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Parkinson's DiseaseKOKU4PDNCT06332794

Keep On Keep Up for Parkinson's

A study testing KOKU4PD in people with Parkinson's Disease, run by Northumbria University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
KOKU4PD
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
3 Jun 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Northumbria University

    Newcastle upon Tyne, Tyne & Wear, NE1 8ST

    Gill Barry, PhD, 01912277635, gill.barry@northumbria.ac.uk

    Julia Das, 01912373343, julia.das@northumbria.ac.uk

Other trials in United Kingdom

About this study

Official title: 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:

Read more
  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.

Read the 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.

Being tested
KOKU4PD
Keywords
Exercise, Falls prevention, Technology, Physical activity, Co-design
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KOKU4PDDevice

    Exercise at home using the KOKU app for 4 weeks.

Study groups in NCT06332794
Study groupRoleWhat they receive
KOKU userExperimentalSIngle arm study - all participants will use the KOKU app for 4 weeks.
Receives: Device: KOKU4PD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After 4 weeks of using KOKU at home

Secondary outcomes (11)

  1. 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.

    Measured: After 4 weeks of using KOKU at home

  2. Trail Making Test (mean Change from baseline)

    Timed written test of visual function and scanning

    Measured: After 4 weeks of using KOKU at home

  3. Freezing of Gait Questionnaire (mean Change from baseline)

    Self-report questionnaire

    Measured: After 4 weeks of using KOKU at home

  4. Falls Efficacy scale (mean Change from baseline)

    Self-report questionnaire (minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)

    Measured: After 4 weeks of using KOKU at home

  5. 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).

    Measured: After 4 weeks of using KOKU at home

  6. 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.

    Measured: After 4 weeks of using KOKU at home

  7. 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

    Measured: After 4 weeks of using KOKU at home

  8. 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.

    Measured: After 4 weeks of using KOKU at home

  9. 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.

    Measured: After 4 weeks of using KOKU at home

  10. 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.

    Measured: After 4 weeks of using KOKU at home

  11. 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).

    Measured: After 4 weeks of using KOKU at home

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start3 Jun 2024 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06332794
Sponsor's protocol ID
H-2201
Acronym
KOKU4PD
Status last verified
Apr 2024
First submitted
20 Mar 2024
Last updated
24 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will only be available to members of the study team.

Questions about this trial

What is this clinical trial studying?

A study testing KOKU4PD in people with Parkinson's Disease, run by Northumbria University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of the KOKU app (time frame: After 4 weeks of using KOKU at home). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06332794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.

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Keep On Keep Up for Parkinson's (NCT06332794) | AzTrials