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Status unknownNCT03251209Updated Aug 16, 2017

Mental Practice in Post-stroke Subjects

An interventional study of Physical practice and Mental practice in Stroke Sequelae and Stroke, sponsored by Universidade Federal do Rio Grande do Norte. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke Sequelae
  • Stroke

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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 · Other: Mental practice · Other: Videotherapy

  • 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

  • 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

Interventions

  • OtherPhysical 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).

  • OtherMental 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.

  • OtherVideotherapy

    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)

05

What researchers measure

Primary outcomes

  1. Fugl-Meyer Scale

    Sensory-motor impairment of upper limb

    Time frame: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).

  2. surface electromyography

    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)

  3. Functional independence measure (FIM)

    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)

  4. Action Research Arm Test (ARAT)

    functional test of upper limb

    Time frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)

  5. Box and Block test (BBT)

    manual dexterity

    Time frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)

Secondary outcomes

  1. 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.

    Time frame: change from baseline ability to imagine at 8 weeks

  2. Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)

    assessing visual and kinesthetic motor imagery

    Time frame: change from baseline capacity of imagination at 8 weeks

  3. Mini-mental State Examination

    evaluation of cognition

    Time frame: baseline

  4. Theory of Mind Task Battery (ToM)

    evaluation of mental function

    Time frame: change from mental function baseline at 8 weeks

  5. Modified ashworth scale (MAS)

    evaluation of muscle tone of upper limb

    Time frame: change fom baseline muscle tone at 8 weeks and 3 months (follow-up)

06

Study locations

1 site
  • Faculty of Health Science - Facisa/UFRN
    Santa Cruz, Rio Grande do Norte 59200000, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03251209
Lead sponsor
Universidade Federal do Rio Grande do Norte
Responsible party
Roberta de Oliveira Cacho (PhD, Universidade Federal do Rio Grande do Norte) — Principal investigator
First posted
Aug 16, 2017
Start date
Apr 20, 2017
Primary completion
Jun 10, 2017
Completion
Dec 1, 2017 (estimated)
Last update
Aug 16, 2017

Study contacts

Roberta O Cacho, PhD
principal investigator · Universidade Federal do Rio Grande do Norte

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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