Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

May 21, 2019 updated by: Zaqueline F. Guerra, Federal University of Juiz de Fora

Effects of Mental Practice for Mobility in Post-stroke Hemiparesis: Randomized Controlled Trial of Efficacy.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Juiz de Fora, Brazil, 36038295
        • Zaqueline Fernandes Guerra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
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)
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
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)
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
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)
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
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)
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Juiz de Fora

Investigators

  • Principal Investigator: Zaqueline F Guerra, Federal University of Juiz de Fora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43659515.4.0000.5103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Mental practice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe