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Completed

NCT Number: NCT04300348

Improving Walking With Heel-To-Toe Device

Introduction: The purpose of this study is to test the efficacy potential of using real-time positive auditory feedback to improve gait pattern in people with Parkinson's Disease (PD). The components of walking are commonly affected in patients with PD. Gait training for PD is usually based on verbal cues from the therapist that are only moderately effective. Based on good principals of gait and neuroplasticity, the Heel-To-Toe (Heel2Toe) sensor was developed to provide real-time auditory feedback during walking training. Methods: A two-group, randomized feasibility trial is planned with repeated measures of gait parameters and walking outcomes. Participants will be assessed at baseline, 3 and 6 months. Outcomes after the 5 training days will be obtained directly from the Hee2Toe device for both groups (with and without auditory feedback). The primary outcome is walking capacity measured by the Six-Minute Walk Test and the Standardized Walking Obstacle Course. Gait parameters will be captured by the Heel2Toe device Expected Contributions: Gait training using the Heel2Toe sensor will be potentially effective for improving walking pattern in people with PD.

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Key information

Conditions

Parkinson

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center

Montreal, Quebec, H4A 3S5, Canada

About this study

As this is a feasibility study, the main analysis will focus on within-group change over the intervention period of 3 months using indices of reliable change(36). This method assesses the number of people who changed in each of the groups based on the magnitude of change relative to pre-post variability and correlation. We will estimate the proportion of people with reliable change. Estimates from the pilot study will be used to plan the main trial if the pilot demonstrates feasibility. For the maintenance period, reliable change from baseline will also be estimated and used to identify the proportion of people who maintained reliable change or who gained/lost this status.

The study is designed to detect a minimal important within-group change of moderate magnitude or greater (effect size ½ standard deviation) with adequate precision. A sample size of 20 in the intervention with completed follow-up will provide a 95% confidence interval with precision that excludes an effect size of 0.03.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Parkinson Disease and be independent in ambulation without use of walking aid

Exclusion criteria

  • exercising three or more time per week;
  • Had any additional illness that restricted their function
  • Showing difficulty reading, understanding or speaking either French or English

Treatment and study plan

Heel2Toe

Device

Heel to Toe (Heel2Toe) is a device that clips on the shoe and provides an instant auditory feedback (a beep) for each correct step characterized by putting the heel first and it provides data on gait parameters

No-feedback control group

Other

The control group will follow the same protocol as the Heel2Toe group but the device will not be in feedback mode just in data acquisition mode.

Primary outcomes

  1. Reliable Change in Six-Minute Walk Test

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Performance-rated outcome

  2. Change in Standardized Walking Obstacle Course (SWOC)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Performance-rated outcome of challenges experienced with starting, stopping, turning, making motor decisions. The metric is the time to complete a 12.2-m long, 0.92-m wide curved pathway, with obstacles commonly encountered in daily life.

Secondary outcomes

  1. Safety (Falls)

    Time frame: Baseline to 3 months.

    Self-reported number of falls during study period

  2. Technology acceptability (System Usability Scale)

    Time frame: 3 months (1 time point)

    Patient-reported outcome on satisfaction and intent-to-use

  3. Change in Gait Quality (Data capture from Heel2Toe sensor)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)]

    Technologically-reported outcome

  4. Change in Lower Extremity Function (Neuroqol)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Patient-reported outcome on degree of difficulty with activities related lower extremity function

  5. Change in Postural Instability and Gait Dysfunction (UPDRS)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Self-reported outcome of limitations

  6. Change in health-related quality of life (EQ-5D-3L)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Patient-reported outcome (EQ-5D-3L)

  7. Change in motivation (Starkstein Apathy Scale, Activity Effort Inventory)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Patient-reported outcome

  8. Change in health states (Visual Analogue Health States)

    Time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

    Patient reported outcome of 8 health states measured on 0 to 10 scale

  9. Cognitive performance (Symbol Digit Modality Test)

    Time frame: Baseline, 3 months, 6 months

    Performance-rated outcome

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

Real-time Auditory Feedback for Improving Gait and Walking in People With Parkinson's Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2020
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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