Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
- Conditions
- Parkinson Disease
- Interventions
- Device: Parkinson HolterDiagnostic Test: Motor fluctuations diaryOther: Traditional clinical practice
- Registration Number
- NCT04176302
- Lead Sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Brief Summary
When Parkinson Disease is mild, it responds well to treatment with drugs (L-Dopa and dopamine antagonists). However, as the disease progresses, the effect of the drugs diminishes and lasts for a shorter time (wearing-off), which require physicians to progressively increase and/or break up the dosage of dopamine drugs, to control symptoms over the course of the entire day. Despite this, most patients present motor fluctuations after 10 years. These fluctuations consist of changes between what are known as Off periods, when the medication does not produce an effect and mobility is hindered, and On periods when patients can move smoothly, with the medication producing its best effect.
The timeline of these motor fluctuations over the course of the day and also on different days is very valuable to precisely adjust the medication. Nevertheless, neurologists do not currently have detailed information on the timeline of the symptoms of their patients, which means that they have serious difficulties to obtain good results with the adjustment of medication. Currently, the neurologist's information on the time progression of the motor fluctuations is drawn from what the patient indicates in the office visit, or in the best case, from diaries that the patient fills out at home, periodically (e.g. every hour) noting the motor state (On or Off). Although the latter method is still the gold standard in research and in care, it has serious limitations, because patients often forget to record the information (especially when they are in Off), many do not recognize their motor states well, and few can maintain adherence to such a laborious system for more than a few days.
The Parkinson Holter (STAT-ON ®) is a wearable device, which objectively measures and records the motor fluctuations of the patients. It does not require intervention by the patient, and can, therefore, be used in daily life, long term if necessary. However, the concept that detailed knowledge of motor fluctuations of patients will lead to better control of the disease, thanks to optimisation of the therapeutic regimen, is still a hypothesis. To demonstrate or refute this hypothesis, we are now conducting a clinical trial, with this medical device, to study the clinical effectiveness in patients with moderate Parkinson's disease and motor fluctuations. This trial will show whether using the Parkinson Holter is better than the clinical interview used in traditional clinical practice (primary objective), and whether it is not inferior to the On-Off diary recorded by the patients at home (exploratory objective)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- Ideopathic Parkinson's Disease
- Disease in the moderate-severe phase (Hoehn & Yahr ≥ 2 en Off)
- Motor fluctuations (with at least 2h/day in Off)
- Agree to participate voluntarily and will sign a written consent form
- Incapable of walking independently or H&Y=5
- Participating in another clinical trial
- Patients with acute intercurrent disease
- Psychiatric or cognitive disorders that prevent collaboration (MMSE <24)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parkinson Holter Parkinson Holter The neurologists in the study will receive information from the Parkinson Holter (device being studied) Parkinson's diary Motor fluctuations diary The neurologists in the study will receive information from a motor fluctuations diary Traditional clinical practice Traditional clinical practice The neurologists in the study will receive no additional information other than what is obtained during the visit
- Primary Outcome Measures
Name Time Method Daily time in Off 7 days Changes from baseline to last visit in daily hours in Off
- Secondary Outcome Measures
Name Time Method Reported quality of life 1 month Changes from baseline to last visit in quality of life, assessed by menas of Parkinson's Disease Questionnaire-39
System usability: System Usability Scale 7 days Usability of the system will be assessed by System Usability Scale (SUS)
Motor complications 6 months Changes from baseline to last visit in motor complications, assessed by means of Unified Parkinson's Disease Rating Scale - part IV
Change of presence and severity of freezing of gait episodes 7 days Changes from baseline to last visit in the number and severity of freezing of gait episodes, assessed by means of Freezing of Gait Questionnaire
Number of clinical contacts 6 months Number of patient visits and telephone controls to adjust medication
Patient's adherence to the MF measurement system 7 days Total hour/days with information registered.
Number of therapeutic changes. 6 months Number of therapeutic changes done to improve symptoms.
Daily time in On 7 days Changes from baseline to last visit in daily hours in On
User satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology 7 days Physician and patient satisfaction with the Parkinson Holter will be assessed by means of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Activities of Daily Living 6 months Changes from baseline to last visit in dependence for Activities of Daily Living assessed by means of Unified Parkinson's Disease Rating Scale - part II
Trial Locations
- Locations (43)
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Univesitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, Guipúzkoa, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General de Elche
🇪🇸Alicante, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Consorci Sanitari del Maresme. Hospital de Mataró
🇪🇸Mataró, Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital General de l'Hospitalet. CS Integral
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Moisès Broggi - CS Integral
🇪🇸Barcelona, Spain
Terapia Integral UParkinson, SL
🇪🇸Barcelona, Spain
Hospital Universitario Lucus Augustí
🇪🇸Lugo, Galicia, Spain
Hospital General Parc Sanitari Sant Joan de Déu
🇪🇸Sant Boi De Llobregat, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Royo de Vilanova
🇪🇸Zaragoza, Spain
Hospital Universitario Infanta Sofía
🇪🇸San Sebastián De Los Reyes, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario del Henares
🇪🇸Madrid, Spain
Hospital Universitario La Moraleja
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat Del Vallès, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital de Llíria
🇪🇸Valencia, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Sanitas CIMA
🇪🇸Barcelona, Spain
Hospital General La Mancha-Centro, Alcázar de San Juan
🇪🇸Alcázar De San Juan, Ciudad Real, Spain
Hospital Universitari Mútua Terrassa
🇪🇸Terrassa, Barcelona, Spain
Consorci Sanitari de l'Alt Penedès i Garraf
🇪🇸Vilafranca Del Penedès, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitari dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain