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.
Exclusion Criteria:
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