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Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

Primary Purpose

Stroke, Hemiparesis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mental practice
Cognitive training and Relaxation
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring mental practice, motor imagery, hemiparesis, stroke, gait, mobility

Eligibility Criteria

18 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zaqueline Fernandes Guerra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention (Mental Practice)

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
5-Meter Walk Test
This is a measure that examines the participant's gait speed (cut off 6 seconds)

Secondary Outcome Measures

Change in Muscle strength
Hand-held dynamometer (HDD) for measuring lower-limb muscle strength
Change in Quality of life
Using World Health Organization Quality of Life Instrument (WHOQOL-Bref)
Change in Mental health
Using Depression, anxiety and stress scale (DASS-21)
Change in TUG-ABS
The Timed "Up and Go" Assessment of Biomechanical Strategies (TUG-ABS)

Full Information

First Posted
September 1, 2015
Last Updated
May 21, 2019
Sponsor
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT02540096
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
mental practice, motor imagery, hemiparesis, stroke, gait, mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Mental Practice)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mental practice
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Cognitive training and Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Timed Up and Go (TUG)
Description
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
Time Frame
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Title
5-Meter Walk Test
Description
This is a measure that examines the participant's gait speed (cut off 6 seconds)
Time Frame
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary Outcome Measure Information:
Title
Change in Muscle strength
Description
Hand-held dynamometer (HDD) for measuring lower-limb muscle strength
Time Frame
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Title
Change in Quality of life
Description
Using World Health Organization Quality of Life Instrument (WHOQOL-Bref)
Time Frame
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Title
Change in Mental health
Description
Using Depression, anxiety and stress scale (DASS-21)
Time Frame
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Title
Change in TUG-ABS
Description
The Timed "Up and Go" Assessment of Biomechanical Strategies (TUG-ABS)
Time Frame
1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaqueline F Guerra
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zaqueline Fernandes Guerra
City
Juiz de Fora
ZIP/Postal Code
36038295
Country
Brazil

12. IPD Sharing Statement

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Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

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