Mental Practice in Post-stroke Subjects

Sponsor

Universidade Federal do Rio Grande do Norte (Other)

Overall Status

Unknown status

CT.gov ID

NCT03251209

Collaborator

(none)

Enrollment

Location

Arms

7.4

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Sequelae Stroke	Other: Physical practice Other: Mental practice Other: Videotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae

Actual Study Start Date :

Apr 20, 2017

Actual Primary Completion Date :

Jun 10, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.	Other: Physical practice 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). Other: Mental practice 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. Other: Videotherapy 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.	Other: Physical practice 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). Other: Mental practice 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. Other: Videotherapy 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.	Other: Physical practice 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). Other: Videotherapy 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)

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.

Other: Physical practice

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).

Other: Mental practice

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.

Other: Videotherapy

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.

Other: Physical practice

Other: Mental practice

Other: Videotherapy

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.

Other: Physical practice

Other: Videotherapy

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)

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Scale [Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).]
Sensory-motor impairment of upper limb
surface electromyography [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
Functional independence measure (FIM) [change from baseline functional independence at 8 weeks and 3 months (follow-up)]
assess the dependence of others for activities of daily living
Action Research Arm Test (ARAT) [change from baseline dexterity at 8 weeks and 3 months (follow-up)]
functional test of upper limb
Box and Block test (BBT) [change from baseline dexterity at 8 weeks and 3 months (follow-up)]
manual dexterity

Secondary Outcome Measures

Movement Imagery Questionnaire-Revised second version (MIQ-RS) [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.
Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10) [change from baseline capacity of imagination at 8 weeks]
assessing visual and kinesthetic motor imagery
Mini-mental State Examination [baseline]
evaluation of cognition
Theory of Mind Task Battery (ToM) [change from mental function baseline at 8 weeks]
evaluation of mental function
Modified ashworth scale (MAS) [change fom baseline muscle tone at 8 weeks and 3 months (follow-up)]
evaluation of muscle tone of upper limb

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Health Science - Facisa/UFRN	Santa Cruz	Rio Grande do Norte	Brazil	59200000

Sponsors and Collaborators

Universidade Federal do Rio Grande do Norte

Investigators

Principal Investigator: Roberta O Cacho, PhD, Universidade Federal do Rio Grande do Norte

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roberta de Oliveira Cacho, PhD, Universidade Federal do Rio Grande do Norte

ClinicalTrials.gov Identifier:

NCT03251209

Other Study ID Numbers:

1.978.586/2017

First Posted:

Aug 16, 2017

Last Update Posted:

Aug 16, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 16, 2017