Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05822258

DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units

Led by Rennes University Hospital · Updated on 2024-10-09

20

Participants Needed

1

Research Sites

134 weeks

Total Duration

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AI-Summary

What this Trial Is About

Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. It is defined as a brief and episodic absence or marked reduction in the forward progression of the feet despite the intention to walk. FOG is one of the most disabling symptoms causing a greater risk of falling and a loss of autonomy for these patients. This symptom is little or not dopamine-sensitive and little improved by surgery (deep brain stimulation). Although this symptom is common and debilitating, it is difficult to assess clinically. The objective assessment of the presence and severity of FOG episodes can be done with tests such as the New-Freezing of Gait Questionnaire (N-FOGQ) with however limitations. Indeed, this filmed examination is scored a posteriori and the accumulation of the administration times which makes it difficult to use in routine clinical practice. To overcome these limitations, the use of a diary completed by the patient himself is a simple alternative to assess this symptom, but studies show that patients abandon this practice in the long term and that it is not used by patients with cognitive impairment. Recent advances in miniaturization have made it possible to create light and compact sensors to assess these events objectively. Inertial measurement units have been widely used in the literature to detect FOG episodes. The choice of the detection algorithms are a major issue in the scientific community. To date, due to the heterogeneity of the protocols, no method is currently required as a reference. The objective is to evaluate the accuracy of a new algorithm to detect the number of FOG episodes in Parkinsonian patients. This evaluation will be done on the freeze-inducing walking path.

CONDITIONS

Official Title

DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old
  • Diagnosed with Parkinson's disease according to the United Kingdom Brain Bank criteria
  • Experiencing freezing of gait episodes with a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS II - question 13) score between 1 and 3
  • Able to walk 30 meters independently
  • Affiliated to a social security scheme or beneficiary of such a scheme
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Montreal Cognitive Assessment (MOCA) score below 20 out of 30
  • Other neurological or orthopedic conditions that affect walking
  • Pregnant, giving birth, or breastfeeding women
  • Adults under legal protection or deprived of liberty
  • Receiving psychiatric care or admitted to a health or social establishment for reasons other than research
  • Minors
  • Unable to provide consent
  • Participating in another research study related to balance or walking

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Rennes University Hospital

Rennes, Brittany Region, France, 35000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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