Clinical trial NCT04362202: A Water-based Sequential Preparatory Approach and Stroke
Official title: A Water-based Sequential Preparatory Approach Versus Conventional Aquatic Training in Stroke Patients: a Randomized Controlled Trial With a One-month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 33
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living.

A Cochrane Review systematically synthesized and compared the effects of aquatic and land-based therapies on the activities of daily living (ADL) of patients following stroke and found that water-based exercises improved strength and ADL. A recent review indicates that RCTs comparing aquatic methods in both environments are lacking. The same movements in water and on dry land that target postural stability and gait require different competences. For example, the postural instability that occurs while squatting in water was enacted on land by sitting on a therapy ball. Furthermore, land-based conventional rehabilitation is generally task oriented, customized and challenging and follows a specific preparatory sequence of exercises according to patients' disabilities. Therefore, the investigators believe that a sequential preparatory approach (SPA), based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex), should also be used in an aquatic environment.


Eligibility criteria: Inclusion Criteria:

* Stroke with unilateral hemiplegia within the previous six months;
* Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance (Functional Ambulation Classification ≥ 3);
* Acclimatization to water.

Exclusion criteria:

* 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;
* 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).

Primary outcomes:
measure: Change in Berg Balance Scale at 2 months
timeFrame: at 2 months
Secondary outcomes:
measure: Stroke Specific Quality Of Life Scale (SS-QOL)
timeFrame: baseline, after 4 weeks of training, and 4 weeks after the end of training
measure: Modified Barthel Index (MBI)
timeFrame: baseline, after 4 weeks of training, and 4 weeks after the end of training
measure: Tinetti Balance and Gait Scale (TBG)
timeFrame: baseline, after 4 weeks of training, and 4 weeks after the end of training
measure: Modified Ashworth Scale (MAS)
timeFrame: baseline, after 4 weeks of training, and 4 weeks after the end of training
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Santa Lucia Foundation I.R.C.C.S.
state: Rm
Study officials:
affiliation: Santa Lucia Foundation I.R.C.C.S.
name: Marco Tramontano
role: PRINCIPAL_INVESTIGATOR
References: