Clinical trial NCT05211687: Smart Home-based Technology to Promote Functional Mobility Among Individuals With Parkinson's Disease
Official title: Smart Home-based Technology to Promote Functional Mobility Among Individuals With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: parkinson's disease
Freezing of gait
Smart-home
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
name: Technion, Israel Institute of Technology
First posted: 2022-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poeple diagnosed with Parkinson's disease, living in the community

Brief summary: Many patients with Parkinson's disease suffer of gait disorder termed as "freezing of gait" (FOG). non-pharmacological approach such as applying external cues is effective in mitigating FOG events. The aim of this study is to test the feasibility and patients satisfaction from a first stage of technology development, designed to deliver automatically external cues to the patients in their homes.

Detailed description: People with Parkinson's disease (PwP) may experience severe difficulties in mobility that negatively affect their function and Quality of life. Freezing of gait, (FOG) is a brief and sudden inability to initiate walking or move forward, despite an intention to walk. Such episodes are often observed when PwP attempt to turn, cross a narrow space or negotiate obstacles. Rehabilitation interventions for FOG represent the most effective non-pharmacological approach to maintain functional independence and reduce the risk of falls. A key approach is the provision of external cues, defined as sensory stimuli, which facilitate gait initiation and continuation. These external cues are suggested to bypass the dysfunctional movement pathways in the basal ganglia and therefore, are considered effective in alleviating FOG. Cueing can be applied by different modalities; the most common are visual (e.g. spaced lines on the floor) and auditory (e.g. rhythmic metronome beats).

The term smart-home refers to a range of technologies that are designed for and deployed in individual residences, and are equipped with non-invasive, environmental, and physiological sensors. The concept of a "health smart-home" is a variation of smart-home with a focus on assistive technologies to enable the independence and wellness of residents, including the elderly and patients in supervised residences.

In this study, the investigators will be testing the first phase of developing a smart-home technology designed for patients coping with PD to use in their homes and aims to improve gait and assist in prevention of FOG. The aims of this exploratory study are to evaluate the 1) practical feasibility of the technology, 2) patient satisfaction and 3) the effect of the technology on gait. The device was developed by Selfit medical© and included application of light stripes (visual cues) and metronome beats (auditory cues) that are individually adjusted to the participant walking parameters.

Eligibility criteria: Inclusion Criteria:

* Patient is able to walk independently
* The patient report on daily episodes of FOG as indicated by question #2 in the new FOG questionnaire ("How frequently do you experience freezing episodes?").
* Score\>18 on the Telephone Version of the Mini-Mental State Examination (TMMSE)
* Intact hearing and vision by self-declaration

Exclusion criteria

• The patient suffer of any neurological condition other than Parkinson's disease.

Primary outcomes:
measure: Effect of smart-home technology on step length (cm)
timeFrame: through study completion, an average of 1 year
measure: Effect of smart-home technology on step time (sec) are
timeFrame: Through study completion, an average of 1 year
measure: Feasibility and participants' satisfaction semi-structured interview
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Galit Yogev-Seligmann
state: Please Select...
Study officials:
affiliation: University of Haifa
name: Galit Yogev-Seligmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieuwboer A, Rochester L, Herman T, Vandenberghe W, Emil GE, Thomaes T, Giladi N. Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson's disease and their carers. Gait Posture. 2009 Nov;30(4):459-63. doi: 10.1016/j.gaitpost.2009.07.108. Epub 2009 Aug 5.
citation: Keus HSJ, Munneke M, G. M. et al. European Physiotherapy Guidline for Parkinson's Disease. (2014).