A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
NCT02302144
Basal Ganglia Diseases, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT02522065
The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating part of the condition. Current methods to evaluate this impairment rely on subjective examinations. The investigators seek to develop an objective assessment of motor deficits by monitoring the participants natural interactions with a keyboard (on a computer or smart device). This approach provides a window to how the brain behaves during typical daily use of these devices, i.e. writing a report, sending an email or any other task performed on a digital device and thus has the potential to be used easily and regularly. (Importantly, the data gathered are non-sensitive and based only on timing information).
PD participants will be recruited during outpatient visits to PD clinics throughout the Madrid metropolitan region. General entry criteria will be those patients who are scheduled to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact on participants' standard clinical management other than by asking the participants to type for 15 minutes at each of the clinic visits, and installing the investigators proprietary software on their home computer. This software will collect keystroke data alone. (None of the actual information about what is being typed will be collected.) The keystroke data collected will be analyzed and compared with standard clinical metrics of therapeutic response, as well as the in-clinic typing data.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Observational
Fundacion Hospital Alcorcón, Alcorcón, Madrid, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24-weeks
A diagnostic table will be computed with all the study subjects. Those subjects with a clinical relevant response to medication (> 4 points in UPDRS - III) will be considered as true positives. Then, the accuracy of the typing test to detect them will be evaluated. For this purpose, the sensitivity, specificity, predictive values and ROC curve of a classification algorithm based on our nQ index will be computed. This will allow us assessing the validity of the test to identify a motor change. detected by the developed algorithm (sensitivity to a motor change).
Time frame: 4,8,16,24-weeks
Correlation (Spearman Rho) analyses between the indices and UPDRS
Time frame: 4,8,16,24-weeks
Correlation (Spearman Rho) between the indices and motor test scores
Time frame: 4,8,16,24-weeks
Correlation (Spearman Rho) between the indices and drug titration measured in L-Dopa equivalent milligrams
Time frame: 4,8,16,24-weeks
Correlation (Spearman Rho) between the indices and the CISI-PD, PDQ-39 and NMSS scales.
Time frame: Week 1
Bland-Altman analyses to evaluate the stability of the indices in different days where the medication was not changed and therefore a change should not be expected
Fundación de investigación HM
Other
Motor Response to Dopaminergic Therapy in a Population of de Novo Parkinson's Disease Cases Quantified Via Typing Analyses - -neuroQWERTY
Acronym: neuroQWERTY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02302144
Basal Ganglia Diseases, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT06646523
Basal Ganglia Diseases, Behavior
Belo Horizonte, Minas Gerais, Brazil
View Trial DetailsNCT05637593
Acoustic Stimulation, Arm
Wuhan, Hubei, China
View Trial DetailsNCT04974034
Akinesia, Basal Ganglia Diseases
Bobigny, Seine Saint Denis, France
View Trial Details