Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Stress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Stress
Time Frame: 14 weeks
Cortisol in saliva
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).
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.
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.
Secondary Outcomes
- Goal attainment(14 weeks)
- Muscular pain(12 weeks)
- Behavior(12 weeks)