Proof of Concept BeatPark (BEATPARK 2)

December 8, 2021 updated by: University Hospital, Montpellier

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 :

  1. To evaluate safety by the number of falls
  2. To evaluate tolerance by the evaluation of pain and fatigue
  3. To evaluate the expected improvement on gate and quality of life essentialy
  4. To identify predictive factors associated with a good response to the program

  5. 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

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with parkinson's disease
Behavioral: Auto rehabilitation program of gait with Beat Health device.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time of use of the BeatHealth device compared to the prescribed schedule
Time Frame: 4 weeks
measured automatically by Beathealth device
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auto-evalation of the number of falls reported by the patient on a daily agenda
Time Frame: 4 weeks
self reported in a diary
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

University Ghent
National University of Ireland, Maynooth
Université Montpellier
Tecnalia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 24, 2015

Primary Completion (ACTUAL)

August 5, 2016

Study Completion (ACTUAL)

August 5, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (ESTIMATE)

January 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9193-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Auto rehabilitation program of gait with Beat Health device.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe