Clinical trial NCT06332794: Keep On Keep Up for Parkinson's
Official title: Keep On Keep Up (KOKU4PD) - Developing an App for People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Exercise
Falls prevention
Technology
Physical activity
Co-design
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Northumbria Healthcare NHS Foundation Trust
name: Newcastle University
name: Reason Digital
First posted: 2024-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Keep on Keep Up (KOKU) is a digital program available on a tablet that has been designed to engage people in safe and effective falls prevention exercises. KOKU incorporates evidence-based exercise programmes for balance and function and has demonstrated high usability and acceptability in older adults. KOKU is approved by NHS Digital as compliant with regulatory data and safety standards.

Earlier work by the research team has shown that KOKU is effective in improving balance in older adults. However, the effectiveness of KOKU in PD is unknown. The purpose of this study is to explore if app-based exercise is feasible, acceptable and effective in PD, especially in harder-to-reach populations who may not exercise on a regular basis.

Through mixed methods approaches, the proposed study aims to: (i) explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective and (ii) produce a KOKU4PD digital program that is ready for NHS approval and a future effectiveness evaluation.

20 people with PD will be recruited to take part in the study where they will be asked to use the KOKU app independently at home for 4 weeks. A repeated measure design will be employed with assessments performed at the clinical gait lab during two separate sessions lasting between 2-3 hours. Participants will attend the lab for outcomes to be measured at the start and after 4 weeks of exercise with the KOKU app. During the second lab visit, participants will complete a questionnaire about the usability of the KOKU app and take part in an interview to explore their experiences of using it.

Eligibility criteria: 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

Primary outcomes:
measure: Usability of the KOKU app
timeFrame: After 4 weeks of using KOKU at home
Secondary outcomes:
measure: Executive clock drawing task (CLOX 1, 2) (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Trail Making Test (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Freezing of Gait Questionnaire (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Falls Efficacy scale (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Mini-BESTest (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Two minute walk test, single and dual task (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Multidimensional Fatigue Inventory (MFI) (mean Change from baseline)
timeFrame: After 4 weeks of using KOKU at home
measure: Technology Acceptance questionnaire
timeFrame: After 4 weeks of using KOKU at home
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne & Wear
Study officials:
References: