An interventional study of EQUISTASI in Freezing of Gait and Parkinson Disease, sponsored by ASST Gaetano Pini-CTO. Terminated at 1 site in Italy. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by ASST Gaetano Pini-CTO · Not applicable, Interventional, and Treatment
Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →ASST Gaetano Pini-CTO is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
Device: EQUISTASI
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
Freezing of gait questionnaire severity
Change in freezing of gait questionnaire score
Time frame: 4 weeks
Gait and Falls Questionnaire (GFQ) score
Change in the GFQ score
Time frame: 4 weeks
39-item Parkinson's Disease Questionnaire
Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire
Time frame: 4 weeks
Falls
Number of falls recorded during the intervention period
Time frame: 4 weeks
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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ASST Gaetano Pini-CTO