Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05794542 |
| Other study ID # |
321744 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 28, 2023 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
University of Leeds |
| Contact |
Rory O'Connor, MD |
| Phone |
01133922615 |
| Email |
medrjo[@]leeds.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Parkinson's disease is a progressive neurological condition which affects more than 145,000
people in the United Kingdom (UK) today. The main symptoms are tremor (uncontrolled shaking),
slowness of movement and difficulty starting movements (termed 'freezing'). Daily exercise is
recommended to help with these symptoms.
Rehabilitation can help to maintain a person's balance, ability to walk and help to prevent
falls. This can allow people living with Parkinson's to maintain their independence for
longer. Rehabilitation is usually carried out at face-to-face appointments in outpatient
departments in hospitals.
STROLLL (www.strolll.co) is a company that have created a programme of activities called Cue
X, to be used on augmented reality glasses. Augmented reality glasses merge computer
generated images and sounds with the real world. Cue X has been created specifically to help
people with Parkinson's.
We are aiming to recruit 50 participants through referrals from specialist doctors, nurses
and physiotherapists in Leeds Teaching Hospitals National Health Service (NHS) Trust. We will
ask these health care professionals to give potential participants an information sheet
outlining the project. A more detailed participant information sheet will be sent by post or
email to those interested.
There will be an initial hospital appointment where written consent will be asked for and an
initial assessment completed. Participants will do a personalised, daily rehabilitation
programme using Cue X on augmented reality glasses for 6 weeks at home (monitored remotely by
a physiotherapist). A final assessment and review will be done in hospital.
The purpose of this project is to see if people with Parkinson's can use the glasses and do
exercises in their own homes. Benefits could include fewer trips to the hospital for
appointments and a more engaging way of participating in rehabilitation.
If successful, this could lead further research into this technology as a new way of
delivering rehabilitation.
Description:
Parkinson's disease is a condition that affects the brain. It is the world's fastest growing
neurological condition which affects more than 145,000 people in the United Kingdom (UK)
today. No one knows exactly why the condition develops and there is currently no cure for
Parkinson's.
The symptoms associated with Parkinson's are usually mild at first, but can become worse over
time. The main symptoms are tremor (uncontrolled shaking), slowness of movement and
difficulty starting movements. People with Parkinson's often have problems with walking and
balance because of these. This can make normal daily activities more difficult.
It is generally recommended that adults are physically active every day to reduce the effects
of sedentary behaviour. UK Department of Health and Social Care guidelines for the adult
population recommend 150 minutes of moderate intensity physical activity (equivalent to 30
minutes per day, 5 days a week) or 75 minutes of vigorous intensity physical activity a week
(gov.uk, 2019). This is no different for people living with Parkinson's. Indeed, people
living with Parkinson's are encouraged to engage in a daily exercise programme to maintain
their mobility, independence, and quality of life. However, it can be difficult to do
exercises because of the disabling symptoms affecting movement. In addition, as gait and
balance ability deteriorate, and the fear of falls increases, maintaining an exercise
programme becomes more difficult, leading to being less able to do everyday activities and
declining quality of life.
Rehabilitation can help people living with Parkinson's to maintain their mobility and
independence, as well as assisting in preventing falls. People usually attend outpatient
appointments with a specialist rehabilitation team for assessment and are commenced on a
treatment programme of advice, exercises and activities. People are reviewed regularly at
face-to-face appointments, with treatment plans adjusted as needed.
One particular problem that many people report with their mobility is 'freezing' when walking
(termed 'freezing of gait' or FoG). This is when a person stops and is unable to take their
next step. Previous research has shown that there are ways to help people when they freeze
using visual or auditory cues to provide 'prompts' to take the next step. For example,
putting taped lines on the floor to step over, a light on a walking stick or listening to the
beat of a metronome. Most of the existing technology relies on someone else being present,
carrying a walking aid or the lines being in fixed places on the floor.
A company called Strolll have created a digital programme specifically for people living with
Parkinson's. It is called Cue X and is used with augmented (mixed) reality glasses. These
glasses are similar to virtual reality glasses except you can see the real world around you
with digital images overlain. The Cue X software is used on two existing proprietary devices,
the Microsoft HoloLens and the Magic Leap.
The Cue X software used provides access to visual and audio cueing, with the potential for
haptic (tactile) cues in the future, in a single wearable device. For each modality, there is
a library of games which utilise cues. The cue-assisted gait and balance exercises that
underpin the games can be selected to form a rehabilitation programme personalised and
adapted to each user aiming to maximise and maintain the positive effect on gait and balance
over time. The Cue X supports independent rehabilitation, delivered in augmented reality, to
enable people with Parkinson's to participate in exercises without a healthcare professional
present, where previously without cueing, walking and balance training would not be possible.
Augmented reality rehabilitation using Cue X has the potential to deliver engaging exercise
treatments that can be completed by a person independently at home. This could reduce
outpatient face-to-face contact time for staff and patients, while improving experiences,
accessibility and treatment outcomes.
