Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000139178
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
30/01/2019
Date last updated
24/01/2020
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Video self-modelling using a virtual reality headset for managing freezing of gait in people with Parkinson’s disease: a feasibility study
Scientific title
Tailoring an immersive 180 degree video self-modelling virtual reality solution for managing freezing of gait in people with Parkinson’s disease: a pilot study
Secondary ID [1] 296500 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 310444 0
Freezing of gait 310446 0
Condition category
Condition code
Neurological 309162 309162 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 309163 309163 0 0
Physiotherapy
Physical Medicine / Rehabilitation 309164 309164 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive up to 8 home visits over 6 weeks. It is estimated that participants will receive 1-2 home visits per week, with each visit lasting approximately an hour.

In home visits 1-2, the participant will identify situations in the home where freezing of gait (FOG) is “troublesome”. Managing FOG in these situations will form participant-directed goals. A trained physiotherapist will then assess each participant’s motor, cognitive, emotional and environmental triggers of FOG in these situations. The identification of FOG triggers and development of suitable movement strategies will be guided by the participant’s responses on the Characterising Freezing of Gait Questionnaire. The physiotherapist and the participant will work collaboratively to determine the best movement strategy to overcome FOG in each situation where FOG was triggered. The movement strategy may be supported by self-prompting (e.g. counting) or external auditory cues (e.g. metronome), or visual cues (e.g. tape on the ground). The participant will be filmed in his/her own home using a 180 degree camera performing his/her best movement strategy to overcome FOG in one of the situations previously identified. The video will be edited to show the participant’s best performance repeated 3 times (approximately 1 min in duration).

At home visits 3-4, the physiotherapist will deliver a virtual reality (VR) headset with the uploaded personal video of each participant. The physiotherapist will teach the participant how to operate the VR headset. The participant will view his/her own best movement strategy in his/her own home repetitively in a seated position. The participant will be asked to view the video x2/day (approximately 5 mins in duration per viewing). Each participant will also be asked to physically practise his/her best movement strategy in his/her home (approximately 10 mins in duration) x1/day after one of the daily viewings. The twice-daily viewing and once-daily physical practice will be performed 5 days/week.

At home visits 5-6, the physiotherapist will assess participants’ progress with their first movement strategy. The physiotherapist will then film the participant performing a second movement strategy to overcome FOG. It is anticipated that the second video may be the same task in a different environment, same task with increased complexity, or a different task altogether. The second video will be edited to show the participant’s best performance 3 times. The physiotherapist will deliver the second video and participants will view the second video using the VR headset x2/day and perform physical practice x1/day, 4 days/week. In addition, the participant will continue to view the first video of the first movement strategy using the VR headset x2/day and perform physical practice x1/day, 1 day/week.

A detailed intervention protocol will be developed and monitored to ensure fidelity in the delivery of the intervention. Assessment of adherence to the intervention will be based on the number and duration of home visits. Participants will be also be asked to record his/her video viewings and physical practice using a logbook.

Baseline measures will be completed within one week prior to the start of the intervention (week 1). The 6 weeks intervention will be delivered between week 2 to 7. Post-intervention measures will completed within one week of intervention completion (week 8).
Intervention code [1] 312935 0
Rehabilitation
Intervention code [2] 313399 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308137 0
Feasibility of the intervention, assessed by the evaluation of:
1. Recruitment rates - assessed by evaluating the number of participants screened, number eligible for inclusion and number who consent to participate.

2. Retention rates - assessed by evaluating the number of participants who consent to participate and number who completed the study

3. Adherence to the intervention - participants will be required to complete a logbook recording the amount of their video viewings and physical practice

4. Adverse events associated with the intervention - participants will be required to record and report any adverse events (e.g. falls and injuries sustained as a result of the intervention)
Timepoint [1] 308137 0
After the 6 weeks intervention (week 8)
Primary outcome [2] 308138 0
Acceptability of the intervention, assessed by the evaluation of:
1. Modified Players Experience of Need Satisfaction Questionnaire (Ryan et al., Motiv Emot, 2006)

2. Semi-structured interview to explore the participant’s experience of the intervention. Interviews are expected to last less than 60 minutes, will be audio-recorded and transcribed for analysis.
Timepoint [2] 308138 0
After the 6 weeks intervention (week 8)
Secondary outcome [1] 354066 0
Ziegler test of FOG (Ziegler et al., Mov Disord, 2010)
Timepoint [1] 354066 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [2] 365631 0
Freezing while turning test (Mancini et al., Neuroscience, 2017)
Timepoint [2] 365631 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [3] 365632 0
New Freezing of Gait Questionnaire (Nieuwboer et al., Gait Posture, 2009)
Timepoint [3] 365632 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [4] 365633 0
Characterizing Freezing of Gait Questionnaire (Ehgoetz Martens et al., Mov Disord, 2018)
Timepoint [4] 365633 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [5] 365634 0
Timed Up and Go test (Podsiadlo and Richardson, J Am Geriatr Soc, 1991)
Timepoint [5] 365634 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [6] 365635 0
Goal Attainment Scale (Turner-Stokes L, Clin Rehabil, 2009)
Timepoint [6] 365635 0
Start of the intervention (week 2) and after the 6 weeks intervention (week 8)
Secondary outcome [7] 365636 0
Parkinson Anxiety Scale (Leentjens et al., Mov Disord, 2014)
Timepoint [7] 365636 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [8] 365637 0
Changes in biomechanical variables will be measured using accelerometers (Opals by APDM Inc.) worn during the Ziegler test for FOG, Freezing while turning test and Timed Up and Go test.

The following biomechanical variables will be collected:
1. Ziegler test of FOG - 3D acceleration, angular velocity, time taken to complete the test.

2. Freezing while turning test - 3D acceleration, angular velocity, number of turns, average peak speed of turns completed, average jerkiness of the turns, freezing ratio (based on analysis of power spectral densities) (Mancini et al., Neuroscience, 2017)

3. Timed Up and Go test - 3D acceleration, angular velocity, step length, number of steps
Timepoint [8] 365637 0
Baseline (week 1) and after the 6 weeks intervention (week 8)
Secondary outcome [9] 365971 0
Percentage of time frozen using video analysis of the Ziegler test of FOG, Freezing while Turning test and Timed Up and Go test. (Ehgoetz Martens et al., Mov Disord, 2018)
Timepoint [9] 365971 0
Baseline (week 1) and after the 6 weeks intervention (week 8)

Eligibility
Key inclusion criteria
Diagnosis of idiopathic Parkinson’s disease
Presence of freezing of gait (score of more than or equal to 1 on Question 2 and score of more than or equal to 2 on Question 4 of the New Freezing of Gait Questionnaire)
Stable dopaminergic medication regimen for at least 4 weeks prior to commencement of study
Able to walk at least 10 metres independently with or without a walking aid
Lives in the greater Sydney metropolitan area
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical conditions which would preclude or interfere with study safety and conduct (e.g., unstable cardiovascular disease, neurological condition other than Parkinson's disease)
Cognitive impairment (Mini Mental State Examination Assessment <24)
Less than 6 months post deep brain stimulation surgery
Significant head tremor or motion sickness limiting ability to use a virtual reality headset

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility and secondary outcomes will be explored using descriptive statistics. The acceptability of the intervention will be explored through analysis of the Players Experience of Need Satisfaction Questionnaire and the interview data. Interview data will be audio-recorded, transcribed verbatim, coded and emerging themes explored. NVivo10 will be used to assist in the process of data analysis. Content and thematic analysis will guide interpretation of the data (first via initial coding, followed by focused coding and then theoretical coding). Secondary outcome data will be used to inform the sample size for a randomised controlled trial of the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/02/2019
Actual
2/04/2019
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
3/06/2020
Actual
Sample size
Target
12
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301203 0
University
Name [1] 301203 0
The University of Sydney
Country [1] 301203 0
Australia
Funding source category [2] 301204 0
Government body
Name [2] 301204 0
Australian Government Research Training Program Scholarship
Country [2] 301204 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Discipline of Physiotherapy
School of Health Sciences
Faculty of Medicine and Health
The University of Sydney
PO BOX 170 Lidcombe
NSW 1825
Country
Australia
Secondary sponsor category [1] 301342 0
None
Name [1] 301342 0
Address [1] 301342 0
Country [1] 301342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301839 0
The University of Sydney Human Research Ethics Commiittee
Ethics committee address [1] 301839 0
Research Integrity and Ethics Administration
Level 3, Administration Building (F23)
University of Sydney
NSW 2006
Ethics committee country [1] 301839 0
Australia
Date submitted for ethics approval [1] 301839 0
22/10/2018
Approval date [1] 301839 0
19/12/2018
Ethics approval number [1] 301839 0
2018/893

Summary
Brief summary
Freezing of gait commonly affects people with Parkinson’s disease and is known to impair mobility, increase falls risks, and reduce quality of life. The pathophysiology behind freezing of gait remains poorly understood but there is growing evidence to suggest a complex relationship between motor and non-motor factors such as cognition, mood, and environment.

Pharmacological treatment is commonly offered as an intervention for freezing of gait. However, freezing of gait may persist despite optimal pharmacological intervention, especially with increased disease duration and severity.

Non-pharmacological and non-surgical interventions for freezing of gait such as action observation show promise as an effective intervention to reduce freezing of gait. To date, the approach that has been tested involves: (i) the person with FOG watching video clips of an actor (without Parkinson’s disease) performing generic movement strategies to reduce freezing of gait in a clinical setting, followed by (ii) physically practising the movement strategies.

The intervention that is proposed in this study is a 180 degree video self-modelling intervention using an immersive virtual reality headset, whereby the person with Parkinson’s disease observes videos of his/her own best movement strategies for preventing or overcoming freezing of gait, performed in his/her own home environment. The personalised movement strategies will be based on assessment of the individual’s motor, cognitive, emotional and environmental FOG triggers and exploration of appropriate and acceptable movement strategies for the person by a trained physiotherapist. Participants will watch their videos repeatedly (while seated), with physical practice performed separately in the context of everyday tasks.

This pilot study aims to determine the feasibility and acceptability of a video self-modelling intervention using an immersive virtual reality headset for managing freezing of gait in people with Parkinson’s disease. In addition, it will evaluate the impact of the intervention on freezing of gait and on movement strategies used during freezing of gait testing. The project will provide the proof-of-concept evidence required to secure large grant funding for a randomised controlled trial to evaluate the effectiveness of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88282 0
Prof Colleen Canning
Address 88282 0
Discipline of Physiotherapy
School of Health Sciences
Faculty of Medicine and Health
The University of Sydney
PO Box 170 Lidcombe
NSW 1825
Australia
Country 88282 0
Australia
Phone 88282 0
+61 2 9351 9263
Fax 88282 0
Email 88282 0
[email protected]
Contact person for public queries
Name 88283 0
Ms Lina Goh
Address 88283 0
Discipline of Physiotherapy
School of Health Sciences
Faculty of Medicine and Health
The University of Sydney
PO Box 170 Lidcombe
NSW 1825
Australia
Country 88283 0
Australia
Phone 88283 0
+61 2 9351 9010
Fax 88283 0
Email 88283 0
[email protected]
Contact person for scientific queries
Name 88284 0
Ms Lina Goh
Address 88284 0
Discipline of Physiotherapy
School of Health Sciences
Faculty of Medicine and Health
The University of Sydney
PO Box 170 Lidcombe
NSW 1825
Australia
Country 88284 0
Australia
Phone 88284 0
+61 2 9351 9010
Fax 88284 0
Email 88284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.