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

NCT06073028 | Completed

• 1 other identifier: GAITPARK
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Walking, Difficulty; Gait, Festinating

Keywords

Basal Ganglia Diseases; Gait analysis; Gait Speed; Cues; Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Walking speed

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

  Before and just after the intervention

Study Arms (2)

Rhythmic auditory cueing

EXPERIMENTAL

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

Adaptive spatial auditory cueing

EXPERIMENTAL

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

Interventions

20-minute gait training 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; Rhythmic auditory cueing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henri Mondor University Hospital: lead

Study Sites (1)

Laboratoire Analyse et Restauration du Mouvement

Créteil, France

Location

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation; Gait Disorders, Neurologic; Basal Ganglia Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Hutin Emilie, PhD

  HenriMondorHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A biomechanics engineer leads the gait assessment, being blinded to the allocation schedule, and participants were specifically asked to not discuss the intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Pilot single-blind randomized cross-over study, with the subject blind as to the hypothesis

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: February 1, 2021
• Primary Completion: February 2, 2021
• Study Completion: February 1, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)