Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Other: Mental practice
* Other: Cognitive training and Relaxation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Mental Practice)<br>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<br>* 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).<br>|
| Placebo Comparator: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up and Go (TUG) | 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 | 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 | 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 | 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 | Using Depression, anxiety and stress scale (DASS-21) | 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention | 
| Change in TUG-ABS | The Timed Up and Go Assessment of Biomechanical Strategies (TUG-ABS) | 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental practice, motor imagery, hemiparesis, stroke, gait, mobility