Authors
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Stuart, Sam, Das, Julia -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2021
INTERVENTION: This is a cross‐over trial which means after participants have been screened for eligibility, they will be assessed, randomly split into two equal size groups (group A and group B) using a computer‐generated random number sequence, and then have two 4‐week training periods involving two different visual training interventions. Following the informed written consent procedure, participants (n=40) will be required to answer some demographic questions, such as education level, falls history, and activity level. They then will complete clinical assessments (such as the Unified Parkinson's Disease Rating scale) and a battery of neuropsychology and opthalmological assessments, which involve answering some questions and completing some pen and paper or computerised tasks. All assessments will take place at the Clinical Gait Lab at the Coach Lane Campus, Northumbria University. Participants will undergo a total of 3 assessments: at baseline, after the first 4‐week intervention, and after the second 4‐week intervention. There will be a two‐week break between training periods so that the effects of the first intervention have worn off before participants start the next intervention. Participants will receive the following two interventions (the order depending on whether they are in Group A or Group B): 1. Technological visual training (TVT), an intervention involving visual training with strobe glasses and a mobile application. 2. Active control intervention involving tasks, drills, and modified games that are currently used in clinical practice. All training interventions will take place in participants' own homes and with a qualified physiotherapist from the research team pres CONDITION: Parkinson's Disease ; Nervous System Diseases ; Parkinson disease PRIMARY OUTCOME: Visual attention measured using the Visual Trail Making Test (TMT) Parts A and B at baseline, 4, and 12 weeks INCLUSION CRITERIA: 1. Clinical diagnosis of Parkinson’s by a movement disorder specialist according to UK brain bank criteria (Hoehn and Yahr stage I‐III) 2. Aged >50 years 3. Able to walk and stand without support or assistance from another person 4. Have adequate hearing/vision capabilities to allow participation in all aspects of the study (if participant wears prescription glasses, they must be comfortable to remove these for short periods of up to 5 min at a time in order to take part in activities whilst wearing strobe glasses) 5. Stable medication for the previous 1 month and anticipated over a period of 6 months. SECONDARY OUTCOME: ; 1. Mood measured using the Geriatric depression scale (GDS‐15) at baseline; 2. General cognition measured using the following:; 2.1. Montreal cognitive assessment (MoCA) at baseline; 2.2. The Penn Parkinson's Daily Activities Questionnaire‐15 (PDAQ‐15) at baseline, 4, and 12 weeks; 2.3. Attention Computer Battery at baseline, 4, and 12 weeks; 3. Visuospatial ability measured using Benton’s Judgement of Line Orientation Test and the Clock copying task (Royall’s CLOX 1 + 2) at baseline, 4, and 12 weeks; 4. Visual acuity measured using LogMAR at baseline, 4, and 12 weeks; 5. Contrast sensitivity measured using the Mars Letter Contrast Sensitivity Test at baseline, 4, and 12 weeks; 6. Visual and sensorimotor skills measured using Senaptec Sensory Station at baseline, 4, and 12 weeks; 7. Parkinson's disease status measured using the Hoehn & Yahr (H & Y) scale at baseline; 8. Motor symptoms measured using the Unified Parkinson's Disease Rating Scale (UPDRS‐III) at baseline, 4, and 12 weeks; 9. Freezing of Gait measured using the new Freezing of Gait questionnaire (FOGQ) at baseline, 4, and 12 weeks; 10. Falls measured using the Falls efficacy scale‐ International (FES‐I) at baseline, 4, and 12 weeks; 11. Quality of Life measured using Parkinson’s Disease Questionnaire‐ 39 (PDQ‐39) at baseline, 4, and 12 weeks; 12. Balance measured using Mini Best Test at baseline, 4, and 12 weeks; 13. Gait measured using Timed up and Go and the 10 m walk test at baseline, 4, and 12 weeks; 14. Fatigue measured using the Fatigue Severity Scale at baseline, 4, and 12 weeks; 15. Participation (effort/motivation) measured using Pittsburgh Rehabilitation Participation Scale at baseline, 4, and 12 weeks; 16. Usability of visual training technology measured using Systems Usability Scale at either 4 weeks or 12 weeks; 17. Participant experience measured using Semi‐structured Interviews at 12 weeks;
Epistemonikos ID: 6e468e2d5fd28ee7420ef4882a36314d4e5feca0
First added on: Oct 16, 2021