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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.
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)
Timepoint [1] 0 0
Baseline and 3-month re-assessment
Primary outcome [2] 0 0
Gait variability (no stimulation)
Timepoint [2] 0 0
Baseline and 3-month re-assessment
Secondary outcome [1] 0 0
Rate of falling
Timepoint [1] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [2] 0 0
Levodopa equivalency daily dosage
Timepoint [2] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [3] 0 0
Postural balance and mobility
Timepoint [3] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [4] 0 0
Physical activity enjoyment
Timepoint [4] 0 0
Post-intervention (3-months)
Secondary outcome [5] 0 0
System usability
Timepoint [5] 0 0
Post-intervention (3-months)
Secondary outcome [6] 0 0
Attitudes to fall related intervention
Timepoint [6] 0 0
Post-intervention (3-months)
Secondary outcome [7] 0 0
Exercise self-efficacy
Timepoint [7] 0 0
Post-intervention (3-months)
Secondary outcome [8] 0 0
Health-related quality of life
Timepoint [8] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [9] 0 0
Parkinson's disease health status
Timepoint [9] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [10] 0 0
Lower extremity physical performance
Timepoint [10] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [11] 0 0
Parkinson's disease symptoms
Timepoint [11] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [12] 0 0
Freezing of gait
Timepoint [12] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [13] 0 0
Concern about falling
Timepoint [13] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [14] 0 0
Physical activity level
Timepoint [14] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [15] 0 0
Activity of daily living
Timepoint [15] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [16] 0 0
Exercise adherence
Timepoint [16] 0 0
Post-intervention (3-months)
Secondary outcome [17] 0 0
Health service use
Timepoint [17] 0 0
Post-intervention (3-months)
Secondary outcome [18] 0 0
Freezing of gait
Timepoint [18] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [19] 0 0
Simple stepping ability
Timepoint [19] 0 0
Baseline (week 1) and post-intervention (7 weeks after randomisation).
Secondary outcome [20] 0 0
Inhibitory stepping ability
Timepoint [20] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [21] 0 0
Complex stepping ability
Timepoint [21] 0 0
Baseline and post-intervention (3-months)
Secondary outcome [22] 0 0
Polypharmacy
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2022
Sample size
Target
Accrual to date
Final
62
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/study/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/study/NCT04613141