- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03908801
Evaluation of Specialized Water Dance Intervention (SWAN)
Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.
Individuals with profound intellectual and multiple disabilities (PIMD) have extensive health problems and need for personal assistance throughout the day. Few physical- and health promoting activities are available for them and among the activities, few have been scientifically evaluated. Specialized water dance intervention (SWAN) is a new method developed to relieve discomfort and promote physical wellbeing among people with PIMD. The aim of the study is to evaluate the effects of SWAN on stress, spasticity, pain, alertness, wellbeing and social interaction among individuals with PIMD.
Individuals with profound intellectual and multiple disabilities (PIMD) have extensive health problems and need for personal assistance throughout the day. Few physical and health promoting activities are available for them. Among the activities, few have been scientifically evaluated. Specialized water dance intervention (SWAN) is a new method developed to relieve discomfort and promote physical wellbeing among people with PIMD. The aim of the study is to evaluate the effects of SWAN on stress, spasticity, pain, alertness, wellbeing and social interaction among individuals with PIMD.
Prospective randomized controlled intervention study in which the effects of SWAN are tested in a two-group cross-over design with pre-, under- and post-measurements. The study is conducted as a multicenter study with four participating county councils/regions I Sweden (Varmland County Council, Region Orebro County, Region Ostergotland and Region Gavleborg).
The SWAN intervention is given once a week for 3 months (12 occasions). Each SWAN session is 45 minutes and is led by two SWAN leaders.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Örebro, Sweden, 70182
- University Health Care Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have a profound intellectual and multiple disabilities corresponding to level IV-V in the Gross Motor Function Classification System.
- aged 16-65 years
- be accustomed to water and not find discomfort of activities in water.
Exclusion Criteria:
- severe hearing impairment/deafness
- have wounds/infections that are infectious in the pool
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
No intervention
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|
EXPERIMENTAL: Intervention
Specialized water dance intervention
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Group activity in a warm pool (32-34 °C) led by two SWAN leaders.
During each session, nine songs are played and the participants, assisted by a support person, perform dance movements rhythmically to the mood of the music.
The songs are chosen to stimulate different movement patterns and to emphasize different emotions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress
Time Frame: 14 weeks
|
Cortisol in saliva
|
14 weeks
|
Spasticity
Time Frame: 14 weeks
|
The Modified Ashworth Scale is used to assess muscle tone.
The flexor muscles of the elbows and the extensor muscles of the knees on the participants left and right side are tested.
The muscle tone is scored on a 6-point scale from 0 (No increase in muscle tone) to 5 (Affected part(s) is(are) rigid in flexion or extension).
The higher the score, the more resistance to passive movement.
|
14 weeks
|
Wellbeing: Observed (questionnaire)
Time Frame: 12 weeks
|
The questionnaire includes items on spasticity, anxiety, pain, social interaction and joy.
The support person assess the patients' level of spasticity, anxiety, pain, social interaction and joy three times: before, during and after each session.
Each item is assessed on a five-point Likert scale, from 'not at all present' (1) to 'present all the time' (5).
The research group has developed the questionnaire.
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12 weeks
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Quality of Life assessment: EQ5D
Time Frame: 14 weeks
|
Quality of life was assessed using the proxy version of the EuroQol Five Dimension (EQ5D).
The EQ5D is divided into five items: mobility, self-care, Daily activities, pain and discomfort, anxiety and depression.
The items are scored on a 5 point scale, as well as a visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health).
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14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior
Time Frame: 12 weeks
|
Video assisted observation.
Each person will be video recorded in the pool on three occasions (1st, 6th and 12th session).
The responsible intervention leader and the project coordinator perform the video recording.
From the video recordings, assessments are made of the patient's expression of emotions and social interaction, through a structured assessment protocol developed by the research group.
The video material is transferred to the computer and encoded according to a pre-established protocol using a computer program-coding tool.
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12 weeks
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Goal attainment
Time Frame: 14 weeks
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We use the Goal Attainment Scaling (GAS), which provides an individualized, criterion-referenced measure of change.
The GAS procedure involves: (a) defining a unique set of goals for each participant, (b) specifying a range of possible outcomes for each goal (on a scale recommended to contain five levels, from -2 (the participants baseline level before the intervention) to +2(represent much better than expected after the intervention) and (c) using the scale to evaluate the participants change after a specified intervention period.
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14 weeks
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Muscular pain
Time Frame: 12 weeks
|
Observed (video).Each person will be video recorded in the pool on three occasions (1st, 6th and 12th session).
The video recording is performed by the responsible intervention leader and the project coordinator.
From the video recordings, assessments are made of the patient's expression of pain, through a structured assessment protocol developed by the research group.
The video material is transferred to the computer and encoded according to a pre-established protocol using a computer program-coding tool.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience of implementation of study intervention
Time Frame: 2 years
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Interviews with assistants, intervention leaders and head of organisations.
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mats G Karlsson, Professor, Region Örebro County
Publications and helpful links
General Publications
- Lundqvist LO, Materne M, Frank A, Morelius E, Duberg A. Salivary cortisol levels and stress in adults with profound intellectual and multiple disabilities participating in the Structured Water Dance Intervention: a randomised controlled crossover trial. Sci Rep. 2022 Oct 19;12(1):17418. doi: 10.1038/s41598-022-21573-x.
- Granberg A, Materne M, Lundqvist LO, Duberg A. Navigating change - managers' experience of implementation processes in disability health care: a qualitative study. BMC Health Serv Res. 2021 Jun 10;21(1):571. doi: 10.1186/s12913-021-06570-6.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18RS788/RÖL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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