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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Digital dance for PD
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Balettakademien

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

digital dance for PD

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2021
Last Updated
June 24, 2021
Sponsor
Umeå University
Collaborators
Karlstad University
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1. Study Identification

Unique Protocol Identification Number
NCT04942392
Brief Title
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
Official Title
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
December 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Karlstad University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
digital dance for PD
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Digital dance for PD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility outcome measures
Description
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.
Time Frame
Assessed at post-test
Secondary Outcome Measure Information:
Title
Depression and anxiety
Description
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
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Summary index
Description
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
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) - Bodily discomfort
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale: Bodily discomfort score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Communication
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale: Communication score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Cognition
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale:Cognition score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Social support
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale: Social support score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Stigma
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale: Stigma score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Emotional well being
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale: Emotional well being score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) Activity of Daily Living
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale: Activity of Daily Living score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Quality of life (QoL) - Mobility
Description
Quality of life measured by Parkinson's Disease Questionnaire-39 (PDQ39). Subscale Mobility score: 0-100 higher scores indicate more problems
Time Frame
12 weeks (pretest - posttest)
Title
Fatigue
Description
Fatigue measured by Checklist Individual Strength Questionnaire (CIS). Total score: 20-140
Time Frame
12 weeks (pretest - posttest)
Title
Subjective cognitive complaints
Description
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
Time Frame
12 weeks (pretest - posttest)
Title
Mental fatigue
Description
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.
Time Frame
12 weeks (pretest - posttest)
Title
Experience and meaning of digital dance for people with PD
Description
Two focus group interviews were conducted to examine the broader experience of digital dance for people with PD.
Time Frame
Assessed at post-test
Other Pre-specified Outcome Measures:
Title
Age
Description
Demographic characteristic: age at baseline
Time Frame
Assessed at pre-test
Title
Sex
Description
Demographic characteristic: sex
Time Frame
Assessed at pre-test
Title
Educational level
Description
Demographic characteristic: educational level
Time Frame
Assessed at pre-test
Title
Previous experience of dance for Parkinson's Disease
Description
Demographic characteristic: previous experience of dance for PD
Time Frame
Assessed at pre-test
Title
Self-evaluated health
Description
Demographic characteristic: self-evaluated health
Time Frame
Assessed a pre-test
Title
Disease duration
Description
Demographic characteristic: self-reported year of PD diagnosis
Time Frame
Assessed at pre-test
Title
Current participation in physical exercise
Description
Demographic characteristic: current participation in physical exercise
Time Frame
Assessed at pre-test

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-reported diagnosis of Parkinson's Disease Participant in Dance for PD at Balettakademien, Stockholm, Sweden Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna S Neely, prof
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balettakademien
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35185746
Citation
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.
Results Reference
derived

Learn more about this trial

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

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