SWAN: Evaluation of Specialized Water Dance Intervention

Sponsor
Region Örebro County (Other)
Overall Status
Completed
CT.gov ID
NCT03908801
Collaborator
Region Gävleborg (Other), Värmland County Council, Sweden (Other), Region Östergötland (Other)
36
1
2
27.3
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Specialized water dance intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Other
Official Title:
Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Dec 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Specialized water dance intervention

Behavioral: 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.

No Intervention: Control

No intervention

Outcome Measures

Primary Outcome Measures

  1. Stress [14 weeks]

    Cortisol in saliva

  2. Spasticity [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.

  3. Wellbeing: Observed (questionnaire) [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.

  4. Quality of Life assessment: EQ5D [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).

Secondary Outcome Measures

  1. Behavior [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.

  2. Goal attainment [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.

  3. Muscular pain [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.

Other Outcome Measures

  1. Experience of implementation of study intervention [2 years]

    Interviews with assistants, intervention leaders and head of organisations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Care Research Center Örebro Sweden 70182

Sponsors and Collaborators

  • Region Örebro County
  • Region Gävleborg
  • Värmland County Council, Sweden
  • Region Östergötland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Region Örebro County
ClinicalTrials.gov Identifier:
NCT03908801
Other Study ID Numbers:
  • 18RS788/RÖL
First Posted:
Apr 9, 2019
Last Update Posted:
Sep 21, 2021
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2021