Back to resultsEffects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke
Primary Purpose
Stroke, Hydrotherapy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
circuit class therapy in water
circuit class therapy on land
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring circuit class therapy, ICF model, aquatic therapy, neuro-rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
- age ≥18 to ≤ 90;
- provide a written informed consent;
- able to walk for at least 10 m without assistance
Exclusion Criteria:
- patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
- with infectious diseases, ulcers or urinary and / or faecal incontinence;
- additional neurological and / or orthopedic deficits that alter ambulation;
- unable to follow treatment (cognitive, visual ...).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
circuit class therapy in water
circuit class therapy on land
Arm Description
CCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.
CCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.
Outcomes
Primary Outcome Measures
10 meters walk test
Secondary Outcome Measures
Test Up & Go
Berg Balance Scale (BBS)
Romberg Test
Fugl-Meyer Assessment
Functional Reach Test (FRT)
Box and block test
Self-efficacy Scale
Activities-Specific Balance Confidence Scale (ABC)
Full Information
NCT ID
NCT02999971
First Posted
December 18, 2016
Last Updated
March 30, 2020
Sponsor
Universidade da Coruña
1. Study Identification
Unique Protocol Identification Number
NCT02999971
Brief Title
Effects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke
Official Title
Effects of an Aquatic Circuit Class Therapy Program Versus a Land Circuit Class Therapy Program in Patients Who Suffered a Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity
Detailed Description
This study is a randomized controlled trial of the effectiveness of a structured CCT program in water versus a structured CCT program on land in the rehabilitation of stroke survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hydrotherapy
Keywords
circuit class therapy, ICF model, aquatic therapy, neuro-rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
circuit class therapy in water
Arm Type
Experimental
Arm Description
CCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.
Arm Title
circuit class therapy on land
Arm Type
Experimental
Arm Description
CCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.
Intervention Type
Other
Intervention Name(s)
circuit class therapy in water
Intervention Description
The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
Intervention Type
Other
Intervention Name(s)
circuit class therapy on land
Intervention Description
The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
Primary Outcome Measure Information:
Title
10 meters walk test
Time Frame
60 seconds
Secondary Outcome Measure Information:
Title
Test Up & Go
Time Frame
5 minutes
Title
Berg Balance Scale (BBS)
Time Frame
20 minutes
Title
Romberg Test
Time Frame
1 minute
Title
Fugl-Meyer Assessment
Time Frame
15 minutes
Title
Functional Reach Test (FRT)
Time Frame
10 minutes
Title
Box and block test
Time Frame
5 minutes
Title
Self-efficacy Scale
Time Frame
5 minutes
Title
Activities-Specific Balance Confidence Scale (ABC)
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
age ≥18 to ≤ 90;
provide a written informed consent;
able to walk for at least 10 m without assistance
Exclusion Criteria:
patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
with infectious diseases, ulcers or urinary and / or faecal incontinence;
additional neurological and / or orthopedic deficits that alter ambulation;
unable to follow treatment (cognitive, visual ...).
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke
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