Cue X as a Treatment for People With Parkinson's Disease

NCT05794542 | Completed

• 1 other identifier: 321744
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• EQ-5D-5L (This is the registered name of the outcome measure)

  5-level EuroQoL-5 dimension: health related quality of life assessment

  At 6 weeks: on completion of the intervention

Secondary Outcomes (2)

• The Parkinson's Disease Questionnaire (PDQ-39)

  At 6 weeks: on completion of the intervention

• Lindop Parkinson's Assessment Scale

  At 6 weeks: on completion of the intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Use of Cue X intervention

Device: Cue X

Interventions

Cue X DEVICE

Cue X 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 devices, the Microsoft HoloLens and the Magic Leap.

Intervention

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years Confirmed Parkinson's diagnosis Under the care of a consultant or Parkinson's specialist nurse in Leeds. Able to walk indoors with or without a walking aid

You may not qualify if:

• Age \< 18 years Skin condition on head or face that prevents wearing the headset Cognitive impairment causing inability to consent Unable to walk at any time Severe visual impairment resulting in inability to see the augmented reality information Epilepsy Mental health condition causing hallucinations

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

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

• Rory O'Connor, MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charterhouse Professor of Rehabilitation Medicine

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: April 3, 2023
• Study Start: October 28, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)