StrokeNCT02540096
Effects of Mental Practice for Mobility in Post-stroke Hemiparesis
A study testing Mental practice and Cognitive training and Relaxation in people with Stroke and Hemiparesis, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Mental practice and Cognitive training and Relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Mental practice, Cognitive training and Relaxation
- Keywords
- mental practice, motor imagery, hemiparesis, stroke, gait, mobility
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental practiceOther
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).
Cognitive training and RelaxationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Mental Practice) | Experimental | 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. Receives: Other: Mental practice |
| Control group | Placebo comparator | 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. Receives: Other: Cognitive training and Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary outcomes (4)
Change in Muscle strength
Hand-held dynamometer (HDD) for measuring lower-limb muscle strength
Measured: 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)
Measured: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Change in Mental health
Using Depression, anxiety and stress scale (DASS-21)
Measured: 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)
Measured: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2019
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaqueline F. Guerra, Federal University of Juiz de Fora
- Investigators
- Zaqueline F Guerra, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540096
- Sponsor's protocol ID
- 43659515.4.0000.5103
- Status last verified
- May 2019
- First submitted
- 1 Sep 2015
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Paolucci S, Antonucci G, Grasso MG, Morelli D, Troisi E, Coiro P, Bragoni M. Early versus delayed inpatient stroke rehabilitation: a matched comparison conducted in Italy. Arch Phys Med Rehabil. 2000 Jun;81(6):695-700. doi: 10.1016/s0003-9993(00)90095-9.
PubMed 10857508Hadidi N, Buckwalter K, Lindquist R, Rangen C. Lessons learned in recruitment and retention of stroke survivors. J Neurosci Nurs. 2012 Apr;44(2):105-10. doi: 10.1097/JNN.0b013e3182478c96.
PubMed 22367274Zhang S, He WB, Chen NH. Causes of death among persons who survive an acute ischemic stroke. Curr Neurol Neurosci Rep. 2014 Aug;14(8):467. doi: 10.1007/s11910-014-0467-3.
PubMed 24951970Page SJ, Dunning K, Hermann V, Leonard A, Levine P. Longer versus shorter mental practice sessions for affected upper extremity movement after stroke: a randomized controlled trial. Clin Rehabil. 2011 Jul;25(7):627-37. doi: 10.1177/0269215510395793. Epub 2011 Mar 22.
PubMed 21427151Page SJ. Mental practice: a promising restorative technique in stroke rehabilitation. Top Stroke Rehabil. 2001 Autumn;8(3):54-63. doi: 10.1310/7WDU-2P4U-V2EA-76F8.
PubMed 14523738Page SJ, Levine P, Leonard AC. Effects of mental practice on affected limb use and function in chronic stroke. Arch Phys Med Rehabil. 2005 Mar;86(3):399-402. doi: 10.1016/j.apmr.2004.10.002.
PubMed 15759218Lotze M, Cohen LG. Volition and imagery in neurorehabilitation. Cogn Behav Neurol. 2006 Sep;19(3):135-40. doi: 10.1097/01.wnn.0000209875.56060.06.
PubMed 16957491Sirigu A, Duhamel JR. Motor and visual imagery as two complementary but neurally dissociable mental processes. J Cogn Neurosci. 2001 Oct 1;13(7):910-9. doi: 10.1162/089892901753165827.
PubMed 11595094Jeannerod M. Neural simulation of action: a unifying mechanism for motor cognition. Neuroimage. 2001 Jul;14(1 Pt 2):S103-9. doi: 10.1006/nimg.2001.0832.
PubMed 11373140Malouin F, Richards CL, Jackson PL, Lafleur MF, Durand A, Doyon J. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) for assessing motor imagery in persons with physical disabilities: a reliability and construct validity study. J Neurol Phys Ther. 2007 Mar;31(1):20-9. doi: 10.1097/01.npt.0000260567.24122.64.
PubMed 17419886Malouin F, Richards CL, Doyon J, Desrosiers J, Belleville S. Training mobility tasks after stroke with combined mental and physical practice: a feasibility study. Neurorehabil Neural Repair. 2004 Jun;18(2):66-75. doi: 10.1177/0888439004266304.
PubMed 15228801Malouin F, Richards CL, Durand A, Doyon J. Added value of mental practice combined with a small amount of physical practice on the relearning of rising and sitting post-stroke: a pilot study. J Neurol Phys Ther. 2009 Dec;33(4):195-202. doi: 10.1097/NPT.0b013e3181c2112b.
PubMed 20208464Malouin F, Richards CL, Durand A, Doyon J. Clinical assessment of motor imagery after stroke. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):330-40. doi: 10.1177/1545968307313499. Epub 2008 Mar 6.
