A Water-based Sequential Preparatory Approach and Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362202
• Other study ID #: FSLCE/PROG.728
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2020
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Water-based Sequential Preparatory Approach
The experimental training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises followed 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). The control aquatic therapy consists of water-based exercises, in line with suggestions of the Hydrotherapy Association of Chartered Physiotherapists Guidance on Good Practice in Hydrotherapy. These consisted of warm-up exercises, stretching exercises for the lower limbs, recruitment exercises and walking exercises during each phase of gait (single stance, swing and double stance).

Locations

Country	Name	City	State
Italy	Santa Lucia Foundation I.R.C.C.S.	Roma	Rm

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Berg Balance Scale 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	at 2 months
Secondary	Stroke Specific Quality Of Life Scale (SS-QOL)	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.	baseline, after 4 weeks of training, and 4 weeks after the end of training
Secondary	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.	baseline, after 4 weeks of training, and 4 weeks after the end of training
Secondary	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.	baseline, after 4 weeks of training, and 4 weeks after the end of training
Secondary	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.	baseline, after 4 weeks of training, and 4 weeks after the end of training