Smart Home-based Technology to Promote Functional Mobility Among Individuals With Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Smart-home for freezing of gait

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Galit Yogev-Seligmann, PhD; Phone Number: +972-4-8288390; Email: galit.yogev@gmail.com
• Study Contact Backup: Name: Naomi Josman, PhD; Email: njosman@univ.haifa.ac.il

Study Locations

• Israel
  • Please Select...
    • Haifa, Please Select..., Israel, 3498838
      • Recruiting
      • Galit Yogev-Seligmann
      • Contact: Galit Yogev-Seligmann; Phone Number: +972-48288390; Email: galit.yogev@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Poeple diagnosed with Parkinson's disease, living in the community

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of smart-home technology on step length (cm)	Step length (cm) is assessed during the three walking conditions in order to evaluate the effect of the cueing (visual and auditory) applied on gait. Data is collected by the Kinect sensor.	through study completion, an average of 1 year
Effect of smart-home technology on step time (sec) are	Step time (sec) is assessed during the three walking conditions in order to evaluate the effect of the cueing (visual and auditory) applied on gait. Data is collected by the Kinect sensor.	Through study completion, an average of 1 year
Feasibility and participants' satisfaction semi-structured interview	Following the walking session, participants answered questions in a semi-structured interview: Did you see the light stripes clearly? (Yes/no); Did you experience any discomfort while walking over the stripes? For example, did you feel dazzled?; Did you feel any change in your walking while using the light stripes? (Yes/no); If you did feel any change, can you describe it in your own words?; Try to evaluate the magnitude of change in walking using the following visual scale (ranging from -5 to 5 will be presented to the particpants, -5 represent "Much worse", 0 represent "No change" and 5 represent "Much better); Do you think that the light stripes would be effective for avoiding FOGs? Yes/No/ Maybe The same six questions are then asked about the metronome beats; Would you like to have such technology installed at your home?; If, yes, which kind of cues would you prefer (light stripe/ metronome)?; Do you have any suggestion for improvement?	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Technion, Israel Institute of Technology; Hebrew University of Jerusalem
• Investigators: Principal Investigator: Galit Yogev-Seligmann, PhD, University of Haifa

Publications and helpful links

General Publications

• 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.
• Keus HSJ, Munneke M, G. M. et al. European Physiotherapy Guidline for Parkinson's Disease. (2014).

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Freezing of gait; parkinson's disease; Smart-home
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: GALITYS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No