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

Sponsor

Henri Mondor University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06073028

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Walking, Difficulty Gait, Festinating	Other: 20-minute gait training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Pilot single-blind randomized cross-over study, with the subject blind as to the hypothesisPilot single-blind randomized cross-over study, with the subject blind as to the hypothesis

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Feb 2, 2021

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rhythmic auditory cueing 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.	Other: 20-minute gait training All subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8).
Experimental: Adaptive spatial auditory cueing 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.	Other: 20-minute gait training All subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8).

Arm

Intervention/Treatment

Experimental: Rhythmic auditory cueing

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.

Other: 20-minute gait training

All subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8).

Experimental: Adaptive spatial auditory cueing

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.

Other: 20-minute gait training

All subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8).

Outcome Measures

Primary Outcome Measures

Walking speed [Before and just after the intervention]
Speed in free walking condition over 10 meters barefoot, without any assistance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.