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Mental Practice in Post-stroke Subjects

Primary Purpose

Stroke Sequelae, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical practice
Mental practice
Videotherapy
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Sequelae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of Health Science - Facisa/UFRN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.

Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.

Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way.

Outcomes

Primary Outcome Measures

Fugl-Meyer Scale
Sensory-motor impairment of upper limb
surface electromyography
Short radial extensor of the carpus and superficial flexor of the fingers
Functional independence measure (FIM)
assess the dependence of others for activities of daily living
Action Research Arm Test (ARAT)
functional test of upper limb
Box and Block test (BBT)
manual dexterity

Secondary Outcome Measures

Movement Imagery Questionnaire-Revised second version (MIQ-RS)
evaluate the ability to imagine thick movements related to the upper and include movements referring to the ADLs.
Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)
assessing visual and kinesthetic motor imagery
Mini-mental State Examination
evaluation of cognition
Theory of Mind Task Battery (ToM)
evaluation of mental function
Modified ashworth scale (MAS)
evaluation of muscle tone of upper limb

Full Information

First Posted
August 7, 2017
Last Updated
August 15, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03251209
Brief Title
Mental Practice in Post-stroke Subjects
Official Title
Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
June 10, 2017 (Actual)
Study Completion Date
December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

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
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way.
Intervention Type
Other
Intervention Name(s)
Physical practice
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Mental practice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Videotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Fugl-Meyer Scale
Description
Sensory-motor impairment of upper limb
Time Frame
Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
Title
surface electromyography
Description
Short radial extensor of the carpus and superficial flexor of the fingers
Time Frame
change from baseline muscle activity at 8 weeks and 3 months (follow-up)
Title
Functional independence measure (FIM)
Description
assess the dependence of others for activities of daily living
Time Frame
change from baseline functional independence at 8 weeks and 3 months (follow-up)
Title
Action Research Arm Test (ARAT)
Description
functional test of upper limb
Time Frame
change from baseline dexterity at 8 weeks and 3 months (follow-up)
Title
Box and Block test (BBT)
Description
manual dexterity
Time Frame
change from baseline dexterity at 8 weeks and 3 months (follow-up)
Secondary Outcome Measure Information:
Title
Movement Imagery Questionnaire-Revised second version (MIQ-RS)
Description
evaluate the ability to imagine thick movements related to the upper and include movements referring to the ADLs.
Time Frame
change from baseline ability to imagine at 8 weeks
Title
Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)
Description
assessing visual and kinesthetic motor imagery
Time Frame
change from baseline capacity of imagination at 8 weeks
Title
Mini-mental State Examination
Description
evaluation of cognition
Time Frame
baseline
Title
Theory of Mind Task Battery (ToM)
Description
evaluation of mental function
Time Frame
change from mental function baseline at 8 weeks
Title
Modified ashworth scale (MAS)
Description
evaluation of muscle tone of upper limb
Time Frame
change fom baseline muscle tone at 8 weeks and 3 months (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta O Cacho, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Science - Facisa/UFRN
City
Santa Cruz
State/Province
Rio Grande do Norte
ZIP/Postal Code
59200000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Mental Practice in Post-stroke Subjects

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