PubMed 18326057Hesse S, Schauer M, Malezic M, Jahnke M, Mauritz KH. Quantitative analysis of rising from a chair in healthy and hemiparetic subjects. Scand J Rehabil Med. 1994 Sep;26(3):161-6.
PubMed 7801066Decety J. The neurophysiological basis of motor imagery. Behav Brain Res. 1996 May;77(1-2):45-52. doi: 10.1016/0166-4328(95)00225-1.
PubMed 8762158
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Practice for Mobility in Post-stroke Hemiparesis: Randomized Controlled Trial of Efficacy.
- ClinicalTrials.gov ID
- NCT02540096
- Acronym / sponsor ID
- 43659515.4.0000.5103
- Conditions
- Stroke, Hemiparesis
- Keywords
- mental practice, motor imagery, hemiparesis, stroke, gait, mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Mental Practice) | Experimental | Other: Mental practiceParticipants 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. |
| Control group | Placebo comparator | Other: Cognitive training and RelaxationParticipants 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. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental practiceThe 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). | Other | Intervention (Mental Practice) |
| Cognitive training and RelaxationCognitive 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. | Other | Control group |
Primary outcome
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)
4 secondary outcomes
Change in Muscle strength
Time frame: 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
Change in Mental health
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Background: PubMed 10857508Paolucci S, Antonucci G, Grasso MG, Morelli D, Troisi E, Coiro P, Bragoni M. Early versus delayed inpatient stroke rehabilitation: a matched comparison conducted in Italy. Arch Phys Med Rehabil. 2000 Jun;81(6):695-700. doi: 10.1016/s0003-9993(00)90095-9.
- Background: PubMed 22367274Hadidi N, Buckwalter K, Lindquist R, Rangen C. Lessons learned in recruitment and retention of stroke survivors. J Neurosci Nurs. 2012 Apr;44(2):105-10. doi: 10.1097/JNN.0b013e3182478c96.
- Background: PubMed 24951970Zhang S, He WB, Chen NH. Causes of death among persons who survive an acute ischemic stroke. Curr Neurol Neurosci Rep. 2014 Aug;14(8):467. doi: 10.1007/s11910-014-0467-3.
- Background: PubMed 21427151Page SJ, Dunning K, Hermann V, Leonard A, Levine P. Longer versus shorter mental practice sessions for affected upper extremity movement after stroke: a randomized controlled trial. Clin Rehabil. 2011 Jul;25(7):627-37. doi: 10.1177/0269215510395793. Epub 2011 Mar 22.
- Background: PubMed 14523738Page SJ. Mental practice: a promising restorative technique in stroke rehabilitation. Top Stroke Rehabil. 2001 Autumn;8(3):54-63. doi: 10.1310/7WDU-2P4U-V2EA-76F8.
- Background: PubMed 15759218Page SJ, Levine P, Leonard AC. Effects of mental practice on affected limb use and function in chronic stroke. Arch Phys Med Rehabil. 2005 Mar;86(3):399-402. doi: 10.1016/j.apmr.2004.10.002.
- Background: PubMed 16957491Lotze M, Cohen LG. Volition and imagery in neurorehabilitation. Cogn Behav Neurol. 2006 Sep;19(3):135-40. doi: 10.1097/01.wnn.0000209875.56060.06.
- Background: PubMed 11595094Sirigu A, Duhamel JR. Motor and visual imagery as two complementary but neurally dissociable mental processes. J Cogn Neurosci. 2001 Oct 1;13(7):910-9. doi: 10.1162/089892901753165827.
- Background: PubMed 11373140Jeannerod M. Neural simulation of action: a unifying mechanism for motor cognition. Neuroimage. 2001 Jul;14(1 Pt 2):S103-9. doi: 10.1006/nimg.2001.0832.
- Background: PubMed 17419886Malouin F, Richards CL, Jackson PL, Lafleur MF, Durand A, Doyon J. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) for assessing motor imagery in persons with physical disabilities: a reliability and construct validity study. J Neurol Phys Ther. 2007 Mar;31(1):20-9. doi: 10.1097/01.npt.0000260567.24122.64.
- Background: PubMed 15228801Malouin F, Richards CL, Doyon J, Desrosiers J, Belleville S. Training mobility tasks after stroke with combined mental and physical practice: a feasibility study. Neurorehabil Neural Repair. 2004 Jun;18(2):66-75. doi: 10.1177/0888439004266304.
- Background: PubMed 20208464Malouin F, Richards CL, Durand A, Doyon J. Added value of mental practice combined with a small amount of physical practice on the relearning of rising and sitting post-stroke: a pilot study. J Neurol Phys Ther. 2009 Dec;33(4):195-202. doi: 10.1097/NPT.0b013e3181c2112b.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaqueline F Guerra principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental practice and Cognitive training and Relaxation in people with Stroke and Hemiparesis, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Timed Up and Go (TUG) (time frame: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540096, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.