NCT03908801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

September 21, 2021

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

March 19, 2019

Last Update Submit

September 14, 2021

Conditions

SpasticPain, ChronicStressQuality of Life

Outcome Measures

Primary Outcomes (4)

  • Stress

    Cortisol in saliva

    14 weeks

  • 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

  • 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

  • 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 Outcomes (3)

  • Behavior

    12 weeks

  • Goal attainment

    14 weeks

  • Muscular pain

    12 weeks

Other Outcomes (1)

  • Experience of implementation of study intervention

    2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Specialized water dance intervention

Behavioral: Specialized water dance intervention

Control

NO INTERVENTION

No intervention

Interventions

Specialized water dance interventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • severe hearing impairment/deafness
  • have wounds/infections that are infectious in the pool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Care Research Center

Örebro, 70182, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 36261594DERIVED

  • 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.

    PMID: 34112151DERIVED

Related Links

MeSH Terms

Conditions

Muscle SpasticityChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Study Officials

  • Mats G Karlsson, Professor

    Region Örebro County

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

April 9, 2019

Study Start

September 1, 2018

Primary Completion

September 30, 2020

Study Completion

December 11, 2020

Last Updated

September 21, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)