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The WalkingTall Study: Comparing WalkingTall With Parkinson's Disease (WalkingTall-PD) With Mobility-plus to Reduce Falls and Improve Mobility. (WalkingTall-PD)

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ClinicalTrials.gov Identifier: NCT04613141
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2020
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Shake it up Australia Foundation
Sensoria Health Inc.
Information provided by (Responsible Party):
Neuroscience Research Australia

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: WalkingTall-PD Other: Mobility-plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Assessments that occur after baseline randomization will be completed by blinded assessor. Excluding the immediate effect of stimulation on step time variability, which is impossible to blind as the participant using a stimulation device, which is not practical to conceal.

Statistician blinded.

Primary Purpose: Other
Official 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).
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Mobility-plus
Active 'pseudo placebo' comparator using a paper-based body weight exercise program.

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.
Device: 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.




Primary Outcome Measures :
  1. Gait variability (immediate effect of stimulation) [ Time Frame: Baseline and 3-month re-assessment ]
    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.

  2. Gait variability (no stimulation) [ Time Frame: Baseline and 3-month re-assessment ]
    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.


Secondary Outcome Measures :
  1. Rate of falling [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  2. Levodopa equivalency daily dosage [ Time Frame: Baseline and post-intervention (3-months) ]
    This will be measured for both face-to-face and telehealth options.

  3. Postural balance and mobility [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  4. Physical activity enjoyment [ Time Frame: Post-intervention (3-months) ]
    Physical activity enjoyment will be assessed using Physical Activity Enjoyment Scale Questionnaire. This will be measured for both face-to-face and telehealth options.

  5. System usability [ Time Frame: Post-intervention (3-months) ]
    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.

  6. Attitudes to fall related intervention [ Time Frame: Post-intervention (3-months) ]
    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.

  7. Exercise self-efficacy [ Time Frame: Post-intervention (3-months) ]
    Exercise self-efficacy will be assessed using Exercise Self-Efficacy Scale Questionnaire. This will be measured for both face-to-face and telehealth options.

  8. Health-related quality of life [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  9. Parkinson's disease health status [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  10. Lower extremity physical performance [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  11. Parkinson's disease symptoms [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  12. Freezing of gait [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  13. Concern about falling [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  14. Physical activity level [ Time Frame: Baseline and post-intervention (3-months) ]
    Activity levels will be assessed using the Incidental and Planned Exercise Questionnaire. This will be measured for both face-to-face and telehealth options.

  15. Activity of daily living [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  16. Exercise adherence [ Time Frame: Post-intervention (3-months) ]
    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.

  17. Health service use [ Time Frame: Post-intervention (3-months) ]
    Health service use will be assessed using a monthly questionnaire. This will be measured for both face-to-face and telehealth options.

  18. Freezing of gait [ Time Frame: Baseline and post-intervention (3-months) ]
    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.

  19. Simple stepping ability [ Time Frame: Baseline (week 1) and post-intervention (7 weeks after randomisation). ]

    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.


  20. Inhibitory stepping ability [ Time Frame: Baseline and post-intervention (3-months) ]

    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.


  21. Complex stepping ability [ Time Frame: Baseline and post-intervention (3-months) ]

    Complex stepping ability and reaction time will be assessed using the stroop stepping test.

    They will be only measured for face-to-face option.


  22. Polypharmacy [ Time Frame: Baseline and post-intervention (3-months) ]
    Change in polypharmacy (the amount of medication taken). This will be measured for both face-to-face and telehealth options.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613141


Locations
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Australia, New South Wales
Neuroscience Research Australia
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
Neuroscience Research Australia
Michael J. Fox Foundation for Parkinson's Research
Shake it up Australia Foundation
Sensoria Health Inc.
Investigators
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Principal Investigator: Matthew A Brodie, Dr The University of New South Wales
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Responsible Party: Neuroscience Research Australia
ClinicalTrials.gov Identifier: NCT04613141    
Other Study ID Numbers: WalkingTallPD2019
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neuroscience Research Australia:
Falls
Step-time variability
Freezing of Gait
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases