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Parkinson DiseaseNCT03214926

Moving Through Glass: An Augmented Reality Device Application for Persons With Parkinson's Disease

A study testing Moving Through Glass intervention in people with Parkinson Disease, run by Syracuse University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recently, Mark Morris Dance Group, and created Moving Through Glass (MTG), a project that was funded by Google, as a portable, round-the-clock extension of the internationally acclaimed Dance for Parkinson's Disease (PD)®. 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?
Moving Through Glass intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
No sites listed yet
Study dates
17 Oct 2016to 28 May 2017
Phase
Interventional
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

Who may be able to join

  • self-reported diagnosis of Parkinson's disease
  • age 18 years or over

Who cannot join

  • Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III> 57
  • Montreal Cognitive Assessment (MOCA)<21,
  • not being able to wear or operate Google Glass.

About this study

Official title: A Pilot Study to Evaluate the Augmented Reality-Based Dance Application on Mobility and Balance of Persons With Parkinson's Disease

Recently, Mark Morris Dance Group, and created Moving Through Glass (MTG), a project that was funded by Google, as a portable, round-the-clock extension of the internationally acclaimed Dance for Parkinson's Disease (PD)®. When a user activates Glass, participants can choose from a variety of different exercises, like "warm me up" or "balance me." Once selected, they see the founder instructors of the Dance for PD® projected in front of them.

As a single site research study at Syracuse University, researchers are conducting the pilot phase of the research project.

The purpose of the study is to investigate the impact of MTG on quality of life and motor functions (i.e. balance, gait, fall efficacy). Participation in the study required three visits to Women's Building in a period of four weeks and about 1-3 hours of the participant's time at each visit. During the first visit, 1 participants reviewed the consent form, completed Montreal Cognitive Assessment (MOCA) and if qualified participated in a face-to-face interview. Participants were given survey package to fill out at home and were given a week to complete all the paperwork. On the second visit, they returned the completed survey package, were given physical assessments and were taught how to use Google Glass. The participants left with Google Glass, log sheet, and survey package. After 3 weeks, participants came to Women's Building for the last visit and the physical assessments were repeated, followed by an exit interview.

Read the detailed description

The common symptoms of Parkinson's disease (PD) include but are not limited to resting tremor, muscular rigidity, and difficulty in initiating movement. These motor impairments, which can negatively impact the fluidity and pacing of movement, can increase the risk people with PD face in their daily activities. Additionally, non-motor symptoms such as apathy and depression can often lead to isolation, potentially reducing physical activity in people with PD.

In 2001, Dance for Parkinson's Disease (DfPD), a collaboration between Brooklyn Parkinson Group (BPG) and Mark Morris Dance Group (MMDG), an internationally known company based in Brooklyn, began providing dance classes for the Parkinson community to train other teachers in the hopes of developing cognitive strategies and to enhance the sense of community and the amount of physical activity in PD population. Since then, positive effects of dance in motor and cognitive functions of people with PD have been reported from several types of dance classes.

While recent research has investigated dance as a therapy for people with Parkinson's disease (PD), there is only one study, to our knowledge, that investigates the use of Google Glass as a portable way for persons with PD to use cued movement as they perform activities of daily living to help temporarily alleviate symptoms such as freezing, initiating movement, and balancing. This qualitative study explored the acceptability of the Google Glass in five participants with PD, as well as their caregivers. The results of this study showed that participants highly favored the voice activation system used to control this technology, especially in comparison to the frustrations expressed using touch screen smart phones. The participants also expressed increased confidence because the Google Glass gave them a sense of independence when going out into public alone. Despite the potential beneficial uses of the Glass, due to the highly complicated menus with multiple applications participants found using the Glass frustrating. Additionally, low number of participants used in this study, very short intervention time, and the lack of quantitative data suggests that further investigation of use of a simplified version of Google Glass in rehabilitation of Parkinson's disease is necessary.

Recently, MMDG created Moving Through Glass (MTG), a project that was funded by Google, as a portable, round-the-clock extension of the internationally acclaimed Dance for PD®. When a user activates Glass, they can choose from a variety of different exercises, like "warm me up" or "balance me." Once selected, they see the founder instructors of the Dance for PD® projected in front of them.

As a single site research study at Syracuse University, researchers will be conducting the pilot phase of the research project. MMDG provided the research team with the three pairs of glasses needed to complete this study. At the end of this study, the glasses will be returned to MMDG. The MTG questionnaire (described in detail in Section 4), provided by MMDG as part of their product development, will also be given to the participants to collect information about the product. MTG questionnaires, including only deidentified, gross data, will be shared with MMDG as a part of product development, not research. Researchers will NOT be reporting our research findings to Google or MMDG.

The purpose of the study is to investigate the impact of MTG on quality of life and motor functions (i.e. balance, gait, fall efficacy). Researchers are trying to answer the following questions:

Purpose #1: What are the Parkinson's disease patients' experiences (constraints, benefits, strategies, etc) related to physical activity?

Purpose #2: What is the participants' perception of using Google Glass during their daily activities? In topics related to:

  • Perceived competence
  • Movement independency
  • Participation in physical activity
  • Participation in social interactions

Participants in this study will be people with Parkinson's disease. Researchers plan to recruit 15 subjects in this project. Due to the limited number of Google Glasses (3 pairs), only 3 participants will go through the study at a given time period. Once recruited, the participants will be expected to make three visits to Women's Building at Syracuse University in a one-month period. On the first visit, researchers will go over the consent form with the participants. Upon signing the forms, participants will be asked to complete the Montreal Cognitive Assessment (MOCA, 10 min). The MOCA is shown to be a highly sensitive cognitive assessment even for mild cognitive impairment and is used widely with Parkinson's population. Researchers will use this assessment to have a cut-off point for the exclusion criteria for the participants who are in a high-risk group for dementia. The optimal cut-off value of 22 is determined on a 30-point scale, with 30 indicating no cognitive problems. The scale is comprised of 7 sub scores that include executive functioning, memory, naming, attention, language, abstraction, and orientation. If the inclusion criteria are met, the participants will also participate in a face-to-face semi-structured interview to explore their perception regarding movement strategies, fear of falling, patterns of physical recreation, perceived benefits, and constraints. This interview will occur before the implementation of the program. The duration of each interview will be between 60 to 75 minutes. This interview will be audio and video recorded. The purpose of video and audio recording of the interviews is to ensure that we capture the essential meaning of participants' experiences.

Once the interviews are completed, the participants will receive a package that includes several questionnaires and surveys.

Being tested
Moving Through Glass intervention
Keywords
Parkinson's disease, Dance, Google Glass, Mobility, Balance
Medical subject headings
Parkinson Disease

What participants receive

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

  • Moving Through Glass interventionDevice

Study groups in NCT03214926
Study groupRoleWhat they receive
Moving Through Glass interventionExperimentalParticipants were asked to use Moving Through Glass (MTG) intervention on Google Glass for at least once a day for 3 weeks. MTG intervention includes 4 difference guided-dance/movement modules for the participants.
Receives: Device: Moving Through Glass intervention

What is being measured

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

  1. Mobility

    To assess the mobility of people with Parkinson's disease. This outcome will be measured using the Mini Balance Evaluations System Test (Mini-BESTest)

    Measured: 3 weeks

Secondary outcomes (8)
  1. Mood

    To assess the depression levels of people with Parkinson's disease. This outcome will be measured using the Becks Depression Inventory (BDI)

    Measured: 3 weeks

  2. Quality of life of Participants

    To assess the quality of life of people with Parkinson's disease. This outcome will be measured using the Parkinson's Disease Quality of Life questionnaire (PDQL)

    Measured: 3 weeks

  3. Google Glass experience-Questionnaire

    To assess the experiences of persons with PD regarding the Google Glass use. This outcome will be measured using the Moving Through Glass questionnaire.

    Measured: 3 weeks

  4. Quantitative measures of the Google Glass experience

    To assess the experiences of persons with PD regarding the Google Glass use. This outcome will be measured using quantitative participant report.

    Measured: 3 weeks

  5. Qualitative measures of the Google Glass experience

    To assess the experiences of persons with PD regarding the Google Glass use. This outcome will be measured using qualitative participant interviews.

    Measured: 3 weeks

  6. Balance-MiniBestTEst

    To assess the balance of people with Parkinson's disease. This outcome will be measured using the Mini Balance Evaluations System Test (Mini-BESTest)

    Measured: 3 weeks

  7. Balance-ABC

    To assess the balance of people with Parkinson's disease. This outcome will be measured using the Activity-specific Balance Confidence scale (ABC)

    Measured: 3 weeks

  8. Physical activity

    To assess the engagement in physical activity of people with Parkinson's disease. This outcome will be measured using the Physical Activity Scale for Elderly (PASE).

    Measured: 3 weeks

Timeline

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

  1. First posted12 Jul 2017
  2. Study start17 Oct 2016
  3. Primary completion28 May 2017
  4. Study completion28 May 2017

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective uncontrolled pilot study
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03214926
Sponsor's protocol ID
16239
Status last verified
Nov 2018
First submitted
7 Jul 2017
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Moving Through Glass intervention in people with Parkinson Disease, run by Syracuse University.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mobility (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Dec 2018.

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Clinical Trial NCT03214926 | AzTrials