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

NCT04613141 | Completed

• 1 other identifier: WalkingTallPD2019
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Falls; Step-time variability; Freezing of Gait

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 3-month re-assessment

• 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.

  Baseline and 3-month re-assessment

Secondary Outcomes (22)

• Rate of falling

  Baseline and post-intervention (3-months)

• Levodopa equivalency daily dosage

  Baseline and post-intervention (3-months)

• Postural balance and mobility

  Baseline and post-intervention (3-months)

• Physical activity enjoyment

  Post-intervention (3-months)

• System usability

  Post-intervention (3-months)

Study Arms (2)

Mobility-plus

SHAM COMPARATOR

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

WalkingTall-PD

EXPERIMENTAL

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

Interventions

WalkingTall-PD DEVICE

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.

WalkingTall-PD

Mobility-plus OTHER

Active 'pseudo placebo' comparator using a paper-based body weight exercise program.

Mobility-plus

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuroscience Research Australia: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Shake it up Australia Foundation: collaborator
• Sensoria Health Inc.: collaborator

Study Sites (1)

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

Location

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Matthew A Brodie, Dr

  The University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: July 15, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

AU (1)