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

NCT05211687 | Unknown

• 1 other identifier: GALITYS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

parkinson's disease; Freezing of gait; Smart-home

Outcome Measures

Primary Outcomes (3)

• 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: 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?

  through study completion, an average of 1 year

Interventions

Smart-home for freezing of gait OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead
• Hebrew University of Jerusalem: collaborator
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

Galit Yogev-Seligmann

Haifa, Please Select..., 3498838, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 19660949 BACKGROUND

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

  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.

  PMID: 36658571 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Galit Yogev-Seligmann, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galit Yogev-Seligmann, PhD

CONTACT

+972-4-8288390; galit.yogev@gmail.com

Naomi Josman, PhD

CONTACT

njosman@univ.haifa.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: January 27, 2022
• Study Start: December 12, 2021
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)