NCT02647242

Brief Summary

Physical activity has demonstrated its beneficial effect on functional capabilities and quality of life in patients with PD. However, the daily physical activity remains limited in these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in patients with PD. The first results of BeatHealth studies have allowed us to identify the best musical stimulation to improve these parameters and the motivation of the patients. The originality of this study is to propose a gait auto-rehabilitation program using BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in PD. Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait parameters, balance, quality of life) will be evaluated.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2016

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

January 5, 2016

Last Update Submit

December 8, 2021

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of time of use of the BeatHealth device compared to the prescribed schedule

    measured automatically by Beathealth device

    4 weeks

Secondary Outcomes (1)

  • Auto-evalation of the number of falls reported by the patient on a daily agenda

    4 weeks

Study Arms (1)

Patients with parkinson's disease

EXPERIMENTAL

Patients with parkinson's disease

Behavioral: Auto rehabilitation program of gait with Beat Health device.

Interventions

Auto rehabilitation program of gait with Beat Health device.BEHAVIORAL

The auto-rehabilitation program will consist in an outside walk, during 5 sessions of 30 minutes per week during 4 weeks with the beatHealth device, delivering the optimal rythmic auditory cueing. The device will associate an Android smartphone, hold at the belt, connected by bluetooth to a headphone and to two sensors strapped to the ankles. The patient will transfer the data collected by BeatHealth to a secured website and will complete the agenda

Patients with parkinson's disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's Disease confirmed by the United Kingdom Parkinson's Disease Society Brain Bank's criteria (Gibb and Lees, 1988; Hughes et al., 1992)
  • Gait disorder confirmed by a neurologist
  • Ability to walk more than 30 minutes without any device as a stick or a walker
  • Stability of the dopaminergic treatment

You may not qualify if:

  • Pregnancy
  • Hearing problems
  • Other neurological disease affecting gait other than PD
  • Other gait disorder whetever the etiology (orthopedic, rheumatologic….)
  • Uncompensated heart or respiratory failure excluding possibility of intensiv rehabilitation.
  • Arguments for atypical parkinsonism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cochen De Cock V, Dotov D, Damm L, Lacombe S, Ihalainen P, Picot MC, Galtier F, Lebrun C, Giordano A, Driss V, Geny C, Garzo A, Hernandez E, Van Dyck E, Leman M, Villing R, Bardy BG, Dalla Bella S. BeatWalk: Personalized Music-Based Gait Rehabilitation in Parkinson's Disease. Front Psychol. 2021 Apr 26;12:655121. doi: 10.3389/fpsyg.2021.655121. eCollection 2021.

    PMID: 33981279DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

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

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 6, 2016

Study Start

November 24, 2015

Primary Completion

August 5, 2016

Study Completion

August 5, 2016

Last Updated

December 29, 2021

Record last verified: 2021-12