Effect of Haptic Cueing on Long-Range Autocorrelations in Parkinson's Disease Gait Variability

NCT05790759 | Completed DMC

• 1 other identifier: NMSK - Lheureux 03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Parkinson's Disease (PD) patients suffer from gait impairments responsible for falls and bad quality of life: reduced speed and stride length, randomness in the temporal organization of stride duration variability (reduced Long-Range Autocorrelations (LRA)). For years, auditory cueing has been used to modulate PD gait and its effect on LRA is known. Less is known regarding the effects of haptic cueing on PD gait and especially on LRA. This pilot study will compare the spatio-temporal gait parameters and LRA of PD patients tested under three conditions: walking without cueing, walking with auditory cueing and walking with haptic cueing by means of rhythmic vibrations on the patients' wrists.

Conditions

Parkinson Disease; Gait, Unsteady

Keywords

Parkinson's Disease; Gait; Long-Range Autocorrelations; Cueing; Rhytmic stimulations

Outcome Measures

Primary Outcomes (1)

• Long-Range Autocorrelations

  Long-Range Autocorrelations computation using the evenly spaced version of the Detrended Fluctuations Analysis

  Change from baseline in long-range autocorrelations during each intervention condition (3 x 10 min walking)

Secondary Outcomes (4)

• Mean Gait Speed

  Change from baseline in mean gait speed during each intervention condition (3 x 10 min walking)

• Step Length

  Change from baseline in step length during each intervention condition (3 x 10 min walking)

• Gait Cadence

  Change from baseline in gait cadence during each intervention condition (3 x 10 min walking)

• Coefficient of variation of stride duration

  Change from baseline in coefficient of variation during each intervention condition (3 x 10 min walking)

Study Arms (1)

PD patients

EXPERIMENTAL

See inclusion criteria in the right section. See procedures in the the right section.

Other: No cueing versus Haptic cueing versus Auditory cueing during parkinson's disease gait

Interventions

No cueing versus Haptic cueing versus Auditory cueing during parkinson's disease gait OTHER

Patients walked in three conditions in a randomized order. During control condition, patients walked without cueing on a rectangular track of 63.2 meters at their comfortable gait speed. During Auditory Cueing Condition (ACC) patients walked on the same track using auditory cueing by the mean of a smartphone app called Soundbrenner thath deliverered rhythmic auditory stimulations through earphones paced 10% faster than each patient's preferred step frequence. During Haptic Cueing Condition (HCC) patients walked on the same track using haptic cueing by the mean of a vibratory device called Soundbrenner Pulse and attached to each patient's wrist located on their most affected side. The Soundbrenner app on the smartphone was connected to the Soundbrenner Pulse by Bluetooth to deliver rhythmic vibratory stimulations also paced 10% faster than each patient's preferred step frequence, the same frequence as during ACC.

PD patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic PD according to the UK Brain Bank Criteria
• modified Hoehn \& Yahr scale \<= 3
• Mini-Mental State Examination \> 24/30
• Ability to walk 256 consecutive strides

You may not qualify if:

• Other pathology interacting with gait
• Significant hearing problems not allowing to hear the auditory cueing
• Significant somatosensory problems not allowing to feel the haptic cueing on the skin

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Lheureux A, Lejeune T, Doncev I, Jeanne A, Stoquart G. Comparison of the effects of rhythmic vibrotactile stimulations and rhythmic auditory stimulations on Parkinson's disease patients' gait variability: a pilot study. Acta Neurol Belg. 2024 Feb;124(1):161-168. doi: 10.1007/s13760-023-02360-5. Epub 2023 Aug 19.

  PMID: 37597161 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

• Thierry Lejeune, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of patients underwent all experimental conditions once

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: March 30, 2023
• Study Start: January 1, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No particular time frame
• Access Criteria: If asked : alexis.lheureux@uclouvain.be

Locations

BE (2)