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.
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.
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.
- Conditions
- Parkinson Disease
- 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 group | Role | What they receive |
|---|---|---|
| digital dance for PD | Experimental | Not described Receives: Device: Digital dance for PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Fatigue
Fatigue measured by Checklist Individual Strength Questionnaire (CIS). Total score: 20-140
Measured: 12 weeks (pretest - posttest)
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)
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)
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.
- First posted28 Jun 2021
- Study start4 Sep 2020
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karlstad University
- Responsible party
- Principal investigator, Anna Stigsdotter Neely, Umeå University
- Investigators
- Anna S Neely, prof, Principal investigator, Umeå University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04942392
- Acronym / sponsor ID
- 136/2019
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karlstad University
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 28 Jun 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digital dance for PD | Experimental | Device: Digital dance for PD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported diagnosis of Parkinson's Disease
- Participant in Dance for PD at Balettakademien, Stockholm, Sweden
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Digital dance for PDThe 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. | Device | digital dance for PD |
Primary outcome
Feasibility outcome measures
Time frame: Assessed at post-test
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.
14 secondary outcomes
Depression and anxiety
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Summary index
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) - Bodily discomfort
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Communication
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Cognition
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Social support
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Stigma
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Emotional well being
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) Activity of Daily Living
Time frame: 12 weeks (pretest - posttest)
Quality of life (QoL) - Mobility
Time frame: 12 weeks (pretest - posttest)
Fatigue
Time frame: 12 weeks (pretest - posttest)
Subjective cognitive complaints
Time frame: 12 weeks (pretest - posttest)
Mental fatigue
Time frame: 12 weeks (pretest - posttest)
Experience and meaning of digital dance for people with PD
Time frame: Assessed at post-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 35185746Walton 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.
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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.
Anna S Neely, prof principal investigator
Umeå University
1 site in 1 country: see every site and its status.
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.