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Parkinson DiseaseNCT04942392

Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic

A study testing Digital dance for PD in people with Parkinson Disease, run by Umeå University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dance as a treatment to support physical, cognitive and emotional functioning, has gained increased acceptance as a healthcare intervention for people with Parkinson's Disease (PD). The impact of the COVID-19 pandemic has been far reaching with devastating effects for at-risk populations. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson Disease
What is being tested?
Digital dance for PD
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSweden
Study dates
4 Sep 2020to 3 Dec 2020
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Self-reported diagnosis of Parkinson's Disease
  • Participant in Dance for PD at Balettakademien, Stockholm, Sweden

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Balettakademien

    Stockholm

Other trials in Sweden

About this study

Official title: Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic: A Feasibility Study

Dance as a treatment to support physical, cognitive and emotional functioning, has gained increased acceptance as a healthcare intervention for people with Parkinson's Disease (PD). The impact of the COVID-19 pandemic has been far reaching with devastating effects for at-risk populations. To find alternative and safe treatment delivery options during the pandemic has been of outmost importance.

This mixed-methods, feasibility study on digital for people with Parkinson's Disease aimed to investigate: (1) the feasibility and safety of a digital home-based dance intervention for people with PD; (2) change in self-reported quality of life, cognitive complaints, psychological health and fatigue; and (3) the experience of digital dance for people with PD.

Twenty-three participants partook in 10 weekly digital dance classes at home via zoom. Feasibility outcomes measures were administered at post-test. Pre-post changes in self-reported quality of life, cognitive complaints, psychological health and fatigue were measured, as well as the experience of digital dance via focus groups.

Being tested
Digital dance for PD
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital dance for PDDevice

    The digital dance class was held via Zoom. The class was scheduled once a week for 60 min and consisted of 10 sessions. A professional, certified Dance for PD and experienced dance instructor was teaching the dance class. The dance classes followed the Dance for PD protocol yet was adjusted to fit the digital zoom format.

Study groups in NCT04942392
Study groupRoleWhat they receive
digital dance for PDExperimentalNot described
Receives: Device: Digital dance for PD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility outcome measures

    The following feasibility outcome measures were assessed: (a) Technical and safety issues, (b) Compliance and motivation, (c) Self-assessed improvement in physical function, wellbeing and cognitive function and (d) The importance of dance as an artistic and creative activity.

    Each feasibility outcome measure was assessed via a 5-point Likert scale ranging from (1=very unsatisfactory, 5=very satisfactory), (1=not motivated, 5=very motivated), (1=noticeable worsening, 5=noticeable improvement) or (1=not meaningful, 5=very meaningful). Furthermore, each feasibility outcome measure had an open-ended question connected to it in order to capture any details related that feasibility domain. Two open-ended questions regarding positive and negative aspects of digital dancing were also included.

    For each feasibility outcome measure, a criterion of success was developed in order to judge the the success rate of these feasibility outcome measures.

    Measured: Assessed at post-test

Secondary outcomes (14)
  1. Depression and anxiety

    Severity of depression and anxiety symptoms measured by Hospital Anxiety Depression scale Anxiety score: 0-21 higher score indicate more anxiety Depression score: 0-21 higher score indicate more depression

    Measured: 12 weeks (pretest - posttest)

  2. Quality of life (QoL) Summary index

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39), Summary index: 0-100 higher scores indicate more problems.

    Furthermore, scores on the following subscales were assessed:

    • Mobility score: 0-100 higher scores indicate more problems
    • Activity of Daily Living score: 0-100 higher scores indicate more problems
    • Emotional well being score: 0-100 higher scores indicate more problems
    • Stigma score: 0-100 higher scores indicate more problems
    • Social support score: 0-100 higher scores indicate more problems
    • Cognition score: 0-100 higher scores indicate more problems
    • Communication score: 0-100 higher scores indicate more problems
    • Bodily discomfort score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  3. Quality of life (QoL) - Bodily discomfort

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale: Bodily discomfort score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  4. Quality of life (QoL) Communication

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale: Communication score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  5. Quality of life (QoL) Cognition

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale:Cognition score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  6. Quality of life (QoL) Social support

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale: Social support score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  7. Quality of life (QoL) Stigma

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale: Stigma score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  8. Quality of life (QoL) Emotional well being

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale: Emotional well being score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  9. Quality of life (QoL) Activity of Daily Living

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale: Activity of Daily Living score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  10. Quality of life (QoL) - Mobility

    Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39).

    Subscale Mobility score: 0-100 higher scores indicate more problems

    Measured: 12 weeks (pretest - posttest)

  11. Fatigue

    Fatigue measured by Checklist Individual Strength Questionnaire (CIS). Total score: 20-140

    Measured: 12 weeks (pretest - posttest)

  12. Subjective cognitive complaints

    Improvement on subjective memory complaints measured by Prospective Retrospective Memory Questionnaire (PRMQ). Total score: 16-80 higher scores indicate more cognitive complaints prospective score: 0-100 higher scores indicate more cognitive complaints retrospective score: 0-100 higher scores indicate more cognitive complaints short term score: 0-100 higher scores indicate more cognitive complaints long term score: 0-100 higher scores indicate more cognitive complaints self cued score: 0-100 higher scores indicate more cognitive complaints environmentally cued: 0-100 higher scores indicate more cognitive complaints

    Measured: 12 weeks (pretest - posttest)

  13. Mental fatigue

    Two questions from the Mental Fatigue Scale were used to measure mental fatigue (item 3) and recovery (item 4). Answers were given on a 7-point Likert scale.

    Measured: 12 weeks (pretest - posttest)

  14. Experience and meaning of digital dance for people with PD

    Two focus group interviews were conducted to examine the broader experience of digital dance for people with PD.

    Measured: Assessed at post-test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start4 Sep 2020
  3. Primary completion3 Dec 2020
  4. Study completion3 Dec 2020

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942392
Sponsor's protocol ID
136/2019
Status last verified
Jun 2021
First submitted
23 Jun 2021
Last updated
28 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Walton L, Domellof ME, Astrom AN, Elowson A, Neely AS. Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic: A Feasibility Study. Front Neurol. 2022 Feb 3;12:743432. doi: 10.3389/fneur.2021.743432. eCollection 2021.

    PubMed 35185746

Questions about this trial

What is this clinical trial studying?

A study testing Digital dance for PD in people with Parkinson Disease, run by Umeå University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Jun 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 Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility outcome measures (time frame: Assessed at post-test). 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 NCT04942392, which also lists 1 linked publication.

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 28 Jun 2021.

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