SpasticSWANNCT03908801

Evaluation of Specialized Water Dance Intervention

A study testing Specialized water dance intervention in people with Spastic and Pain, Chronic, run by Region Örebro County at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 65 years
Conditions the study is for: Spastic, Pain, Chronic, Stress
What is being tested?: Specialized water dance intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSweden
Study dates: 1 Sep 2018to 11 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

University Health Care Research Center
Örebro, 70182

Other trials in Sweden

About this study

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

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.

Conditions: Spastic, Pain, Chronic, Stress, Quality of Life
Being tested: Specialized water dance intervention
Medical subject headings: Muscle Spasticity, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Specialized water dance interventionBehavioural
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.

Study groups in NCT03908801
Study group	Role	What they receive
Intervention	Experimental	Specialized water dance intervention Receives: Behavioral: Specialized water dance intervention
Control	No intervention	No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Stress
Cortisol in saliva
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 14 weeks

Secondary outcomes (3)

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.
Measured: 12 weeks
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.
Measured: 14 weeks
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201811 Dec 2020

First posted9 Apr 2019
Study start1 Sep 2018
Primary completion30 Sep 2020
Study completion11 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SpasticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03908801
Sponsor's protocol ID: 18RS788/RÖL
Acronym: SWAN
Status last verified: Oct 2020
First submitted: 19 Mar 2019
Last updated: 21 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36261594
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.
PubMed 34112151

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Specialized Water Dance Intervention (SWAN) for Individuals With Profound Intellectual and Multiple Disabilities: A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT03908801
Acronym / sponsor ID: SWAN / 18RS788/RÖL
Conditions: Spastic, Pain, Chronic, Stress, Quality of Life
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Region Örebro CountyUniversity, hospital or other
Collaborators: Region Gävleborg, Värmland County Council, Sweden, Region Östergötland
Study start: 1 Sep 2018 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 11 Dec 2020 (actual)
First posted: 9 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Intervention	Experimental	Behavioral: Specialized water dance interventionSpecialized water dance intervention
Control	No intervention	–No intervention

Who may qualify

Ages: 16 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Specialized water dance interventionGroup 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.	Behavioural	Intervention

Primary outcome

Stress
Time frame: 14 weeks
Cortisol in saliva
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.
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).

3 secondary outcomes

Behavior
Time frame: 12 weeks
Goal attainment
Time frame: 14 weeks
Muscular pain
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Derived from this study: PubMed 36261594Lundqvist 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.
Derived from this study: PubMed 34112151Granberg 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.
Description of the SWAN projectLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mats G Karlsson, Professor study chair

Region Örebro County

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Specialized water dance intervention in people with Spastic and Pain, Chronic, run by Region Örebro County at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress (time frame: 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03908801, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.