Improving Walking With Heel-To-Toe Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson

Intervention / Treatment
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* Device: Heel2Toe
* Other: No-feedback control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Standard two-group, sequential design, with 2:1 randomization (intervention:control) and only a within-group analysis.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heel2Toe Group<br>The Heel2Toe group will have 5 therapy sessions to learn to trigger the sensor with a strong heel strike and how to use device for home practice for 3 months. During the home practice, participants will be instructed to walk with the device for a minimum of 10 minutes per day in feedback mode. They will be provided with a workbook outlining simple exercises targeting functions needed to walk well (Walk-BEST Workbook) in paper and as a mobile app. | Device: Heel2Toe<br>* 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<br>|
| Other: No-feedback Control Group (Control group)<br>The Control group will do the same 5 sessions of training and 3 months of practice but without the Heel2Toe device in feedback mode, just in data acquisition mode. They will be provided with a workbook outlining simple exercises targeting functions needed to walk well (Walk-BEST Workbook) in paper and as a mobile app. | Other: No-feedback control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliable Change in Six-Minute Walk Test | Performance-rated outcome | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 
| Change in Standardized Walking Obstacle Course (SWOC) | 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. | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Falls) | Self-reported number of falls during study period | Baseline to 3 months. | 
| Technology acceptability (System Usability Scale) | Patient-reported outcome on satisfaction and intent-to-use | 3 months (1 time point) | 
| Change in Gait Quality (Data capture from Heel2Toe sensor) | Technologically-reported outcome | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)] | 
| Change in Lower Extremity Function (Neuroqol) | Patient-reported outcome on degree of difficulty with activities related lower extremity function | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 
| Change in Postural Instability and Gait Dysfunction (UPDRS) | Self-reported outcome of limitations | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 
| Change in health-related quality of life (EQ-5D-3L) | Patient-reported outcome (EQ-5D-3L) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 
| Change in motivation (Starkstein Apathy Scale, Activity Effort Inventory) | Patient-reported outcome | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 
| Change in health states (Visual Analogue Health States) | Patient reported outcome of 8 health states measured on 0 to 10 scale | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 
| Cognitive performance (Symbol Digit Modality Test) | Performance-rated outcome | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, walking capacity, neuroplasticity, motor learning, quality of life