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Parkinson's DiseaseBEATPARK 2NCT02647242

Proof of Concept BeatPark

A study testing Auto rehabilitation program of gait with Beat Health device. in people with Parkinson's Disease, run by University Hospital, Montpellier.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Auto rehabilitation program of gait with Beat Health device.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
24 Nov 2015to 5 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

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.

Read the 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
Being tested
Auto rehabilitation program of gait with Beat Health device.
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auto rehabilitation program of gait with Beat Health device.Behavioural

    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 groups in NCT02647242
Study groupRoleWhat they receive
Patients with parkinson's diseaseExperimentalPatients with parkinson's disease
Receives: Behavioral: Auto rehabilitation program of gait with Beat Health device.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time of use of the BeatHealth device compared to the prescribed schedule

    measured automatically by Beathealth device

    Measured: 4 weeks

Secondary outcomes (1)
  1. Auto-evalation of the number of falls reported by the patient on a daily agenda

    self reported in a diary

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study start24 Nov 2015
  3. Primary completion5 Aug 2016
  4. Study completion5 Aug 2016

Why it stopped: Inclusion of the Last patient

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647242
Sponsor's protocol ID
UF 9193-4
Acronym
BEATPARK 2
Status last verified
Dec 2021
First submitted
5 Jan 2016
Last updated
29 Dec 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33981279

Questions about this trial

What is this clinical trial studying?

A study testing Auto rehabilitation program of gait with Beat Health device. in people with Parkinson's Disease, run by University Hospital, Montpellier.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Inclusion of the Last patient). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time of use of the BeatHealth device compared to the prescribed schedule (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647242, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.

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