Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2025-12-16 @ 7:59 PM
Study NCT ID:
NCT06332794
Status:
None
Last Update Posted:
2024-04-24 00:00:00
First Post:
2024-03-20 00:00:00
Brief Title:
Keep On Keep Up for Parkinson's
Sponsor:
Northumbria University
Organization:
Northumbria University
Study Overview
Official Title:
Keep On Keep Up (KOKU4PD) - Developing an App for People With Parkinson's Disease
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOKU4PD
Brief Summary:
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.
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.
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None