Brain-injuryNCT05151497
Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick
A study testing Experimental group:Halliwick + Método Watsu in people with Brain-injury, run by University of Cadiz at 3 sites in Spain.
Trial summary
Treatment with ACD patients will be carried out through the application of aquatic therapies, being the Halliwick Concept and the Watsu Method together with a time of immersion in hot water. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain-injury
- What is being tested?
- Experimental group:Halliwick + Método Watsu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesSpain
- Study dates
- 20 Oct 2021to 15 Jan 2022
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Belonging to the Acquired Brain Injury Association of Cádiz
- Presence of spasticity in the biceps brachii and soleus muscles confirmed by the modified Ashworth Scale and modified Tardieu Scale.
- Patients who are standing and walking at least with technical assistance and / or supervision.
- Patients with acquired brain damage and with spastic hemiparesis with a chronic evolution of more than 12 months.
Who cannot join
- Presence of infections.
- Other diagnosed diseases that prevent aquatic physiotherapy treatment, such as uncontrolled diabetes or dyspnea at rest.
- Have received aquatic therapy treatment in the six months prior to the study with the methods developed in the study (Halliwick or Watsu).
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Miriam García Blanco
Cadiz, Cádiz, 11008
Miriam García Blanco, Máster, 956019000, miriamgblanco@hotmail.com
Miriam García Blanco
- Recruiting
Asociación de Daño Cerebral de Cádiz (ADACCA)
Cadiz, Cádiz, 11011
Miriam García Blanco, Máster, 956019000, miriamgblanco@hotmail.com
Miriam García Blanco, master
- Recruiting
University of Cadiz
Cadiz, 11008
Miriam García Blanco, Máster, 956019000, miriamgblanco@hotmail.com
About this study
Treatment with ACD patients will be carried out through the application of aquatic therapies, being the Halliwick Concept and the Watsu Method together with a time of immersion in hot water.
Read the detailed description
The study consists of verifying the efficacy of physiotherapeutic treatment through the use of aquatic therapies, Watsu and Halliwick in subjects who have suffered Acquired Brain Injury (ACD), and who, after that, present spasticity. For this, the users of the Brain Injury Association of Cádiz (ADACCA) are taken as references.
Brain damage is a brain injury, resulting in a series of functional and neurological alterations. The treatment of this pathology will be carried out through the application of aquatic teràpies, being the Halliwick Concept and the Watsu Method.
This study consists of a clinical trial where the experimental group will be applied the combined treatment of Halliwick and Watsu together with a time of immersion in hot water, and to the control group the treatment by Halliwick plus immersion in hot water, in order to evaluate the degree of spasticity they present at the end of the study.
- Conditions
- Brain-injury
- Being tested
- Experimental group:Halliwick + Método Watsu, Control group:Halliwick
- Keywords
- Acquired brain damage, aquatic therapy, hemiparesis, spasticity
- Medical subject headings
- Brain Injuries, Paresis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group:Halliwick + Método WatsuOther
Carrying out the Ten Points Program through the Halliwick Concept, together with the Watsu Method through a series of relaxation maneuvers and mobilization of the body in float, and an immersion time of 15 minutes without doing physical activity in a pool at a temperature of 30ºC , to decrease spasticity of various muscles.
Control group:HalliwickOther
Exclusive use of treatment through the Halliwick Concept Ten Point Program, along with immersion in hot water to reduce spasticity in various muscles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Halliwick + Método Watsu | Experimental | The experimental group is made up of 7 subjects, the duration of the session being 75 minutes, divided into 45 minutes of Halliwick, 15 minutes of Watsu and finally 15 minutes of immersion in hot water. .
In the application of the Halliwick Concept, it will be carried out in a pool at a temperature of 30ºC, and through the Ten Points Program.
To carry out Watsu, the pool water must be at a temperature of 35ºC. The Watsu Basic Maneuver will be performed, consisting of a sequence of various positions where the subject must be as relaxed as possible, placed in a supine position, floating with eyes closed, and supported by the physiotherapist who is standing, with a wide base of support. Receives: Other: Experimental group:Halliwick + Método Watsu |
| Control group:Halliwick | Active comparator | The control group is made up of 7 subjects, the duration of the session being 75 minutes, divided into 60 minutes of Halliwick and 15 minutes of immersion in hot water. Treatment using the Halliwick Concept is carried out in a pool where the water temperature is 30ºC, following the Ten Points Program. Receives: Other: Control group:Halliwick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Asworth
0 (no increase in muscle tone) to 4 (rigid part in flex-ext)
1 = Left
Measured: Change from Baseline at 8 weeks
Modified Tardieu
0 (no resistance to movement) to 4 (10 second clonus)
Measured: Change from Baseline at 8 weeks
Medical Outcome Study-Sleep Scale
Sleep rating (1 = more trouble falling asleep, a 6 = least trouble sleeping.
