A Water-based Sequential Preparatory Approach and Stroke

NCT04362202 | Completed

• 1 other identifier: FSLCE/PROG.728
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Stroke Specific Quality Of Life Scale (SS-QOL)

  baseline, after 4 weeks of training, and 4 weeks after the end of training

• Modified Barthel Index (MBI)

  baseline, after 4 weeks of training, and 4 weeks after the end of training

• Tinetti Balance and Gait Scale (TBG)

  baseline, after 4 weeks of training, and 4 weeks after the end of training

• Modified Ashworth Scale (MAS)

  baseline, after 4 weeks of training, and 4 weeks after the end of training

Study Arms (2)

experimental

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.

Other: Water-based Sequential Preparatory Approach

control

ACTIVE COMPARATOR

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.

Other: Water-based Sequential Preparatory Approach

Interventions

Water-based Sequential Preparatory Approach 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; experimental

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

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

Roma, Rm, 00179, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marco Tramontano

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Services

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: February 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

IT (1)