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Parkinson DiseaseNCT05211687

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

An observational study of Parkinson Disease, run by University of Haifa at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Smart-home for freezing of gait
How many people
30 participants
Where
1 siteIsrael
Study dates
12 Dec 2021to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Galit Yogev-Seligmann, PhD contact

+972-4-8288390

galit.yogev@gmail.com

Naomi Josman, PhD contact

njosman@univ.haifa.ac.il

Israel1 site, 1 recruiting

  • Galit Yogev-Seligmann

    Haifa, Please Select..., 3498838

    Galit Yogev-Seligmann, +972-48288390, galit.yogev@gmail.com

    Recruiting

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Smart-home for freezing of gait
Keywords
parkinson's disease, Freezing of gait, Smart-home
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart-home for freezing of gaitOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 1 year

  2. 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.

    Measured: Through study completion, an average of 1 year

  3. Feasibility and participants' satisfaction semi-structured interview

    Following the walking session, participants answered questions in a semi-structured interview:

    1. Did you see the light stripes clearly? (Yes/no)
    2. Did you experience any discomfort while walking over the stripes? For example, did you feel dazzled?
    3. Did you feel any change in your walking while using the light stripes? (Yes/no)
    4. If you did feel any change, can you describe it in your own words?
    5. 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)
    6. 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
    7. Would you like to have such technology installed at your home?
    8. If, yes, which kind of cues would you prefer (light stripe/ metronome)?
    9. Do you have any suggestion for improvement?

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start12 Dec 2021
  3. Primary completion30 Mar 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211687
Sponsor's protocol ID
GALITYS
Status last verified
May 2022
First submitted
2 Jan 2022
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 19660949

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

  • 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.

    PubMed 36658571

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by University of Haifa at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Galit Yogev-Seligmann, PhD (+972-4-8288390, galit.yogev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of smart-home technology on step length (cm) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05211687, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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Clinical Trial NCT05211687 | AzTrials