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

NCT ID: NCT06073028

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-01

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.

Conditions

Parkinson Disease; Walking, Difficulty; Gait, Festinating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

20-minute gait training

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

20-minute gait training

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henri Mondor University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emilie Hutin

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hutin Emilie, PhD

Role: PRINCIPAL_INVESTIGATOR

HenriMondorHU

Locations

Laboratoire Analyse et Restauration du Mouvement

Créteil, , France

Countries

France

Other Identifiers

GAITPARK

Identifier Type: -

Identifier Source: org_study_id