Clinical trial NCT03908801: Evaluation of Specialized Water Dance Intervention
Official title: Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic
Pain, Chronic
Stress
Quality of Life
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Region Gävleborg
name: Värmland County Council, Sweden
name: Region Östergötland
First posted: 2019-04-09
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Stress
timeFrame: 14 weeks
measure: Spasticity
timeFrame: 14 weeks
measure: Wellbeing: Observed (questionnaire)
timeFrame: 12 weeks
measure: Quality of Life assessment: EQ5D
timeFrame: 14 weeks
Secondary outcomes:
measure: Behavior
timeFrame: 12 weeks
measure: Goal attainment
timeFrame: 14 weeks
measure: Muscular pain
timeFrame: 12 weeks
Other outcomes:
measure: Experience of implementation of study intervention
timeFrame: 2 years
Locations:
city: Örebro
country: Sweden
facility: University Health Care Research Center
Study officials:
affiliation: Region Örebro County
name: Mats G Karlsson, Professor
role: STUDY_CHAIR
References:
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.
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.