Clinical trial NCT02540096: Effects of Mental Practice for Mobility in Post-stroke Hemiparesis
Official title: Effects of Mental Practice for Mobility in Post-stroke Hemiparesis: Randomized Controlled Trial of Efficacy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: mental practice
motor imagery
hemiparesis
stroke
gait
mobility
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Timed Up and Go (TUG)
timeFrame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
measure: 5-Meter Walk Test
timeFrame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary outcomes:
measure: Change in Muscle strength
timeFrame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
measure: Change in Quality of life
timeFrame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
measure: Change in Mental health
timeFrame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
measure: Change in TUG-ABS
timeFrame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: Zaqueline Fernandes Guerra
Study officials:
affiliation: Federal University of Juiz de Fora
name: Zaqueline F Guerra
role: PRINCIPAL_INVESTIGATOR
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