Measured: Change from Baseline al 8 weeks
Number of years-Age
Years
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start20 Oct 2021
- Primary completion27 Dec 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain-injuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam García Blanco, University of Cadiz
- Investigators
- Miriam García Blanco, Máster, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151497
- Sponsor's protocol ID
- Universitiy of Cádiz
- Status last verified
- Dec 2021
- First submitted
- 23 Oct 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick
- ClinicalTrials.gov ID
- NCT05151497
- Acronym / sponsor ID
- Universitiy of Cádiz
- Conditions
- Brain-injury
- Keywords
- Acquired brain damage, aquatic therapy, hemiparesis, spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 27 Dec 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
Treatment with ACD patients will be carried out through the application of aquatic therapies, being the Halliwick Concept and the Watsu Method together with a time of immersion in hot water.
Detailed description
The study consists of verifying the efficacy of physiotherapeutic treatment through the use of aquatic therapies, Watsu and Halliwick in subjects who have suffered Acquired Brain Injury (ACD), and who, after that, present spasticity. For this, the users of the Brain Injury Association of Cádiz (ADACCA) are taken as references.
Brain damage is a brain injury, resulting in a series of functional and neurological alterations. The treatment of this pathology will be carried out through the application of aquatic teràpies, being the Halliwick Concept and the Watsu Method.
This study consists of a clinical trial where the experimental group will be applied the combined treatment of Halliwick and Watsu together with a time of immersion in hot water, and to the control group the treatment by Halliwick plus immersion in hot water, in order to evaluate the degree of spasticity they present at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Halliwick + Método Watsu | Experimental | Other: Experimental group:Halliwick + Método WatsuThe experimental group is made up of 7 subjects, the duration of the session being 75 minutes, divided into 45 minutes of Halliwick, 15 minutes of Watsu and finally 15 minutes of immersion in hot water. . In the application of the Halliwick Concept, it will be carried out in a pool at a temperature of 30ºC, and through the Ten Points Program. To carry out Watsu, the pool water must be at a temperature of 35ºC. The Watsu Basic Maneuver will be performed, consisting of a sequence of various positions where the subject must be as relaxed as possible, placed in a supine position, floating with eyes closed, and supported by the physiotherapist who is standing, with a wide base of support. |
| Control group:Halliwick | Active comparator | Other: Control group:HalliwickThe control group is made up of 7 subjects, the duration of the session being 75 minutes, divided into 60 minutes of Halliwick and 15 minutes of immersion in hot water. Treatment using the Halliwick Concept is carried out in a pool where the water temperature is 30ºC, following the Ten Points Program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Belonging to the Acquired Brain Injury Association of Cádiz
- Presence of spasticity in the biceps brachii and soleus muscles confirmed by the modified Ashworth Scale and modified Tardieu Scale.
- Patients who are standing and walking at least with technical assistance and / or supervision.
- Patients with acquired brain damage and with spastic hemiparesis with a chronic evolution of more than 12 months.
Key exclusion criteria (3 listed)
- Presence of infections.
- Other diagnosed diseases that prevent aquatic physiotherapy treatment, such as uncontrolled diabetes or dyspnea at rest.
- Have received aquatic therapy treatment in the six months prior to the study with the methods developed in the study (Halliwick or Watsu).
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 |
|---|---|---|
| Experimental group:Halliwick + Método WatsuCarrying out the Ten Points Program through the Halliwick Concept, together with the Watsu Method through a series of relaxation maneuvers and mobilization of the body in float, and an immersion time of 15 minutes without doing physical activity in a pool at a temperature of 30ºC , to decrease spasticity of various muscles. | Other | Experimental group: Halliwick + Método Watsu |
| Control group:HalliwickExclusive use of treatment through the Halliwick Concept Ten Point Program, along with immersion in hot water to reduce spasticity in various muscles. | Other | Control group:Halliwick |
Primary outcome
Modified Asworth
Time frame: Change from Baseline at 8 weeks
0 (no increase in muscle tone) to 4 (rigid part in flex-ext) 1 = Left
Modified Tardieu
Time frame: Change from Baseline at 8 weeks
0 (no resistance to movement) to 4 (10 second clonus)
Medical Outcome Study-Sleep Scale
Time frame: Change from Baseline al 8 weeks
Sleep rating (1 = more trouble falling asleep, a 6 = least trouble sleeping.
Number of years-Age
Time frame: Baseline
Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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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.
Miriam García Blanco, Máster principal investigator
University of Cadiz
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group:Halliwick + Método Watsu in people with Brain-injury, run by University of Cadiz at 3 sites in Spain.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam García Blanco, Máster (956019000, miriamgblanco@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Asworth (time frame: Change from Baseline at 8 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?
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 14 Dec 2021.