NCT03251209

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

August 7, 2017

Last Update Submit

August 15, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Fugl-Meyer Scale

    Sensory-motor impairment of upper limb

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

  • 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)

  • 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)

  • Action Research Arm Test (ARAT)

    functional test of upper limb

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

  • Box and Block test (BBT)

    manual dexterity

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

Secondary Outcomes (5)

  • Movement Imagery Questionnaire-Revised second version (MIQ-RS)

    change from baseline ability to imagine at 8 weeks

  • Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)

    change from baseline capacity of imagination at 8 weeks

  • Mini-mental State Examination

    baseline

  • Theory of Mind Task Battery (ToM)

    change from mental function baseline at 8 weeks

  • Modified ashworth scale (MAS)

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

Study Arms (3)

Group 1

EXPERIMENTAL

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

Other: Physical practiceOther: Mental practiceOther: Videotherapy

Group 2

EXPERIMENTAL

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

Other: Physical practiceOther: Mental practiceOther: Videotherapy

Group 3

ACTIVE COMPARATOR

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

Other: Physical practiceOther: Videotherapy

Interventions

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).

Group 1Group 2Group 3

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.

Group 1Group 2

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)

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Science - Facisa/UFRN

Santa Cruz, Rio Grande do Norte, 59200000, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Roberta O Cacho, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 16, 2017

Study Start

April 20, 2017

Primary Completion

June 10, 2017

Study Completion

December 1, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations