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A Water-based Sequential Preparatory Approach and Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Water-based Sequential Preparatory Approach
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Santa Lucia Foundation I.R.C.C.S.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental

control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 22, 2020
Last Updated
April 23, 2020
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT04362202
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Water-based Sequential Preparatory Approach
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Berg Balance Scale at 2 months
Description
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
Time Frame
at 2 months
Secondary Outcome Measure Information:
Title
Stroke Specific Quality Of Life Scale (SS-QOL)
Description
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.
Time Frame
baseline, after 4 weeks of training, and 4 weeks after the end of training
Title
Modified Barthel Index (MBI)
Description
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.
Time Frame
baseline, after 4 weeks of training, and 4 weeks after the end of training
Title
Tinetti Balance and Gait Scale (TBG)
Description
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.
Time Frame
baseline, after 4 weeks of training, and 4 weeks after the end of training
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
baseline, after 4 weeks of training, and 4 weeks after the end of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Tramontano
Organizational Affiliation
Santa Lucia Foundation I.R.C.C.S.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Lucia Foundation I.R.C.C.S.
City
Roma
State/Province
Rm
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

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A Water-based Sequential Preparatory Approach and Stroke

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