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

NCT ID: NCT05211687

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-12

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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:

1. 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.
2. 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.
3. 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebrew University of Jerusalem

OTHER

Sponsor Role collaborator

Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

University of Haifa

OTHER

Sponsor Role lead

Responsible Party

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Galit Yogev-Seligmann

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Galit Yogev-Seligmann, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

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Galit Yogev-Seligmann

Haifa, Please Select..., Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Galit Yogev-Seligmann, PhD

Role: CONTACT

+972-4-8288390

Naomi Josman, PhD

Role: CONTACT

Facility Contacts

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Galit Yogev-Seligmann

Role: primary

+972-48288390

References

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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.

Reference Type BACKGROUND
PMID: 19660949 (View on PubMed)

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

Reference Type BACKGROUND

Yogev-Seligmann G, Josman N, Bitterman N, Rosenblum S, Naaman S, Gilboa Y. The development of a home-based technology to improve gait in people with Parkinson's disease: a feasibility study. Biomed Eng Online. 2023 Jan 19;22(1):2. doi: 10.1186/s12938-023-01066-2.

Reference Type DERIVED
PMID: 36658571 (View on PubMed)

Other Identifiers

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GALITYS

Identifier Type: -

Identifier Source: org_study_id

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