Mental Practice in Post-stroke Subjects

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03251209
• Other study ID #: 1.978.586/2017
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 7, 2017
• Last updated: August 15, 2017
• Start date: April 20, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 1, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

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).
• 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.
• 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)

Locations

Country	Name	City	State
Brazil	Faculty of Health Science - Facisa/UFRN	Santa Cruz	Rio Grande do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Scale	Sensory-motor impairment of upper limb	Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
Primary	surface electromyography	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)
Primary	Functional independence measure (FIM)	assess the dependence of others for activities of daily living	change from baseline functional independence at 8 weeks and 3 months (follow-up)
Primary	Action Research Arm Test (ARAT)	functional test of upper limb	change from baseline dexterity at 8 weeks and 3 months (follow-up)
Primary	Box and Block test (BBT)	manual dexterity	change from baseline dexterity at 8 weeks and 3 months (follow-up)
Secondary	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.	change from baseline ability to imagine at 8 weeks
Secondary	Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)	assessing visual and kinesthetic motor imagery	change from baseline capacity of imagination at 8 weeks
Secondary	Mini-mental State Examination	evaluation of cognition	baseline
Secondary	Theory of Mind Task Battery (ToM)	evaluation of mental function	change from mental function baseline at 8 weeks
Secondary	Modified ashworth scale (MAS)	evaluation of muscle tone of upper limb	change fom baseline muscle tone at 8 weeks and 3 months (follow-up)