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.
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.
- Type of treatment
- Lifestyle or therapy programme
- 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 :
- 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
- Conditions
- Parkinson's Disease
- 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 group | Role | What they receive |
|---|---|---|
| Patients with parkinson's disease | Experimental | Patients 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.
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)
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.
- First posted6 Jan 2016 (estimated)
- Study start24 Nov 2015
- Primary completion5 Aug 2016
- Study completion5 Aug 2016
Why it stopped: Inclusion of the Last patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier, University Ghent, Tecnalia, National University of Ireland, Maynooth
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02647242
- Acronym / sponsor ID
- BEATPARK 2 / UF 9193-4
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion of the Last patient
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier, University Ghent, Tecnalia, National University of Ireland, Maynooth
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with parkinson's disease | Experimental | Behavioral: Auto rehabilitation program of gait with Beat Health device.Patients with parkinson's disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Patients with parkinson's disease |
Primary outcome
Percentage of time of use of the BeatHealth device compared to the prescribed schedule
Time frame: 4 weeks
measured automatically by Beathealth device
1 secondary outcome
Auto-evalation of the number of falls reported by the patient on a daily agenda
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Inclusion of the Last patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 33981279Cochen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.