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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04942392
Other study ID # 136/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2020
Est. completion date December 3, 2020

Study information

Verified date June 2021
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 3, 2020
Est. primary completion date December 3, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Self-reported diagnosis of Parkinson's Disease - Participant in Dance for PD at Balettakademien, Stockholm, Sweden Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Digital dance for PD
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.

Locations

Country Name City State
Sweden Balettakademien Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Umeå University Karlstad University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Age Demographic characteristic: age at baseline Assessed at pre-test
Other Sex Demographic characteristic: sex Assessed at pre-test
Other Educational level Demographic characteristic: educational level Assessed at pre-test
Other Previous experience of dance for Parkinson's Disease Demographic characteristic: previous experience of dance for PD Assessed at pre-test
Other Self-evaluated health Demographic characteristic: self-evaluated health Assessed a pre-test
Other Disease duration Demographic characteristic: self-reported year of PD diagnosis Assessed at pre-test
Other Current participation in physical exercise Demographic characteristic: current participation in physical exercise Assessed at pre-test
Primary 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.
Assessed at post-test
Secondary 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 12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary 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
12 weeks (pretest - posttest)
Secondary Fatigue Fatigue measured by Checklist Individual Strength Questionnaire (CIS). Total score: 20-140 12 weeks (pretest - posttest)
Secondary 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 12 weeks (pretest - posttest)
Secondary 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. 12 weeks (pretest - posttest)
Secondary 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. Assessed at post-test
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