Traumatic Brain InjuryNCT04383405
Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury
A study testing Aquatic Training and Conventional Training in people with Traumatic Brain Injury and Severe Traumatic Brain Injury, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially considering high-income countries. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Severe Traumatic Brain Injury
- What is being tested?
- Aquatic Training and Conventional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 2 May 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age between 15 and 65 years;
- Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
- level of cognitive functioning (LCF) ≥7;
- ability to understand verbal commands.
- acclimatization to water.
Who cannot join
- Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination > 24);
- Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
- Severe aphasia (diagnosed by means of neuropsychological assessment);
- Presence of other neurological diseases;
- Presence of cutaneous and mycosis infections;
- Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;
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- Presence of PEG (Percutaneous endoscopic gastrostomy);
- Presence of tracheostomy;
- Urinary incontinence;
- Presence of otitis
- Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aquatic Therapy During Post-acute Intensive Neurorehabilitation in Patients With Severe Traumatic Brain Injury: a Preliminary Randomized Controlled Trial
Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially considering high-income countries.
The TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can involve physical, cognitive, behavioural and emotional functioning limiting everyday life and social activities and leading to a lowers quality of life.
a sequential preparatory approach (SPA), performed in aquatic environment, based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex) could be an effective complementary training during post-acute intensive rehabilitation in patients with severe traumatic brain injury (sTBI).
- Being tested
- Aquatic Training, Conventional Training
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic TrainingOther
Aquatic Training training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises follow a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e. catching a ball thrown by the therapist). Subjects performed three sessions a week for four weeks and each session lasting 45 minutes. The training was carried out by a physiotherapist who had at least 5 years of experience in aquatic neurorehabilitation.
Conventional TrainingOther
Conventional land-based therapy consists of customized exercises focused on static and dynamic postural stability improvement. The exercises included the active-assisted mobilization, the muscle stretching the postural transition, the balance and the gait training. The control approach was carried out three times a week for four weeks and each session lasted 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Preparotory Approach | Experimental | Not described Receives: Other: Aquatic Training |
| Conventional | Active comparator | Not described Receives: Other: Conventional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berg Balance Scale (BBS) at 1month
Change of Berg Balance Scale (BBS) from baseline at 1 month. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest
Measured: 1 month
Secondary outcomes (5)
Tinetti Balance and Gait Scale (TBG)
Change of Tinetti Balance and Gait Scale (TBG) from baseline at 4 weeks of training and at 4 weeks after the end of the training. TBG values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one.
Measured: baseline and after 4 weeks of training
Modified Barthel Index (MBI)
Change of Modified Barthel Index (MBI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one.
Measured: baseline and after 4 weeks of training
Modified Ashworth Scale (MAS)
Change of Modified Ashworth Scale (MAS) from baseline at 4 weeks of the training and at 4 weeks after the end of the training. MAS values ranging from 0 to 5, where 0 means the best outcome and 5 the worse one.
Measured: baseline and after 4 weeks of training
Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI)
Change of proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. (Proxy-QOLIBRI) values ranging from 0 to 100, where 0 means the worse outcome and 100 the best one.
Measured: baseline and after 4 weeks of training
Disability Rating Scale (DRS)
Measure of function after TBI intended to measure function from "coma to community." Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability).
Measured: baseline and after 4 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Sep 2019
- Primary completion19 Apr 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383405
- Sponsor's protocol ID
- CE/PROG775/2019SPA
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Therapy During Post-acute Intensive Neurorehabilitation in Patients With Severe Traumatic Brain Injury: a Preliminary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04383405
- Acronym / sponsor ID
- CE/PROG775/2019SPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 12 May 2020 (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.
Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially considering high-income countries.
The TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can involve physical, cognitive, behavioural and emotional functioning limiting everyday life and social activities and leading to a lowers quality of life.
a sequential preparatory approach (SPA), performed in aquatic environment, based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex) could be an effective complementary training during post-acute intensive rehabilitation in patients with severe traumatic brain injury (sTBI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Preparotory Approach | Experimental | Other: Aquatic Training |
| Conventional | Active comparator | Other: Conventional Training |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age between 15 and 65 years;
- Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
- level of cognitive functioning (LCF) ≥7;
- ability to understand verbal commands.
- acclimatization to water.
Key exclusion criteria (11 listed)
- Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination > 24);
- Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
- Severe aphasia (diagnosed by means of neuropsychological assessment);
- Presence of other neurological diseases;
- Presence of cutaneous and mycosis infections;
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 |
|---|---|---|
| Aquatic TrainingAquatic Training training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises follow a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e. catching a ball thrown by the therapist). Subjects performed three sessions a week for four weeks and each session lasting 45 minutes. The training was carried out by a physiotherapist who had at least 5 years of experience in aquatic neurorehabilitation. | Other | Sequential Preparotory Approach |
| Conventional TrainingConventional land-based therapy consists of customized exercises focused on static and dynamic postural stability improvement. The exercises included the active-assisted mobilization, the muscle stretching the postural transition, the balance and the gait training. The control approach was carried out three times a week for four weeks and each session lasted 45 minutes. | Other | Conventional |
Primary outcome
Change in Berg Balance Scale (BBS) at 1month
Time frame: 1 month
Change of Berg Balance Scale (BBS) from baseline at 1 month. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest
5 secondary outcomes
Tinetti Balance and Gait Scale (TBG)
Time frame: baseline and after 4 weeks of training
Modified Barthel Index (MBI)
Time frame: baseline and after 4 weeks of training
Modified Ashworth Scale (MAS)
Time frame: baseline and after 4 weeks of training
Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI)
Time frame: baseline and after 4 weeks of training
Disability Rating Scale (DRS)
Time frame: baseline and after 4 weeks of training
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 12 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Training and Conventional Training in people with Traumatic Brain Injury and Severe Traumatic Brain Injury, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
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 5 inclusion and 11 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 12 May 2020. 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 Italy. 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?
Change in Berg Balance Scale (BBS) at 1month (time frame: 1 month). 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 12 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.