Proof of Concept BeatPark (BEATPARK 2)
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auto rehabilitation program of gait with Beat Health device.
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with parkinson's disease
Arm Description
Patients with parkinson's disease
Outcomes
Primary Outcome Measures
Percentage of time of use of the BeatHealth device compared to the prescribed schedule
measured automatically by Beathealth device
Secondary Outcome Measures
Auto-evalation of the number of falls reported by the patient on a daily agenda
self reported in a diary
Full Information
NCT ID
NCT02647242
First Posted
January 5, 2016
Last Updated
December 8, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier, University Ghent, Tecnalia, National University of Ireland, Maynooth
1. Study Identification
Unique Protocol Identification Number
NCT02647242
Brief Title
Proof of Concept BeatPark
Acronym
BEATPARK 2
Official Title
Pilot Study on Feasibility and Safety of a Gait Auto-rehabilitation Program by Rhythmic Auditory Cueing Delivered by BeatHealth in Patients With Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Inclusion of the Last patient
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
August 5, 2016 (Actual)
Study Completion Date
August 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier, University Ghent, Tecnalia, National University of Ireland, Maynooth
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Objectives Main goal: To evaluate the observance of the use of BeatHealth device in gait auto-rehabilitation program in patients with PD.
Secondary objectives :
To evaluate safety by the number of falls
To evaluate tolerance by the evaluation of pain and fatigue
To evaluate the expected improvement on gate and quality of life essentialy
To identify predictive factors associated with a good response to the program
To evaluate the technical feasibility.
Methods Design : prospective and descriptive study Population : 60 patients with PD Inclusion criteria : PD diagnosed according the international criteria form the United Kingdom Parkinson's Disease Society Brain Bank ; gait disorder identified by the neurologist or the rehabilitation doktor ; to be able to work 30 minutes consecutively and without technical support Non inclusion criteria : signs for atypical parkinsonism
Main evaluation criteria:
Percentage of time of use of the BeatHealth device compared to the prescribed schedule (30 minutes of walk, 5 times a week during four weeks : 10 hours for the complete study) .
Secondary evaluation criteria :
n°1 - Auto-evalation of the number of falls reported by the patient on a daily agenda before and during the rehabilitation program.
n°2 - Auto-evalation of pain with a visual analogic scale on a daily agenda before and during the rehabilitation program.
n°3 - (a) gait functional capabilities; (b) spatio-temporal parameters of gait; (c) motot severity of the disease(d) balance ; (e) quality of life ; (f) psychopathological evaluations (g) auditory-sensori-motor and timing capabilities (h) sleep.
n°4 - Numbers of correct connections to the program, number of errors of manipulations, number of phone calls for help.
Statistical analysis : In the randomized control study on 21 patients from Martin et al. (2015) evaluating a rehabilitation programm on rythmic auditory cueing by metronome in patients with PD wiht fall potential, program observance was 83% according to self evaluation by the patients. In our study , to estimate this percentage of about 80% with an accuracy of ± 10% (interval of 20%) with a confidance interval of 95, the number of subjects to include is 60.
Main statistical analysis : in order to evaluate the observance of the BeatHealth device, the percentage of the time of use conpared to the prescribed time (10 hours in total)
Program schedule :
Number of visits : 3 Inclusion period : 7 months Follow-up : 2 weeks (from the inclusion to the beginning of the program) + 4 weeks (program) Calendar of the study : january 2016 - october 2016
Content of the visites :
V0=Inclusion / identification of the favorite musical genres of the patient / Explanation and delivery of the agenda.
V1=
Evalutation criteria
Information and training to the BeatHealth device use (sensors, smartphone use, connexion to the cloud for the transfer of the results)
Operating instructions delivery
Explanation of the rehabilitation program (number of sessions, duration, place…)
Communication of the contact details of the maintenance operator V2= identical to V1 (except for predictive factors).
Description of the intervention 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with parkinson's disease
Arm Type
Experimental
Arm Description
Patients with parkinson's disease
Intervention Type
Behavioral
Intervention Name(s)
Auto rehabilitation program of gait with Beat Health device.
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of time of use of the BeatHealth device compared to the prescribed schedule
Description
measured automatically by Beathealth device
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Auto-evalation of the number of falls reported by the patient on a daily agenda
Description
self reported in a diary
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
33981279
Citation
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.
Results Reference
derived
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Proof of Concept BeatPark
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