Evaluation of Specialized Water Dance Intervention

Quality of Life Clinical Trial

— SWAN  

Official title:

Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908801
• Other study ID #: 18RS788/RÖL
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 11, 2020

Study information

• Verified date: October 2020
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 11, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Quality of Life
• Spastic
• Stress

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.

Locations

Country	Name	City	State
Sweden	University Health Care Research Center	Örebro

Sponsors (4)

Lead Sponsor	Collaborator
Region Örebro County	Region Gävleborg, Region Östergötland, Värmland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experience of implementation of study intervention	Interviews with assistants, intervention leaders and head of organisations.	2 years
Primary	Stress	Cortisol in saliva	14 weeks
Primary	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.	14 weeks
Primary	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.	12 weeks
Primary	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).	14 weeks
Secondary	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.	12 weeks
Secondary	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.	14 weeks
Secondary	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.	12 weeks

External Links

•   Description of the SWAN project