Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease

• Sponsor: ASST Gaetano Pini-CTO (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03211260
• Collaborator: Grisons Foundation for Parkinson's Disease (Other), Fondazione IRCCS Policlinico San Matteo di Pavia (Other)
• Enrollment: 42
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Freezing of Gait; Parkinson Disease	Device: EQUISTASI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
• Actual Study Start Date: Dec 11, 2017
• Actual Primary Completion Date: Jul 19, 2019
• Actual Study Completion Date: Jul 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EQUISTASI 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.

Outcome Measures

Primary Outcome Measures

1. Freezing of gait questionnaire severity [4 weeks]

   Change in freezing of gait questionnaire score

Secondary Outcome Measures

1. Gait and Falls Questionnaire (GFQ) score [4 weeks]

   Change in the GFQ score

2. 39-item Parkinson's Disease Questionnaire [4 weeks]

   Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire

3. Falls [4 weeks]

   Number of falls recorded during the intervention period

4. Treatment continuation [4 weeks]

   Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with Parkinson's Disease

• Stable drug therapy response without any change in the 3 months before the study.

• written informed consent

Exclusion Criteria:

• Hoehn-Yahr stage ≥ 4

• Cognitive decline (Mini Mental State Examination <26)

• Systemic illness involving the nervous system

• Diabetes

• Presence of cardiac pacemaker

• Presence of deep brain stimulation

• Presence of severe dysautonomia with marked hypotension

• History or active neoplasia

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Parkinson, ASST Gaetano Pini-CTO	Milano		Italy

Sponsors and Collaborators

• ASST Gaetano Pini-CTO
• Grisons Foundation for Parkinson's Disease
• Fondazione IRCCS Policlinico San Matteo di Pavia

Investigators

• Principal Investigator: Gianni Pezzoli, MD, Centro Parkinson, ASST Gaetano Pini-CTO di Milano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gianni Pezzoli, Principal Investigator, ASST Gaetano Pini-CTO
• ClinicalTrials.gov Identifier: NCT03211260
• Other Study ID Numbers: 319_2017bis
• First Posted: Jul 7, 2017
• Last Update Posted: Sep 12, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gianni Pezzoli, Principal Investigator, ASST Gaetano Pini-CTO: Parkinson Disease; Freezing of gait; Equistasi
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Sep 12, 2019