- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03251209
Mental Practice in Post-stroke Subjects
August 15, 2017 updated by: Roberta de Oliveira Cacho, Universidade Federal do Rio Grande do Norte
Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae
Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes changes that limit the individual in his ability to maintain an active social life.
Mental Practice (MP) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already known skill.
The objective of the study is evaluate the effects of the physical practice associated with PM, on paretic MS.
Subjects with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be selected.
Subjects with painful conditions that affected exercise performance,> 3 spasticity by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be excluded.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
There are 3 study protocols.
The MP protocol 1 comprise 4 steps: 1) 5 minutes of global relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes / task.
4) Physical Practice: reproduce through the motor execution, the activities assisted in the video (5 minutes / task).
The MP protocol 2 was the same, changing the order: first physical practice and after MP.
For the protocol 3 without PM, step 3 was suppressed, remaining the remaining steps.
There were 15 sessions, 2x / week, for 1 hour.
The Fugl-Meyer (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be applied before and after the sessions, and in 3 months follow-up.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Norte
-
Santa Cruz, Rio Grande do Norte, Brazil, 59200000
- Faculty of Health Science - Facisa/UFRN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects
Exclusion Criteria:
- Painful conditions that affect the ability to perform the proposed exercises, spasticity greater than 3 by the Ashworth Scale and cognitive deficits that will be evaluated by the Mini Mental State Examination (MMSE)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Post-stroke participants receive the mental practice before the physical practice.
The activities will be presented in a videotherapy way.
|
Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).
Mental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task.
Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)
|
|
Experimental: Group 2
Post-stroke participants receive the mental practice after the physical practice.
The activities will be presented in a videotherapy way.
|
Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).
Mental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task.
Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)
|
|
Active Comparator: Group 3
Post-stroke participants receive only physical practice.
The activities will be presented in a videotherapy way.
|
Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).
Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Scale
Time Frame: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
|
Sensory-motor impairment of upper limb
|
Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
|
|
surface electromyography
Time Frame: change from baseline muscle activity at 8 weeks and 3 months (follow-up)
|
Short radial extensor of the carpus and superficial flexor of the fingers
|
change from baseline muscle activity at 8 weeks and 3 months (follow-up)
|
|
Functional independence measure (FIM)
Time Frame: change from baseline functional independence at 8 weeks and 3 months (follow-up)
|
assess the dependence of others for activities of daily living
|
change from baseline functional independence at 8 weeks and 3 months (follow-up)
|
|
Action Research Arm Test (ARAT)
Time Frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)
|
functional test of upper limb
|
change from baseline dexterity at 8 weeks and 3 months (follow-up)
|
|
Box and Block test (BBT)
Time Frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)
|
manual dexterity
|
change from baseline dexterity at 8 weeks and 3 months (follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Imagery Questionnaire-Revised second version (MIQ-RS)
Time Frame: change from baseline ability to imagine at 8 weeks
|
evaluate the ability to imagine thick movements related to the upper and include movements referring to the ADLs.
|
change from baseline ability to imagine at 8 weeks
|
|
Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)
Time Frame: change from baseline capacity of imagination at 8 weeks
|
assessing visual and kinesthetic motor imagery
|
change from baseline capacity of imagination at 8 weeks
|
|
Mini-mental State Examination
Time Frame: baseline
|
evaluation of cognition
|
baseline
|
|
Theory of Mind Task Battery (ToM)
Time Frame: change from mental function baseline at 8 weeks
|
evaluation of mental function
|
change from mental function baseline at 8 weeks
|
|
Modified ashworth scale (MAS)
Time Frame: change fom baseline muscle tone at 8 weeks and 3 months (follow-up)
|
evaluation of muscle tone of upper limb
|
change fom baseline muscle tone at 8 weeks and 3 months (follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
June 10, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 15, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
August 16, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.978.586/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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