Improving Walking With Heel-To-Toe Device

March 13, 2023 updated by: McGill University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3S5
        • McGill University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Heel2Toe Group
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
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
Other: No-feedback Control Group (Control group)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
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.
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Falls)
Time Frame: Baseline to 3 months.
Self-reported number of falls during study period
Baseline to 3 months.
Technology acceptability (System Usability Scale)
Time Frame: 3 months (1 time point)
Patient-reported outcome on satisfaction and intent-to-use
3 months (1 time point)
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
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)]
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
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
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
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
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)
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
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
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
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
Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
Cognitive performance (Symbol Digit Modality Test)
Time Frame: Baseline, 3 months, 6 months
Performance-rated outcome
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-5842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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