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Improving Walking With Heel-To-Toe Device

NCT04300348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-03-15

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson

Interventions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Nancy Mayo, PhD · Research Institute - MUHC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-10-30
Completion
2022-10-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300348 on ClinicalTrials.gov