Evaluation of Specialized Water Dance Intervention (SWAN)

September 14, 2021 updated by: Region Örebro County

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Örebro, Sweden, 70182
        • University Health Care Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
EXPERIMENTAL: Intervention
Specialized water dance intervention
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.

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.
12 weeks
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).
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.
12 weeks
Goal attainment
Time Frame: 14 weeks
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.
14 weeks
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience of implementation of study intervention
Time Frame: 2 years
Interviews with assistants, intervention leaders and head of organisations.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mats G Karlsson, Professor, Region Örebro County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

December 11, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (ACTUAL)

April 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

October 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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