A Water-based Sequential Preparatory Approach and Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Water-based Sequential Preparatory Approach

• Registration Number: NCT04362202
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-11-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Water-based Sequential Preparatory Approach	8 individual experimental rehabilitation sessions as outpatients (2 days/week, 4 weeks), in a rehabilitation pool at Fondazione Santa Lucia Neurorehabilitation hospital. Each session lasted 45minutes. The water temperature was between 30°C and 32°C.
control	Water-based Sequential Preparatory Approach	8 individual of standard aquatic rehabilitation sessions as outpatients (2 days/week, 4 weeks), in a rehabilitation pool at Fondazione Santa Lucia Neurorehabilitation hospital. Each session lasted 45minutes. The water temperature was between 30°C and 32°C.

Primary Outcome Measures

Name	Time	Method
Change in Berg Balance Scale at 2 months	at 2 months	Change of Berg Balance Scale (BBS) from baseline at 2 months. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest

Secondary Outcome Measures

Name	Time	Method
Stroke Specific Quality Of Life Scale (SS-QOL)	baseline, after 4 weeks of training, and 4 weeks after the end of training	Change of Stroke Specific Quality Of Life Scale (SS-QOL) from baseline at 4 weeks of training and at 4 weeks after the end of the training. SS-QOL values ranging from 0 to 245, where 0 means the worse outcome and 245 the best one.
Modified Barthel Index (MBI)	baseline, after 4 weeks of training, and 4 weeks after the end of training	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.
Tinetti Balance and Gait Scale (TBG)	baseline, after 4 weeks of training, and 4 weeks after the end of training	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.
Modified Ashworth Scale (MAS)	baseline, after 4 weeks of training, and 4 weeks after the end of training	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.

Trial Locations

Locations (1)

Santa Lucia Foundation I.R.C.C.S.; 🇮🇹 Roma, Rm, Italy