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Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Zaqueline F. Guerra, Federal University of Juiz de Fora
Sponsor:
Information provided by (Responsible Party):
Zaqueline F. Guerra, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier:
NCT02540096
First received: September 1, 2015
Last updated: August 9, 2016
Last verified: August 2016
  Purpose

Stroke is a neurovascular event characterized by impaired blood supply to the brain due to rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and can affect individuals of any age and sex, being prevalent in the elderly population.

Among the main treatments available for stroke rehabilitation, most of them demands an appropriate structure and high-qualified personnel. Searching for more affordable treatment options, several studies suggest the use of mental practice with motor imagery as a potential therapeutic tool, since it can be performed at any place or any time the patient wishes, including their own homes.

Motor imagery can be defined as the covert cognitive process of imagining a movement of your own body(-part) without actually moving that body(-part).

Within this context, the objective of this study is to investigate the effects of mental practice for mobility, gait function and speed and muscle strength of the lower limb in subacute post-stroke hemiparesis.


Condition Intervention
Stroke
Hemiparesis
Other: Mental practice
Other: Cognitive training and Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Mental Practice for Mobility in Post-stroke Hemiparesis: Randomized Controlled Trial of Efficacy.

Further study details as provided by Zaqueline F. Guerra, Federal University of Juiz de Fora:

Primary Outcome Measures:
  • Change in Timed Up and Go (TUG) [ Time Frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention ]
    This is a measure that examines the participant's basic mobility skills by measuring seconds to rise from sitting, walk 3 meters, return, and sitting down

  • 5-Meter Walk Test [ Time Frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention ]
    This is a measure that examines the participant's gait speed (cut off 6 seconds)


Secondary Outcome Measures:
  • Change in Muscle strength [ Time Frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention ]
    Hand-held dynamometer (HDD) for measuring lower-limb muscle strength

  • Change in Quality of life [ Time Frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention ]
    Using World Health Organization Quality of Life Instrument (WHOQOL-Bref)

  • Change in Mental health [ Time Frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention ]
    Using Depression, anxiety and stress scale (DASS-21)

  • Change in TUG-ABS [ Time Frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention ]
    The Timed "Up and Go" Assessment of Biomechanical Strategies (TUG-ABS)


Estimated Enrollment: 70
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention (Mental Practice)
Participants will be submitted to individual and structured physiotherapy sessions (the same as the control groups). They will also participate in a structured mental practice session (lasting 30 minutes and three times a week), totaling 12 sessions at the end of this intervention.
Other: Mental practice
The sessions will be individualized and carried out in a peaceful setting.The aim of the mental practice protocol was to promote motor imagery of the following activities: get up from a chair and walk and sit, which enrolls the basic and instrumental activities of daily living. The sessions will consist of six steps: (1) "Physical Practice" (2) "Familiarization" (3) "Memory" (4) "Relaxation" (5) "Repeat" and (6) "post-practice mental relaxation". After the mental practice session, participants will be submitted to individual and structured physiotherapy sessions (the same as the control groups).
Placebo Comparator: Control group
Participants will be submitted to individual and structured physiotherapy sessions lasting 40 minutes. They will also participate in a cognitive training and relaxation session (lasting 30 minutes, three times a week), totaling 12 sessions.
Other: Cognitive training and Relaxation
Cognitive training and relaxation session (lasting 30 minutes, three times a week), totaling 12 sessions. The sessions will consist of calculations, memorization, imagination and body relaxation exercises. These sessions will not have any motor imagery. After the cognitive training and relaxation session, participants will be submitted to individual and structured physiotherapy sessions lasting 40 minutes with muscle strengthening and stretching exercises.

Detailed Description:

Post-stroke patients will be invited to participate after hospital discharge, based on inclusion and exclusion criteria. Then, after acceptance, participants will be randomized (block strategy) into two groups: Control group (Physiotherapy and Cognitive mental exercise) and Intervention group (Physiotherapy and Mental Practice group).

At baseline, 4 weeks (end of intervention) and 6 weeks, participants will be evaluated through the following tests: Timed-Up and Go test, 5-Meter Walk Test, TUG-ABS, WHOQOL-Bref, DASS-21 and muscle strength.

  Eligibility

Ages Eligible for Study:   18 Years to 73 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemiparesis after ischemic stroke (15 to 180 days after the event);
  • only one cerebral hemisphere affected;
  • no chemical, alcohol or drug dependency;
  • Score average ≥ 2,5 point in the instrument "Visual and Kinesthetic Imagery Questionnaire" (KIVQ-10);
  • No cognitive impairment (18 points in the Mini-Mental State Examination - 0-4 years of educations and 24 points (>4 years of education);
  • Not participating in any other type of physiotherapy or physical activity during the study period;
  • Complaining of difficulty in gait and mobility after stroke;
  • Able to stand up from a chair and walk some distance with or without auxiliary device;

Exclusion Criteria:

  • Hemorrhagic or ischemic progressing to hemorrhagic stroke;
  • Score ≥ 4 on the Visual Analogue Pain Scale;
  • Score ≥ 2 on the modificator Ashworth scale;
  • Visual disabilities;
  • Severe Aphasia;
  • Cardiovascular instability and/or other neurological disorders that may impair the mobility and gait.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02540096

Contacts
Contact: Zaqueline F Guerra, MSc 553232184249 zaqueline@oi.com.br
Contact: Giancarlo Lucchetti, MD, PhD 553288409001 g.lucchetti@yahoo.com.br

Locations
Brazil
Zaqueline Fernandes Guerra Recruiting
Juiz de Fora, Brazil, 36038295
Contact: Zaqueline Guerra         
Sponsors and Collaborators
Federal University of Juiz de Fora
Investigators
Principal Investigator: Zaqueline F Guerra Federal University of Juiz de Fora
  More Information

Publications:

Responsible Party: Zaqueline F. Guerra, MSc, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT02540096     History of Changes
Other Study ID Numbers: 43659515.4.0000.5103
Study First Received: September 1, 2015
Last Updated: August 9, 2016

Keywords provided by Zaqueline F. Guerra, Federal University of Juiz de Fora:
mental practice
motor imagery
hemiparesis
stroke
gait
mobility

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017