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Model-based Cueing-as-needed for Walking in Parkinson's Disease (GAITPARK)

Primary Purpose

Parkinson Disease, Walking, Difficulty, Gait, Festinating

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
20-minute gait training
Sponsored by
Henri Mondor University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Basal Ganglia Diseases, Gait analysis, Gait Speed, Cues, Exercise Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: the diagnosis of idiopathic PD based on the United Kingdom-Parkinson's Disease Society Brain Bank criteria; stage 2 or 3 on the Hoehn and Yahr scale; comfortable walking speed over 10 meters ≤ 1 m/s; ability to walk over 20 minutes without aids or antiparkinsonian medications; a stable antiparkinsonian medication regime; cognitive abilities to understand the verbal instructions for a walking test according to the investigator's judgment; written consent for the participation. Exclusion Criteria: intercurrent disease other than PD, affecting gait; any intercurrent medical condition preventing them from participating in two consecutive gait training one week apart; medical diagnosis of hearing loss; non-affiliation to the social security regime.

Sites / Locations

  • Laboratoire Analyse et Restauration du Mouvement

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rhythmic auditory cueing

Adaptive spatial auditory cueing

Arm Description

The rhythmic auditory cueing (RAC) is a constant stimulation ("bip" signal) delivered by a numeric metronome, which is adjusted on 110% of the patient's own cadence.

Adaptive spatial auditory cueing (ASAC) is a verbal instruction stimulation delivered by an application when the stride length of the patient is less than a predetermined threshold, during two consecutive strides. The instruction is given in the patient's native language, which is French: "allongez le pas" (i.e. "lengthen the step"). The predetermined threshold is 110% of the patient's own stride length.

Outcomes

Primary Outcome Measures

Walking speed
Speed in free walking condition over 10 meters barefoot, without any assistance

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 9, 2023
Sponsor
Henri Mondor University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06073028
Brief Title
Model-based Cueing-as-needed for Walking in Parkinson's Disease
Acronym
GAITPARK
Official Title
Model-based Cueing-as-needed for Walking in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henri Mondor University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease.
Detailed Description
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease. Fifteen patients with Parkinson's disease performed both interventions in randomized order, one week apart: a 20-minute walking training with rhythmic auditory cueing, in form of a metronome adjusted on 110% of the patient's own cadence, or ASAC delivered when the stride length is less than 110% of the patient's own stride length. Assessment criteria were walking distance covered during the intervention, speed, step length, cadence, coefficients of variation of step length and step duration, and indexes of spatial and temporal asymmetry during a walking test before and just after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Walking, Difficulty, Gait, Festinating
Keywords
Basal Ganglia Diseases, Gait analysis, Gait Speed, Cues, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pilot single-blind randomized cross-over study, with the subject blind as to the hypothesis
Masking
Outcomes Assessor
Masking Description
A biomechanics engineer leads the gait assessment, being blinded to the allocation schedule, and participants were specifically asked to not discuss the intervention.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhythmic auditory cueing
Arm Type
Experimental
Arm Description
The rhythmic auditory cueing (RAC) is a constant stimulation ("bip" signal) delivered by a numeric metronome, which is adjusted on 110% of the patient's own cadence.
Arm Title
Adaptive spatial auditory cueing
Arm Type
Experimental
Arm Description
Adaptive spatial auditory cueing (ASAC) is a verbal instruction stimulation delivered by an application when the stride length of the patient is less than a predetermined threshold, during two consecutive strides. The instruction is given in the patient's native language, which is French: "allongez le pas" (i.e. "lengthen the step"). The predetermined threshold is 110% of the patient's own stride length.
Intervention Type
Other
Intervention Name(s)
20-minute gait training
Intervention Description
All subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8).
Primary Outcome Measure Information:
Title
Walking speed
Description
Speed in free walking condition over 10 meters barefoot, without any assistance
Time Frame
Before and just after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the diagnosis of idiopathic PD based on the United Kingdom-Parkinson's Disease Society Brain Bank criteria; stage 2 or 3 on the Hoehn and Yahr scale; comfortable walking speed over 10 meters ≤ 1 m/s; ability to walk over 20 minutes without aids or antiparkinsonian medications; a stable antiparkinsonian medication regime; cognitive abilities to understand the verbal instructions for a walking test according to the investigator's judgment; written consent for the participation. Exclusion Criteria: intercurrent disease other than PD, affecting gait; any intercurrent medical condition preventing them from participating in two consecutive gait training one week apart; medical diagnosis of hearing loss; non-affiliation to the social security regime.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hutin Emilie, PhD
Organizational Affiliation
HenriMondorHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire Analyse et Restauration du Mouvement
City
Créteil
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Model-based Cueing-as-needed for Walking in Parkinson's Disease

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