A Water-based Sequential Preparatory Approach and Stroke

NCT ID: NCT04362202

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-11-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental

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.

Group Type: EXPERIMENTAL

Water-based Sequential Preparatory Approach

Intervention Type: OTHER

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).

control

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.

Group Type: ACTIVE_COMPARATOR

Water-based Sequential Preparatory Approach

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role: lead

Responsible Party

Marco Tramontano

Head of Rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Tramontano

Role: PRINCIPAL_INVESTIGATOR

Santa Lucia Foundation I.R.C.C.S.

Locations

Santa Lucia Foundation I.R.C.C.S.

Roma, Rm, Italy

Countries

Italy

Other Identifiers

FSLCE/PROG.728

Identifier Type: -

Identifier Source: org_study_id