Parkinson DiseaseNCT04719468
PD-Ballet: Effectiveness and Implementation in Parkinson's Disease
A study testing Dance with ballet elements in people with Parkinson Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dance with ballet elements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 1 Sep 2023
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Effectiveness investigation eligibility criteria (PwPs only)
- Inclusion:
- Age of 18 and upwards
- diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD Brain Bank criteria
- Hoehn Yarhr stages I-V
- Exclusion:
- diagnosis or suspicion of other causes for parkinsonism
- advanced-stage therapy consideration (deep brain stimulation, continuous levodopa duodenal infusion, and continuous subcutaneous apomorphine infusion)
- any condition interfering with the ability to give the informed consent
- Indication of dementia through a score of ≤21 on MoCA
- enrolment in a simultaneous investigational trial
- inability to travel to the weekly sessions
Implementation science investigation eligibility criteria f) Inclusion:
- People with Parkinson's - patients with a formal diagnosis of PD who have participated in the PD-Ballet intervention.
- Family members of PwP - relatives/carers/nominated person of the patients with a formal diagnosis of PD who have participated in the PD-Ballet intervention
- Clinicians (Referrers) - neurologists/geriatricians/neuropsychiatrists/SALT/OT, as well as PD specialist nurses, physicians and research staff experienced in PD
- Dance leaders (Deliverers) - English National Ballet dancers involved in the PD-Ballet project
- Support staff (Supporters)- other parties involved with the PD-Ballet project
- Exclusion:
- People with Parkinson's - parkinsonism other than PD, lack of involvement in the PD-Ballet project
- Clinicians - Neurologists/geriatricians/neuropsychiatrists/SALT/OT, as well as PD specialist nurses, physicians and research staff experienced in PD
- Dance leaders - English National Ballet dancers not involved in the PD-Ballet project
- Support staff - other parties not involved with the PD-Ballet project
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Aleksandra Podlewska, MSc, 02032997189, aleksandra.podlewska@nhs.net
Lucia Batzu, MD, 02032997189, l.batzu@nhs.net
About this study
Official title: Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Dance with ballet elements
- Keywords
- dance, ballet, complementary therapy, exercise, multimodal
- 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.
Dance with ballet elementsOther
Ballet-based dance sessions will be delivered by trained artists within the English National Ballet group in a professional dance space/ delivered remotely, COVID-19 permitting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Dance with ballet elements |
| Usual Treatment | No intervention | usual treatment with the addition of joining 'Tea and Biscuit' sessions remotely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score of the Movement Disorders Society Sponsored Non-Motor Rating Scale
Clinical Effectiveness Primary Outcome Measure, higher score indicate worse non-motor symptomatology, the maximum score is 1008.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Acceptability of Intervention Measure
Implementation Effectiveness Primary Outcome Measure - a 4 item, 5-point likert scale
Measured: post intervention (week 12)
Secondary outcomes (22)
Change in total score of the Unified Parkinson's Disease Rating Scale
Clinical Effectiveness. A higher score indicates worse motor condition
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of 10-meter walk test
Clinical Effectiveness. Time taken to walk 10 meters is calculated and compared at specific timepoints.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of King's Parkinson's Pain Scale
Clinical Effectiveness. A higher score indicates worse levels of pain
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Timed Up and Go test
Clinical Effectiveness. Time taken to carry out the test measured. A change between timepoints will be measured.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Montreal Cognitive Assessment
Clinical Effectiveness. Maximum score 30. Lower scores indicate cognitive impairment.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Clinical Impression of Severity Index for Parkinson's disease
provides a clinical judgment on Parkinson's disease (PD) severity based on motor symptoms and complications, cognitive status, and disability
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Parkinson's Disease Sleep Scale 2
Clinical Effectiveness. Higher score indicates worse sleep quality
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Parkinson's Disease Questionnaire-8
Clinical Effectiveness. A higher score indicates worse quality of life.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score and sub-scores of Hospital Anxiety and Depression Scale
Clinical Effectiveness. Higher score indicates worse anxiety and depression.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Schwab and England Scale
Clinical Effectiveness. A higher score indicates higher level of independence in performing activities of daily living.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of EQ-5D-5L questionnaire
Clinical Effectiveness. A lower score indicates better quality of life
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Parkinson's Fatigue Scale-16
Clinical Effectiveness. A higher score indicates more fatigue.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Physical Activity Scale for the Elderly
Clinical Effectiveness. A higher score indicates more activity
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Starkstein Apathy Scale
Clinical Effectiveness. Higher score indicates more apathy.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Wearing Off Questionnaire-9
Clinical Effectiveness. Higher score indicates worse wearing-off.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Zaritt Burden Interview
Clinical Effectiveness. A higher score indicates more carer burden.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Electrodiagnostic Measures - Transcranial Magnetic Stimulation paired with Electroencephalography and electromyography.
Clinical Effectiveness - exploratory measure. EMG data are analysed via Spike2 software (Cambridge Electronic Design). Peak-to-peak MEP amplitudes are measured for each trial and averaged per condition. SICI is calculated as the ratio of mean conditioned MEP to mean unconditioned MEP. TMS-evoked EEG potentials will be calculated by averaging artifact-free EEG trials for each experimental condition (i.e., before and after intervention). To smooth the signal a low-pass filter of 45 Hz will be applied to TEPs. The aim is to evaluate drug-induced changes for the 5 typical TEPs components (P = Positive, N = Negative) in accordance with the literature: N15-P25, N45, P70, N100, and P180.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in the scores of Parkinson's KinetiGraph parameters (bradykinesia, dyskinesia, tremor, immobility)
Clinical Effectiveness, objective artigraphy based wearable sensor worn at home for 6 days at each time point.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Feasibility of Intervention Measure (FIM)
Implementation Effectiveness - a 4-item, 5-point likert scale
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Intervention Appropriateness Measure (IAM)
Implementation Effectiveness - a 4-item, 5-point likert scale
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Sustainability scale (NOMAD)
Implementation Effectiveness - a 19 item implementation science survey (Finch et al., 2015)
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Implementation costs
Health Economics - questionnaire regarding the potentially incurred costs related to clinical care for a person with Parkinson. The investigators will measure the potential change in direct and indirect costs incurred from clinical care.
Measured: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- K Ray Chaudhuri, Professor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719468
- Sponsor's protocol ID
- 275588
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Podlewska AM, Batzu L, Soukup T, Sevdalis N, Bakolis I, Derbyshire-Fox F, Hartley A, Healey A, Woods A, Crane N, Pariante C, Ray Chaudhuri K. The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease. BMC Complement Med Ther. 2024 Jan 17;24(1):41. doi: 10.1186/s12906-023-04296-y.
PubMed 38233784Soukup T, Davis RE, Baldellou Lopez M, Healey A, Estevao C, Fancourt D, Dazzan P, Pariante C, Dye H, Osborn T, Bind R, Sawyer K, Rebecchini L, Hazelgrove K, Burton A, Manoharan M, Perkins R, Podlewska A, Chaudhuri R, Derbyshire-Fox F, Hartley A, Woods A, Crane N, Bakolis I, Sevdalis N. Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease. BMJ Open. 2022 Feb 1;12(2):e055691. doi: 10.1136/bmjopen-2021-055691.
PubMed 35105591
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial
- ClinicalTrials.gov ID
- NCT04719468
- Acronym / sponsor ID
- 275588
- Conditions
- Parkinson Disease
- Keywords
- dance, ballet, complementary therapy, exercise, multimodal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dance with ballet elements |
| Usual Treatment | No intervention | –usual treatment with the addition of joining 'Tea and Biscuit' sessions remotely |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance with ballet elementsBallet-based dance sessions will be delivered by trained artists within the English National Ballet group in a professional dance space/ delivered remotely, COVID-19 permitting. | Other | Intervention |
Primary outcome
Change in total score of the Movement Disorders Society Sponsored Non-Motor Rating Scale
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Clinical Effectiveness Primary Outcome Measure, higher score indicate worse non-motor symptomatology, the maximum score is 1008.
Acceptability of Intervention Measure
Time frame: post intervention (week 12)
Implementation Effectiveness Primary Outcome Measure - a 4 item, 5-point likert scale
22 secondary outcomes
Change in total score of the Unified Parkinson's Disease Rating Scale
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of 10-meter walk test
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of King's Parkinson's Pain Scale
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Timed Up and Go test
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Montreal Cognitive Assessment
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Clinical Impression of Severity Index for Parkinson's disease
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Parkinson's Disease Sleep Scale 2
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Parkinson's Disease Questionnaire-8
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score and sub-scores of Hospital Anxiety and Depression Scale
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Schwab and England Scale
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of EQ-5D-5L questionnaire
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Parkinson's Fatigue Scale-16
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Physical Activity Scale for the Elderly
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Starkstein Apathy Scale
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Wearing Off Questionnaire-9
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in total score of Zaritt Burden Interview
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Electrodiagnostic Measures - Transcranial Magnetic Stimulation paired with Electroencephalography and electromyography.
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Change in the scores of Parkinson's KinetiGraph parameters (bradykinesia, dyskinesia, tremor, immobility)
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Feasibility of Intervention Measure (FIM)
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Intervention Appropriateness Measure (IAM)
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Sustainability scale (NOMAD)
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Implementation costs
Time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 38233784Podlewska AM, Batzu L, Soukup T, Sevdalis N, Bakolis I, Derbyshire-Fox F, Hartley A, Healey A, Woods A, Crane N, Pariante C, Ray Chaudhuri K. The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease. BMC Complement Med Ther. 2024 Jan 17;24(1):41. doi: 10.1186/s12906-023-04296-y.
- Derived from this study: PubMed 35105591Soukup T, Davis RE, Baldellou Lopez M, Healey A, Estevao C, Fancourt D, Dazzan P, Pariante C, Dye H, Osborn T, Bind R, Sawyer K, Rebecchini L, Hazelgrove K, Burton A, Manoharan M, Perkins R, Podlewska A, Chaudhuri R, Derbyshire-Fox F, Hartley A, Woods A, Crane N, Bakolis I, Sevdalis N. Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease. BMJ Open. 2022 Feb 1;12(2):e055691. doi: 10.1136/bmjopen-2021-055691.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K Ray Chaudhuri, Professor principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance with ballet elements in people with Parkinson Disease, run by King's College Hospital NHS Trust 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?
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 20 Apr 2021. 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?
Contact Aleksandra Podlewska, MSc (02032997189, aleksandra.podlewska@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total score of the Movement Disorders Society Sponsored Non-Motor Rating Scale (time frame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability). The study lists 2 primary outcomes in all. 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 NCT04719468, which also lists 2 linked publications.
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 20 Apr 2021.