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PD-Ballet: Effectiveness and Implementation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04719468
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Dance with ballet elements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded rater
Primary Purpose: Treatment
Official Title: Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Other: Dance with ballet elements
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.

No Intervention: Usual Treatment
usual treatment with the addition of joining 'Tea and Biscuit' sessions remotely



Primary Outcome Measures :
  1. 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.

  2. Acceptability of Intervention Measure [ Time Frame: post intervention (week 12) ]
    Implementation Effectiveness Primary Outcome Measure - a 4 item, 5-point likert scale


Secondary Outcome Measures :
  1. 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 ]
    Clinical Effectiveness. A higher score indicates worse motor condition

  2. 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 ]
    Clinical Effectiveness. Time taken to walk 10 meters is calculated and compared at specific timepoints.

  3. 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 ]
    Clinical Effectiveness. A higher score indicates worse levels of pain

  4. 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 ]
    Clinical Effectiveness. Time taken to carry out the test measured. A change between timepoints will be measured.

  5. 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 Effectiveness. Maximum score 30. Lower scores indicate cognitive impairment.

  6. 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 ]
    provides a clinical judgment on Parkinson's disease (PD) severity based on motor symptoms and complications, cognitive status, and disability

  7. 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 ]
    Clinical Effectiveness. Higher score indicates worse sleep quality

  8. 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 ]
    Clinical Effectiveness. A higher score indicates worse quality of life.

  9. 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 ]
    Clinical Effectiveness. Higher score indicates worse anxiety and depression.

  10. 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 ]
    Clinical Effectiveness. A higher score indicates higher level of independence in performing activities of daily living.

  11. 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 ]
    Clinical Effectiveness. A lower score indicates better quality of life

  12. 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 ]
    Clinical Effectiveness. A higher score indicates more fatigue.

  13. 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 ]
    Clinical Effectiveness. A higher score indicates more activity

  14. 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 ]
    Clinical Effectiveness. Higher score indicates more apathy.

  15. 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 ]
    Clinical Effectiveness. Higher score indicates worse wearing-off.

  16. 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 ]
    Clinical Effectiveness. A higher score indicates more carer burden.

  17. 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 ]
    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.

  18. 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 ]
    Clinical Effectiveness, objective artigraphy based wearable sensor worn at home for 6 days at each time point.

  19. 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 ]
    Implementation Effectiveness - a 4-item, 5-point likert scale

  20. 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 ]
    Implementation Effectiveness - a 4-item, 5-point likert scale

  21. 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 Effectiveness - a 19 item implementation science survey (Finch et al., 2015)

  22. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Effectiveness investigation eligibility criteria (PwPs only)

  1. 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
  2. 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

    g) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719468


Contacts
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Contact: Aleksandra Podlewska, MSc 02032997189 aleksandra.podlewska@nhs.net

Locations
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United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Contact: Aleksandra Podlewska, MSc    02032997189    aleksandra.podlewska@nhs.net   
Contact: Lucia Batzu, MD    02032997189    l.batzu@nhs.net   
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
Investigators
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Principal Investigator: K Ray Chaudhuri, Professor King's College London
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04719468    
Other Study ID Numbers: 275588
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College Hospital NHS Trust:
dance
ballet
complementary therapy
exercise
multimodal
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases