervention (3-months)
Query!
Secondary outcome [8]
0
0
Health-related quality of life
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [9]
0
0
Parkinson's disease health status
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [10]
0
0
Lower extremity physical performance
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [11]
0
0
Parkinson's disease symptoms
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [12]
0
0
Freezing of gait
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [13]
0
0
Concern about falling
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [14]
0
0
Physical activity level
Query!
Assessment method [14]
0
0
Activity levels will be assessed using the Incidental and Planned Exercise Questionnaire. This will be measured for both face-to-face and telehealth options.
Query!
Timepoint [14]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [15]
0
0
Activity of daily living
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [16]
0
0
Exercise adherence
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Post-intervention (3-months)
Query!
Secondary outcome [17]
0
0
Health service use
Query!
Assessment method [17]
0
0
Health service use will be assessed using a monthly questionnaire. This will be measured for both face-to-face and telehealth options.
Query!
Timepoint [17]
0
0
Post-intervention (3-months)
Query!
Secondary outcome [18]
0
0
Freezing of gait
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [19]
0
0
Simple stepping ability
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Baseline (week 1) and post-intervention (7 weeks after randomisation).
Query!
Secondary outcome [20]
0
0
Inhibitory stepping ability
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [21]
0
0
Complex stepping ability
Query!
Assessment method [21]
0
0
Complex stepping ability and reaction time will be assessed using the stroop stepping test.
They will be only measured for face-to-face option.
Query!
Timepoint [21]
0
0
Baseline and post-intervention (3-months)
Query!
Secondary outcome [22]
0
0
Polypharmacy
Query!
Assessment method [22]
0
0
Change in polypharmacy (the amount of medication taken). This will be measured for both face-to-face and telehealth options.
Query!
Timepoint [22]
0
0
Baseline and post-intervention (3-months)
Query!
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.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/07/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/09/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
62
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Neuroscience Research Australia - Randwick
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Neuroscience Research Australia
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Michael J. Fox Foundation for Parkinson's Research
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Shake it up Australia Foundation
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Sensoria Health Inc.
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04613141
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Matthew A Brodie, Dr
Query!
Address
0
0
The University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04613141
Download to PDF