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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999971
Other study ID # UCoruna
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date June 2019

Study information

Verified date March 2020
Source Universidade da Coruña
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date June 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 ...).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
circuit class therapy in water
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.
circuit class therapy on land
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade da Coruña

Outcome

Type Measure Description Time frame Safety issue
Primary 10 meters walk test 60 seconds
Secondary Test Up & Go 5 minutes
Secondary Berg Balance Scale (BBS) 20 minutes
Secondary Romberg Test 1 minute
Secondary Fugl-Meyer Assessment 15 minutes
Secondary Functional Reach Test (FRT) 10 minutes
Secondary Box and block test 5 minutes
Secondary Self-efficacy Scale 5 minutes
Secondary Activities-Specific Balance Confidence Scale (ABC) 10 minutes
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