Improving Walking With Heel-To-Toe Device

Parkinson Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300348
• Other study ID #: 2020-5842
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2023
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliable Change in Six-Minute Walk Test	Performance-rated outcome	Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
Primary	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	Safety (Falls)	Self-reported number of falls during study period	Baseline to 3 months.
Secondary	Technology acceptability (System Usability Scale)	Patient-reported outcome on satisfaction and intent-to-use	3 months (1 time point)
Secondary	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)]
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Cognitive performance (Symbol Digit Modality Test)	Performance-rated outcome	Baseline, 3 months, 6 months

External Links

•   Website for the company that produces Heel2Toe(TM)