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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00604747
Other study ID # 0038.0.254.000-05
Secondary ID 0038.0.254.000-0
Status Completed
Phase N/A
First received January 17, 2008
Last updated January 29, 2008
Start date August 2006
Est. completion date July 2007

Study information

Verified date January 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Background: The literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. However, this effect is not well known in post-stroke patients. Objective: The goal of this study was to investigate the effects of practice structure on motor learning in post-stroke patients. Methods: Participants included an experimental group (EG) of post-stroke patients: 17 males and females; and a control group (CG) of healthy individuals: 17 males and females. At the acquisition phase, all participants performed 30 trials of a coincident timing task. Nine individuals from each group practiced constantly (C) at a stimulus propagation speed of 3 mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph. Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05 (5%).


Description:

Utilized was Bassin's anticipation timer (Lafayette Instruments #50575), which is comprised of a control screen, one 1.52 m gutter with 32 diodes placed on it linearly, and a response button. The screen has a digital display, with commands that permit the operator to control the stimulus propagation speed and the preparatory interval speed. Once activated, the screen exhibits an alert signal, and, after the preparatory interval, it initiates the propagation of a luminous stimulus, lighting the 32 diodes successively. The task required participants to press the response button simultaneously with the illumination of the last diode. The digital display showed the error measure (em): that is, the difference between the illumination of the last diode and the response.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 62 Years
Eligibility Inclusion Criteria:

1. First cerebrovascular accident

2. Lesion covering the middle and the anterior cerebral artery territories

3. Presence of hemiplegia or hemiparesis

4. Mini-Mental State Examination (MMSE) score above 24 (19)

5. Sufficient attention and comprehension to perform the task

6. Absence of other associated neurological diseases.

Exclusion Criteria:

1. Acute medical problems

2. Uncorrected vision loss

3. Previous history of psychiatric admission

4. History of multiple strokes, transient ischemic attacks

5. Pathology of the less affected, ipsilateral to stroke upper extremity that would affect ability to perform the task

6. Score of 23 or less on the MMSE

7. Difficulty in comprehension of verbal command and simple instructions

8. Aphasia of comprehension.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Structure practice
there were 2 groups which received random practice and constant practice during acquisition phase

Locations

Country Name City State
Brazil Camila Torriani São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in performance during the acquisition; performance exhibited during the transfer phase was maintained during retention phases 1 and 2; and differences between the groups during the transfer phase and retention phases time in miliseconds No
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