Keep On Keep Up for Parkinson's

NCT06332794 | Not Yet Recruiting

• 1 other identifier: H-2201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.
2. 2.To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.

Conditions

Parkinson's Disease

Keywords

Exercise; Falls prevention; Technology; Physical activity; Co-design

Outcome Measures

Primary Outcomes (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.

  After 4 weeks of using KOKU at home

Secondary Outcomes (11)

• Executive clock drawing task (CLOX 1, 2) (mean Change from baseline)

  After 4 weeks of using KOKU at home

• Trail Making Test (mean Change from baseline)

  After 4 weeks of using KOKU at home

• Freezing of Gait Questionnaire (mean Change from baseline)

  After 4 weeks of using KOKU at home

• Falls Efficacy scale (mean Change from baseline)

  After 4 weeks of using KOKU at home

• Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline)

  After 4 weeks of using KOKU at home

Study Arms (1)

KOKU user

EXPERIMENTAL

SIngle arm study - all participants will use the KOKU app for 4 weeks.

Device: KOKU4PD

Interventions

KOKU4PD DEVICE

Exercise at home using the KOKU app for 4 weeks.

KOKU user

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• University of Manchester: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator
• Newcastle University: collaborator
• Reason Digital: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: June 3, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)