Parkinson's disease Nervous System Diseases
Conditions
Interventions
Design
Two-arm, multi-centre, superiority RCT with two parallel groups (and a 6-month internal pilot).
Setting
Participants will be identified and rehabilitation will be provided in a minimum of 4 NH
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/08/2025: 1. Aged 18 years or older 2. Diagnosed with Parkinson’s disease according to the UK PD Brain Bank criteria (stages 1-4 on the Hoehn and Yahr scale). Stages 1 to 4 reflect varying levels of functional disability as a result of Parkinson's, ranging from minimal/no disability (level 1) to severe disability but still able to walk/stand unassisted (level 4). This will be assessed by the trained physiotherapist. 3. Bothersome gait or balance as self-reported by the individual, while on optimal medication 4. Using a stable dose of medication (i.e., no change within the last 28 days) 5. Ability to walk independently, with or without a walking aid, but not with the assistance of another person. 6. Ability to provide informed consent and comply with the protocol (for example, no additional neurological diseases and/or orthopaedic problems seriously interfering with gait function, insufficient general fitness, or cognitive/communicative inability (as observed by the researcher or clinician) to understand device instructions and participate in the tests Previous inclusion criteria: 1. Aged 18 years or older 2. Diagnosed with Parkinson’s disease according to the UK PD Brain Bank criteria (stages 1-4 on the Hoehn and Yahr scale). Stages 1 to 4 reflect varying levels of functional disability as a result of Parkinson's, ranging from minimal/no disability (level 1) to severe disability but still able to walk/stand unassisted (level 4). This will be assessed by the trained physiotherapist. 3. Bothersome gait or balance as self-reported by the individual 4. Using a stable dose of medication (i.e., no change within the last 28 days) 5. Ability to walk independently, with or without a walking aid, but not with the assistance of another person. 6. Ability to provide informed consent and comply with the protocol (for example, no additional neurological diseases and/or orthopaedic problems seriously interfering with gait function, insufficient general fitness, or 7. Cognitive/communicative inability (as observed by the researcher or clinician) to understand device instructions and participate in the tests
Exclusion criteria
Exclusion criteria: 1. (Severe) visual or hearing impairments (after corrective aids) that would prevent participants from seeing the visual display or hearing the audio cues provided 2. (Severe) visual hallucinations or illusions 3. Physically unable to wear the augmented reality glasses (e.g., presence of a head injury). 4. Unable to use the augmented reality glasses due to health condition (e.g., which would make wearing the glasses uncomfortable) 5. Patient is currently taking part in another study using augmented reality software 6. Patient has used augmented reality software in the last 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mobility, balance, walking ability, and fall risk measured using the Timed Up and Go (TUG) test at 8 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/08/2025: 1. Quality of life measured using the EQ-5D-5L at 8 and 20 weeks post-randomisation 2. Difficulties in daily living measured using the Parkinson's Disease Questionnaire (PDQ-39) at 8 and 20 weeks post-randomisation 3. Balance performance measured using the Mini-BESTest at 8 and 20 weeks post-randomisation 4. Falls measured using the DRESDEN Falls Questionnaire at 8 and 20 weeks post-randomisation 5. Freezing of gait measured using the Freeze of Gait Questionnaire (FOG) at 8 and 20 weeks post-randomisation 6. Fall risk measured using the 10-meter walk test and the sit-to-stand test at 8 and 20 weeks post-randomisation 7. Participant engagement with the intervention measured using concordance data at 8 and 20 weeks post-randomisation 8. Health resource use measured with health resource use information at 8 and 20 weeks post-randomisation 9. Mobility, balance, walking ability, and fall risk measured using the TUG test at 20 weeks post-randomisation Previous secondary outcome measures: 1. Quality of life measured using the EQ-5D-5L at 8 and 20weeks post-randomisation 2. Difficulties in daily living measured using the Parkinson's Disease Questionnaire (PDQ-39) at 8 and 20weeks post-randomisation 3. Function measured using the Lindop Parkinson’s Mobility Assessment Scale at 8 and 20weeks post-randomisation 4. Balance measured using the Berg Balance Scale at 8 and 20weeks post-randomisation 5. Mobility, balance, walking ability, and fall risk measured using the TUG test at 20 weeks post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public Contact- -
Outcome results
None listed