Keep On Keep Up for Parkinson's (KOKU4PD)

Keep On Keep Up (KOKU4PD) - Developing an App for People With Parkinson's Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: KOKU4PD

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne & Wear
    • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
      • Northumbria University
      • Contact: Gill Barry, PhD; Phone Number: 01912277635; Email: gill.barry@northumbria.ac.uk
      • Contact: Julia Das; Phone Number: 01912373343; Email: julia.das@northumbria.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KOKU user; SIngle arm study - all participants will use the KOKU app for 4 weeks.	Device: KOKU4PD; Exercise at home using the KOKU app for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trail Making Test (mean Change from baseline)	Timed written test of visual function and scanning	After 4 weeks of using KOKU at home
Freezing of Gait Questionnaire (mean Change from baseline)	Self-report questionnaire	After 4 weeks of using KOKU at home
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Newcastle University; University of Manchester; Northumbria Healthcare NHS Foundation Trust; Reason Digital

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Technology; Co-design; Falls prevention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: H-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be available to members of the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No