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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211687
• Other study ID #: GALITYS
• Status: Recruiting
• Start date: December 12, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: University of Haifa
• Contact: Galit Yogev-Seligmann, PhD
• Phone: +972-4-8288390
• Email: galit.yogev[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Smart-home for freezing of gait
A projector, Kinect camera and computer are located 2 meters from the walking area. Participants walk nine times back and forth on the walking track, in each of three walking conditions: Baseline: participants walk in a comfortable pace. The walking track consist a rectangle created by a white light projected on the floor. Based on in this walking condition, step width and cadence are calculated to determine the individual parameters of the cueing. Light-stripes: The walking area consist of 4-5 white light-stripes. Space between the stripes is 110% of the participant step length. Participants are instructed to walk over the stripes. Metronome: The walking track consist of a rectangle created by a white light projected on the floor, and in addition metronome beats are delivered by the computer. Beats frequency are 90% of the cadence. Participants are instructed to match their steps to the metronome beats. Each walking condition up to 90 seconds.

Locations

Country	Name	City	State
Israel	Galit Yogev-Seligmann	Haifa	Please Select...

Sponsors (3)

Lead Sponsor	Collaborator
University of Haifa	Hebrew University of Jerusalem, Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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