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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06073028
Other study ID # GAITPARK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date February 1, 2022

Study information

Verified date October 2023
Source Henri Mondor University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date February 1, 2022
Est. primary completion date February 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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).

Locations

Country Name City State
France Laboratoire Analyse et Restauration du Mouvement Créteil

Sponsors (1)

Lead Sponsor Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walking speed Speed in free walking condition over 10 meters barefoot, without any assistance Before and just after the intervention
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