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Clinical Trials/NCT02540096
NCT02540096
Unknown
Not Applicable

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

Federal University of Juiz de Fora1 site in 1 country16 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Federal University of Juiz de Fora
Enrollment
16
Locations
1
Primary Endpoint
Change in Timed Up and Go (TUG)
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
July 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Juiz de Fora
Responsible Party
Principal Investigator
Principal Investigator

Zaqueline F. Guerra

MSc

Federal University of Juiz de Fora

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Quality of life(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
  • Change in Muscle strength(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
  • Change in Mental health(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
  • Change in TUG-ABS(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)

Study Sites (1)

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