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Evaluation of Specialized Water Dance Intervention (SWAN)

Primary Purpose

Spastic, Pain, Chronic, Stress

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Specialized water dance intervention
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spastic

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Care Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Specialized water dance intervention

No intervention

Outcomes

Primary Outcome Measures

Stress
Cortisol in saliva
Spasticity
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.
Wellbeing: Observed (questionnaire)
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.
Quality of Life assessment: EQ5D
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).

Secondary Outcome Measures

Behavior
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.
Goal attainment
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.
Muscular pain
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.

Full Information

First Posted
March 19, 2019
Last Updated
September 14, 2021
Sponsor
Region Örebro County
Collaborators
Region Gävleborg, Värmland County Council, Sweden, Region Östergötland
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1. Study Identification

Unique Protocol Identification Number
NCT03908801
Brief Title
Evaluation of Specialized Water Dance Intervention
Acronym
SWAN
Official Title
Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
Region Gävleborg, Värmland County Council, Sweden, Region Östergötland

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic, Pain, Chronic, Stress, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The participants are first randomized to the intervention or control group and when the intervention for the first group is completed, the intervention is given to the second group (former control group). Since the prevalence of profound intellectual and multiple disabilities is low, the project is carried out as a multicenter study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Specialized water dance intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Specialized water dance intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stress
Description
Cortisol in saliva
Time Frame
14 weeks
Title
Spasticity
Description
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.
Time Frame
14 weeks
Title
Wellbeing: Observed (questionnaire)
Description
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.
Time Frame
12 weeks
Title
Quality of Life assessment: EQ5D
Description
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).
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Behavior
Description
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.
Time Frame
12 weeks
Title
Goal attainment
Description
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.
Time Frame
14 weeks
Title
Muscular pain
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Experience of implementation of study intervention
Description
Interviews with assistants, intervention leaders and head of organisations.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats G Karlsson, Professor
Organizational Affiliation
Region Örebro County
Official's Role
Study Chair
Facility Information:
Facility Name
University Health Care Research Center
City
Örebro
ZIP/Postal Code
70182
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36261594
Citation
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.
Results Reference
derived
PubMed Identifier
34112151
Citation
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.
Results Reference
derived
Links:
URL
https://www.researchweb.org/is/fourol/project/240151
Description
Description of the SWAN project

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Evaluation of Specialized Water Dance Intervention

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