Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 12:28 PM
Study NCT ID:
NCT04719468
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2020-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PD-Ballet: Effectiveness and Implementation in Parkinson's Disease
Sponsor:
King's College Hospital NHS Trust
Organization:
Study Overview
Official Title:
Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Current literature consistently demonstrates beneficial motor effects of dance-based therapies in Parkinson's disease, along with improved quality of life. Little is known about the non-motor gains following such therapy. To date, no RTC has been conducted to investigate the benefits of ballet dancing in Parkinson's disease.
The investigators aim to recruit 160 people with Parkinson's to either: participate in a 12-week ballet-based dancing intervention followed by a 'social Tea and Biscuit' session, or 12-week usual treatment monitoring and 'social Tea and Biscuit' sessions taking place after each intervention session. This study employs a randomised, controlled, single-blind, hybrid type 2 design with a hybrid implementation protocol to investigate both clinical efficacy of the programme and implementation aspects. The project's primary outcome measure is centered around non-motor symptoms of PD. Other measures include motor assessments, wearable sensors and quality of life assessments.
Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.
The investigators aim to recruit 160 people with Parkinson's to either: participate in a 12-week ballet-based dancing intervention followed by a 'social Tea and Biscuit' session, or 12-week usual treatment monitoring and 'social Tea and Biscuit' sessions taking place after each intervention session. This study employs a randomised, controlled, single-blind, hybrid type 2 design with a hybrid implementation protocol to investigate both clinical efficacy of the programme and implementation aspects. The project's primary outcome measure is centered around non-motor symptoms of PD. Other measures include motor assessments, wearable sensors and quality of life assessments.
Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.
Detailed Description:
Parkinson's Disease is a neurodegenerative condition currently affecting over 120,000 people in the UK and this number is set to double by 2065. The current treatment is based around symptomatic pharmacotherapy with levodopa being the gold standard. Currently there is some evidence for non-pharmacological treatments outlined by NICE guidelines, with no recommendations to specific adjuvant non-pharmacotherapies to aid PD symptoms, other than referral for physiotherapy. However, physical exercise has been shown to improve balance, strength, coordination and gait, leading to a significant improvement in quality of life.
While a clear benefit of physical exercise on the motor symptoms is evident, few studies to date focused on the effects of group classes and on non-motor effects. Dance is emerging as a therapeutic option with cognitive, functional and psychosocial benefits, due to it being a multi-dimensional activity offering auditory, visual and sensory stimulation, musical experience, social interaction, memory, motor learning and emotional perception, expression and interaction and as such stimulating multiple pathways. To date, no research has explored acute and chronic effects of exercise based interventions (such as dance therapy with ballet) in comparison to the conventional therapy-based management of Parkinson's.
This is a randomised, controlled, single-blind study involving 160 PwP across all stages of the disease. Participants will be allocated to either standard therapy plus 12 weekly sessions of ballet-based dancing followed by 'Tea and Biscuit' session or standard therapy with 'Tea and Biscuit' session on a 2:1 ratio. Non-motor symptoms, motor symptoms and quality of life will be measured using validated scales, questionnaires and wearable sensor recordings (Parkinson's KinetiGraph, GaitSmart). Furthermore, electrophysiological measures will be performed to determine the effects on cortical activity in a subgroup of participants. Assessments will be performed by a blinded rater at baseline and at the end of the intervention. The project will also explore the possibility of implementation of such therapy into the current pathways.
Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.
While a clear benefit of physical exercise on the motor symptoms is evident, few studies to date focused on the effects of group classes and on non-motor effects. Dance is emerging as a therapeutic option with cognitive, functional and psychosocial benefits, due to it being a multi-dimensional activity offering auditory, visual and sensory stimulation, musical experience, social interaction, memory, motor learning and emotional perception, expression and interaction and as such stimulating multiple pathways. To date, no research has explored acute and chronic effects of exercise based interventions (such as dance therapy with ballet) in comparison to the conventional therapy-based management of Parkinson's.
This is a randomised, controlled, single-blind study involving 160 PwP across all stages of the disease. Participants will be allocated to either standard therapy plus 12 weekly sessions of ballet-based dancing followed by 'Tea and Biscuit' session or standard therapy with 'Tea and Biscuit' session on a 2:1 ratio. Non-motor symptoms, motor symptoms and quality of life will be measured using validated scales, questionnaires and wearable sensor recordings (Parkinson's KinetiGraph, GaitSmart). Furthermore, electrophysiological measures will be performed to determine the effects on cortical activity in a subgroup of participants. Assessments will be performed by a blinded rater at baseline and at the end of the intervention. The project will also explore the possibility of implementation of such therapy into the current pathways.
Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.
Study Oversight
Has Oversight DMC:
False
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?: