NCT04300348

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

March 4, 2020

Last Update Submit

March 13, 2023

Conditions

Parkinson

Keywords

gaitwalking capacityneuroplasticitymotor learningquality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Safety (Falls)

    Baseline to 3 months.

  • Technology acceptability (System Usability Scale)

    3 months (1 time point)

  • Change in Gait Quality (Data capture from Heel2Toe sensor)

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

  • Change in Lower Extremity Function (Neuroqol)

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

  • Change in Postural Instability and Gait Dysfunction (UPDRS)

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

  • +4 more secondary outcomes

Study Arms (2)

Heel2Toe Group

ACTIVE COMPARATOR

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

No-feedback Control Group (Control group)

OTHER

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

Interventions

Heel2ToeDEVICE

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

Heel2Toe Group
No-feedback control groupOTHER

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.

No-feedback Control Group (Control group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3S5, Canada

Location

Related Publications (3)

  • Mate KKV, Abou-Sharkh A, Morais JA, Mayo NE. Putting the best foot forward: Relationships between indicators of step quality and cadence in three gait vulnerable populations. NeuroRehabilitation. 2019;44(2):295-301. doi: 10.3233/NRE-182595.

    PMID: 30856128BACKGROUND

  • Mate KK, Abou-Sharkh A, Morais JA, Mayo NE. Real-Time Auditory Feedback-Induced Adaptation to Walking Among Seniors Using the Heel2Toe Sensor: Proof-of-Concept Study. JMIR Rehabil Assist Technol. 2019 Dec 11;6(2):e13889. doi: 10.2196/13889.

    PMID: 31825320BACKGROUND

  • Carvalho LP, Mate KKV, Cinar E, Abou-Sharkh A, Lafontaine AL, Mayo NE. A new approach toward gait training in patients with Parkinson's Disease. Gait Posture. 2020 Sep;81:14-20. doi: 10.1016/j.gaitpost.2020.06.031. Epub 2020 Jun 29.

    PMID: 32650238BACKGROUND

Related Links

Study Officials

  • Nancy Mayo, PhD

    Research Institute - MUHC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An evaluator who does not know to which group the participant was assigned will conduct the evaluations. The outcomes are tests of performance.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Standard two-group, sequential design, with 2:1 randomization (intervention:control) and only a within-group analysis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

April 15, 2021

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)