Characterize freezing of gait episodes

Trial ID
NCT06519279
Official Title
An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
Goal
Characterize freezing of gait episodes
Status
RECRUITING
Sponsor
Tel-Aviv Sourasky Medical Center
Study Type
OBSERVATIONAL
Enrollment
20 participants
Conditions
PD - Parkinson's Disease
Interventions
Opals, Axivity

Plain-Language Summary

The project aims to improve detection and measurement of freezing of gait, the sudden brief inability to step that many people with Parkinson's experience. It uses small wearable motion sensors called Opal and Axivity to record detailed limb and trunk movement and automatically identify and quantify freezing episodes during clinic tests and in daily life, the sensors only collect movement data and do not interact with levodopa or other drugs, though participants may be asked to briefly delay their morning Parkinson's medication. Adults 18 and older with idiopathic Parkinson's who can walk 10 meters unaided, have no deep brain stimulator, and have had stable Parkinson's meds for at least 4 weeks can join, with those who have freezing needing a score of 1 or more on the New Freezing of Gait Questionnaire; recent major cardiac events, active cancer treatment, certain severe medical or psychiatric conditions, pregnancy, or unwillingness to delay morning meds exclude someone.

Locations

  • Tel Aviv Saurasky Medical Center, Tel Aviv, Israel

Frequently Asked Questions

What is this trial testing?
This trial is studying Opals. The project aims to improve detection and measurement of freezing of gait, the sudden brief inability to step that many people with Parkinson's experience. It uses small wearable motion sensors called Opal and Axivity to record detailed limb and trunk movement and automatically identify and quantify freezing episodes during clinic tests and in daily life, the sensors only collect movement data and do not interact with levodopa or other drugs, though participants may be asked to briefly delay their morning Parkinson's medication. Adults 18 and older with idiopathic Parkinson's who can walk 10 meters unaided, have no deep brain stimulator, and have had stable Parkinson's meds for at least 4 weeks can join, with those who have freezing needing a score of 1 or more on the New Freezing of Gait Questionnaire; recent major cardiac events, active cancer treatment, certain severe medical or psychiatric conditions, pregnancy, or unwillingness to delay morning meds exclude someone.
Who can participate?
Participants must be at least 18 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 1 year and 2 months.

View on ClinicalTrials.gov