Parkinson's Disease Clinical Trial
— KOKU4PDOfficial title:
Keep On Keep Up (KOKU4PD) - Developing an App for People With Parkinson's Disease
Verified date | April 2024 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD). The main aims of the study are to: 1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective. 2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation. Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria (H&Y stage I-III) - Able to walk and stand without support or assistance from another person - >40 years - Stable medication for the previous 1 month and anticipated over a period of 6 months. - Adequate vision and hearing - to watch and use an iPad or Tablet.Aim: To define the study population/sample Exclusion Criteria: - Dementia (<21 on Montreal Cognitive Assessment (MoCA) or as diagnosed according to the Movement Disorder Society guidelines - Orthopaedic or cardiothoracic ailments that preclude safe walking - Severe auditory or visual impairment, - Diagnosis of clinical depression |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle upon Tyne | Tyne & Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University | Newcastle University, Northumbria Healthcare NHS Foundation Trust, Reason Digital, University of Manchester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usability of the KOKU app | Participants will be asked to complete questionnaires about the usability of the KOKU app and participate in an interview based on their responses to the questionnaires. | After 4 weeks of using KOKU at home | |
Secondary | Executive clock drawing task (CLOX 1, 2) (mean Change from baseline) | A clock drawing task (CLOX) designed to elicit executive impairment and discriminate it from non-executive constructional failure. | After 4 weeks of using KOKU at home | |
Secondary | Trail Making Test (mean Change from baseline) | Timed written test of visual function and scanning | After 4 weeks of using KOKU at home | |
Secondary | Freezing of Gait Questionnaire (mean Change from baseline) | Self-report questionnaire | After 4 weeks of using KOKU at home | |
Secondary | Falls Efficacy scale (mean Change from baseline) | Self-report questionnaire (minimum 16 (no concern about falling) to maximum 64 (severe concern about falling) | After 4 weeks of using KOKU at home | |
Secondary | Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline) | The 39 item questionnaire offers a patient reported measure of health status and quality of life. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100 = more health problems). | After 4 weeks of using KOKU at home | |
Secondary | Mini-BESTest (mean Change from baseline) | The Mini-BESTest is a clinical balance test that has shown a high sensitivity in detecting balance impairments in elderly people with Parkinson's disease. The Mini- BESTest consists of 14 items, with a maximum (best) score of 28 points. | After 4 weeks of using KOKU at home | |
Secondary | Two minute walk test, single and dual task (mean Change from baseline) | Participant walks continually for 2 minutes; for dual task, participant is asked to recall numbers as they are walking | After 4 weeks of using KOKU at home | |
Secondary | EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline) | Self-report quality fo life questionnaire - EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. | After 4 weeks of using KOKU at home | |
Secondary | Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline) | The Activities-specific Balance confidence (ABS) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. There are 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%, how confident they are in performing each activity. The average score obtained is an indication on balance confidence.
A score of > 80% indicates high level of functioning. A score of 50%-80% indicates moderate level of functioning. A score of < 50% indicates low levels of functioning. Additionally, a score of < 67% suggests substantial risk of falling. |
After 4 weeks of using KOKU at home | |
Secondary | Multidimensional Fatigue Inventory (MFI) (mean Change from baseline) | The MFI is a 20-item inventory scored on a 5-point Likert scale and measures five dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI dimension scores range from 4 to 20 (most severe) and have been credited with reliably measuring fatigue severity in each dimension. | After 4 weeks of using KOKU at home | |
Secondary | Technology Acceptance questionnaire | Self-report questionnaire, based on the Technology Acceptance Model. There are 15 items which participants have to rate on a scale of 1 (= strongly disagree) to 7 (strongly agree). | After 4 weeks of using KOKU at home |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
Completed |
NCT02927691 -
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
|
Phase 2 | |
Completed |
NCT02874274 -
Vaccination Uptake (VAX) in PD
|
N/A |